Et Control Performance in Adult Population Surgery
Conditions
Brief summary
This is a clinical, single blind, randomized, prospective research study. The purpose of this pivotal study is to collect and analyze data on the investigational End tidal Control (Et Control) option feature. To demonstrate that End tidal Control (Et Control) performance is non-inferior to conventional anesthesia practice in an adult surgery population by comparing the performance of the Et Control Arm (investigational arm) to the Control Arm (fresh gas mode).
Detailed description
The purpose of this pivotal study is to demonstrate that End tidal Control performance is non-inferior to conventional anesthesia practice in an adult surgery population, and support a marketing application in the U.S. for clearance of this feature.
Interventions
DEVICEEt Control Feature
Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.
DEVICEConventional Fresh Gas
Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an end case is confirmed on the Aisys CS2 at the end of the anesthesia case.
Sponsors
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female 18 years old or greater. 2. Scheduled to undergo general inhaled anesthesia that can be safely exposed to 100% oxygen for up to 2 minutes during general anesthesia. 3. Expected to have airway secured with laryngeal mask airway (LMA) or endotracheal tube. 4. Undergoing a surgical procedure that is anticipated by the investigator to take greater than or equal to 1 hour (operative time measured from induction to cessation of general inhalation anesthetic). 5. American Society of Anesthesiologists (ASA) status classification system I through III: 1. ASA Physical Status 1 = a normal healthy patient 2. ASA Physical Status 2 = a patient with mild systemic disease 3. ASA Physical Status 3 = a patient with severe systemic disease 6. Undergoing intravenous induction. 7. Ability to provide written informed consent.
Exclusion criteria
1. Have emergency medical condition requiring surgery. 2. Are female subjects, who are pregnant or lactating. 3. Any subject undergoing cardiac bypass surgery. 4. Any subject undergoing open chest surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG) | Duration of each steady state, an average of approximately 60 minutes | Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). |
| Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Duration of each steady state, an average of approximately 60 minutes | Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Data obtained using the clinicians' or Investigators' recorded target (TGT) values of anesthetic agent and oxygen for the Control Arm and using the set target values for the Et Control Arm. |
| Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Duration of each steady state, an average of approximately 60 minutes | Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on clinicians' or Investigators' recorded target values (TGT) |
| Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG) | Duration of each steady state, an average of approximately 60 minutes | Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Steady state concentration is based on an extraction algorithm described in Appendix 2 of the protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Duration of each steady state, an average of approximately 60 minutes | Response time: time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT). |
| Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG) | Duration of each steady state, an average of approximately 60 minutes | Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). |
| Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Duration of each steady state, an average of approximately 60 minutes | Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT). |
| Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG) | Duration of each steady state, an average of approximately 60 minutes | Settling time: time to achieve the desired EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). |
| Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Duration of each steady state, an average of approximately 60 minutes | time to achieve the desired EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT). |
| Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Duration of each steady state, an average of approximately 60 minutes | Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT). |
| Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG) | Duration of each steady state, an average of approximately 60 minutes | Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). |
| Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Duration of each steady state, an average of approximately 60 minutes | Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT). |
| Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes) | Accuracy of Et Control in maintaining EtAA control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. As a measure of Absolute Difference between Steady State and Set EtAA Concentration (%). Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). |
| Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Duration of Surgery | Accuracy of ET Control in maintatining EtAA between user set target and settling end tidal concentrations. Calculated for ET Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. Values based on clinicians' or Investigators' recorded values (TGT). |
| Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes) | Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was \< 5% v/v. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). |
| Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes) | Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was \< 5% v/v. Values based on clinicians' or Investigators' recorded values (TGT). |
| Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG) | Duration of each steady state, an average of approximately 60 minutes | Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). |
| Efficacy Response Time EtAA Based on Extraction Algorithm (ALG) | Duration of each steady state, an average of approximately 60 minutes | Response time: time to reach 90% of the desired change in EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). |
| Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Duration of each steady state, an average of approximately 60 minutes | time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT). |
| Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG) | Duration of each steady state, an average of approximately 60 minutes. | Response time: time to reach 90% of the desired change in EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inhaled Anesthetic Agent | Duration of Procedure | Usage of inhaled anesthetic agent |
| Discharge From the Operating Room | End of surgery to time of last breath | Time to discharge from the operating room |
| User Interactions | Duration of Procedure | Number of user interactions |
Countries
United States
Participant flow
Recruitment details
Enrollment began in June 2017 and was completed in July 2018. 248 subjects were enrolled at 4 sites. Males and females,18 years or older and scheduled to undergo general inhaled anesthesia during surgery, were screened for enrollment into this study. Subjects enrolled were randomized at a 1:1 ratio to either the Et Control Arm or the Control Arm. Randomization was stratified based on the Investigator, subject's pre-existing hypertension status, and subject's ASA status classification.
Pre-assignment details
Subjects are considered enrolled at the time of informed consent. After consent, subjects were screened against the inclusion/exclusion criteria according to standard procedures of the investigational site.
Participants by arm
| Arm | Count |
|---|---|
| Et Control Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject.
Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. | 110 |
| Control Arm Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature.
Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an end case is confirmed on the Aisys CS2 at the end of the anesthesia case. | 118 |
| Total | 228 |
Baseline characteristics
| Characteristic | Et Control | Control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 27 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants | 91 Participants | 181 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 13 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants | 105 Participants | 203 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 20 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 11 Participants | 20 Participants |
| Race (NIH/OMB) White | 77 Participants | 81 Participants | 158 Participants |
| Region of Enrollment United States | 110 participants | 118 participants | 228 participants |
| Sex: Female, Male Female | 51 Participants | 63 Participants | 114 Participants |
| Sex: Female, Male Male | 59 Participants | 55 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 0 / 116 |
| other Total, other adverse events | 36 / 104 | 43 / 116 |
| serious Total, serious adverse events | 1 / 104 | 1 / 116 |
Outcome results
Primary
Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG)
Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Steady state concentration is based on an extraction algorithm described in Appendix 2 of the protocol.
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG) | 91.7 percent duration | Standard Deviation 10.82 |
| Control Arm | Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG) | 80.8 percent duration | Standard Deviation 17.93 |
Comparison: Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.p-value: <0.00195% CI: [6.89, 15.01]t-test, 2 sided
Primary
Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)
Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG) | 98.1 percent duration | Standard Deviation 2.76 |
| Control Arm | Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG) | 92.8 percent duration | Standard Deviation 14.38 |
Comparison: Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.p-value: <0.00195% CI: [2.64, 8.04]t-test, 2 sided
Primary
Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Data obtained using the clinicians' or Investigators' recorded target (TGT) values of anesthetic agent and oxygen for the Control Arm and using the set target values for the Et Control Arm.
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 98.0 percent duration | Standard Deviation 2.05 |
| Control Arm | Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 45.9 percent duration | Standard Deviation 31.45 |
Comparison: Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.p-value: <0.00195% CI: [46.25, 57.95]t-test, 2 sided
Primary
Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on clinicians' or Investigators' recorded target values (TGT)
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 98.8 percent duration | Standard Deviation 1.49 |
| Control Arm | Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 41.0 percent duration | Standard Deviation 40.65 |
Comparison: Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.p-value: <0.00195% CI: [35.56, 53.41]t-test, 2 sided
Secondary
Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
Accuracy of ET Control in maintatining EtAA between user set target and settling end tidal concentrations. Calculated for ET Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. Values based on clinicians' or Investigators' recorded values (TGT).
Time frame: Duration of Surgery
Population: Subjects Randomized to the ET control arm of the study who underwent surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 0.10 Absolute Difference (%) | Standard Deviation 0.054 |
| Control Arm | Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 0.03 Absolute Difference (%) | Standard Deviation 0.031 |
| ET Control - Sevoflurane | Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 0.04 Absolute Difference (%) | Standard Deviation 0.027 |
| ET Control - All | Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 0.05 Absolute Difference (%) | Standard Deviation 0.04 |
Secondary
Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)
Accuracy of Et Control in maintaining EtAA control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. As a measure of Absolute Difference between Steady State and Set EtAA Concentration (%). Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
Time frame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
Population: Subjects randomized to the ET control arm of the study who underwent surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | 0.11 Absolute Difference (%) | Standard Deviation 0.056 |
| Control Arm | Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | 0.04 Absolute Difference (%) | Standard Deviation 0.031 |
| ET Control - Sevoflurane | Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | 0.04 Absolute Difference (%) | Standard Deviation 0.026 |
| ET Control - All | Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | 0.05 Absolute Difference (%) | Standard Deviation 0.043 |
Secondary
Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was \< 5% v/v. Values based on clinicians' or Investigators' recorded values (TGT).
Time frame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
Population: Subjects randomized to the ET control arm of the study who underwent surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 0.62 Absolute Difference (%) | Standard Deviation 0.632 |
| Control Arm | Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 0.61 Absolute Difference (%) | Standard Deviation 0.585 |
| ET Control - Sevoflurane | Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 0.64 Absolute Difference (%) | Standard Deviation 0.863 |
| ET Control - All | Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 0.63 Absolute Difference (%) | Standard Deviation 0.774 |
Secondary
Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)
Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was \< 5% v/v. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
Time frame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
Population: Subjects randomized to the ET control arm of the study who underwent surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | 0.57 Absolute Difference (%) | Standard Deviation 0.594 |
| Control Arm | Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | 0.62 Absolute Difference (%) | Standard Deviation 0.613 |
| ET Control - Sevoflurane | Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | 0.64 Absolute Difference (%) | Standard Deviation 0.932 |
| ET Control - All | Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | 0.62 Absolute Difference (%) | Standard Deviation 0.818 |
Secondary
Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 2.14 percent to mean | Standard Deviation 6.277 |
| Control Arm | Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 11.13 percent to mean | Standard Deviation 20.662 |
Secondary
Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG)
Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG) | 3.47 percent to mean | Standard Deviation 8.238 |
| Control Arm | Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG) | 2.80 percent to mean | Standard Deviation 11.373 |
Secondary
Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 5.28 percent to mean | Standard Deviation 6.953 |
| Control Arm | Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 12.09 percent to mean | Standard Deviation 27.085 |
Secondary
Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG)
Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG) | 8.85 percent to mean | Standard Deviation 12.026 |
| Control Arm | Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG) | 6.54 percent to mean | Standard Deviation 13.576 |
Secondary
Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)
Response time: time to reach 90% of the desired change in EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy Response Time EtAA Based on Extraction Algorithm (ALG) | 73 Seconds | Standard Deviation 174.1 |
| Control Arm | Efficacy Response Time EtAA Based on Extraction Algorithm (ALG) | 196 Seconds | Standard Deviation 378.3 |
Secondary
Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 23 Seconds | Standard Deviation 40.9 |
| Control Arm | Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 196 Seconds | Standard Deviation 455 |
Secondary
Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
Response time: time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 129 Seconds | Standard Deviation 451.7 |
| Control Arm | Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 406 Seconds | Standard Deviation 727.8 |
Secondary
Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)
Response time: time to reach 90% of the desired change in EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
Time frame: Duration of each steady state, an average of approximately 60 minutes.
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG) | 93 Seconds | Standard Deviation 77.3 |
| Control Arm | Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG) | 246 Seconds | Standard Deviation 346.8 |
Secondary
Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 23 Seconds | Standard Deviation 40.9 |
| Control Arm | Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 196 Seconds | Standard Deviation 455 |
Secondary
Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)
Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG) | 105 Seconds | Standard Deviation 181.9 |
| Control Arm | Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG) | 165 Seconds | Standard Deviation 186.4 |
Secondary
Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
time to achieve the desired EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 167 Seconds | Standard Deviation 121.1 |
| Control Arm | Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | 815 Seconds | Standard Deviation 1327.2 |
Secondary
Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)
Settling time: time to achieve the desired EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
Time frame: Duration of each steady state, an average of approximately 60 minutes
Population: Intent-to-treat population includes all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Et Control | Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG) | 123 Seconds | Standard Deviation 117.5 |
| Control Arm | Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG) | 235 Seconds | Standard Deviation 213.2 |
Other Pre-specified
Discharge From the Operating Room
Time to discharge from the operating room
Time frame: End of surgery to time of last breath
Other Pre-specified
Inhaled Anesthetic Agent
Usage of inhaled anesthetic agent
Time frame: Duration of Procedure
Other Pre-specified
User Interactions
Number of user interactions
Time frame: Duration of Procedure