Obstructive Sleep Apnea, Obesity
Conditions
Keywords
Obstructive Sleep Apnea, total IV anesthesia, obesity, colonoscopy, Nasal cpap
Brief summary
The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and routine care with face mask for oxygen (O2).
Interventions
DEVICEStandard care with a facemask.
The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)
DEVICESuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)
The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)
Sponsors
Vyaire Medical
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing colonoscopy * American Society of Anesthesiology (ASA) Physical Status I-III * BMI ≥30 kg/m2 or suspected Obstructive Sleep Apnea
Exclusion criteria
* Inpatient status * Active Congestive Heart Failure Exacerbation * Untreated ischemic heart disease * Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma * Emergent procedures * Pregnancy * Previous enrollment in this study * Inability to provide informed consent * Additional medical testing planned for the same day * History of allergic reaction to Propofol * Tracheostomy * Supra-glottic or sub-glottic tumor * Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon). * Prisoners * Unable to fit SuperNoVa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time Taken From Initiation of Induction to the First Airway Intervention | From Initiation of Induction to the First Airway Intervention (about 16 minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Propofol Administered During the Procedure | during the procedure (about 45 minutes) | — |
| Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS) | prior to endoscopic intubation,during the procedure | This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness |
| Time Taken From Induction to Endoscopic Insertion | within 10 minutes of start of sedation | — |
| Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient | From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes) | — |
| Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient | From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes) | — |
| Number of Participants Who Received Airway Maneuvers | From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes) | — |
| Time Taken for Airway Maneuvers | From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes) | — |
| Amount of Propofol Administered During Induction | Within 5 minutes of the start of anesthesia | — |
| Time Taken for the Entire Procedure | from start of procedure to end of procedure (about 45 minutes) | — |
| Recovery Time as Assessed by the Time When Subject Was Ready for Discharge | at time of discharge( about one hour from end of procedure) | — |
| Recovery Time as Assessed by the Actual Time When Subject Was Discharged | at time of discharge( about one and a half hour from end of procedure) | — |
| Patient Satisfaction as Assessed by the Visual Analog Scale (VAS) | at time of discharge(about one hour from end of procedure) | This will be scored from 0-10, a higher score indicating more satisfaction |
| Number of Participants That Tolerated the SuperNO2VA™EtCO2 | from start of procedure to end of procedure (about 45 minutes) | — |
| Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS) | end of procedure (about 45 minutes from start) | This will be scored from 0-10, a higher score indicating more satisfaction |
| Number of Participants That Had Incidences of Cardiac Complications | during the procedure (about 45 minutes) | — |
| Reason for Airway Maneuvers | From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group B: SuperNO2VA™EtCO2 SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) | 71 |
| Group A: Standard Care With a Facemask. Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) | 68 |
| Total | 139 |
Baseline characteristics
| Characteristic | Group B: SuperNO2VA™EtCO2 | Group A: Standard Care With a Facemask. | Total |
|---|---|---|---|
| Age, Continuous | 58 years | 54.5 years | 56 years |
| American Society of Anesthesiology (ASA) Classification ASA I: A normal healthy patient | 0 Participants | 0 Participants | 0 Participants |
| American Society of Anesthesiology (ASA) Classification ASA II: A patient with mild systemic disease | 19 Participants | 21 Participants | 40 Participants |
| American Society of Anesthesiology (ASA) Classification ASA III: A patient with severe systemic disease | 51 Participants | 47 Participants | 98 Participants |
| American Society of Anesthesiology (ASA) Classification ASA IV: A patient with severe systemic disease that is a constant threat to life | 0 Participants | 0 Participants | 0 Participants |
| American Society of Anesthesiology (ASA) Classification ASA V: A moribund patient who is not expected to survive without the operation | 0 Participants | 0 Participants | 0 Participants |
| American Society of Anesthesiology (ASA) Classification ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index < 30 | 1 Participants | 2 Participants | 3 Participants |
| Body Mass Index 30 ≤ BMI < 40 (obesity) | 50 Participants | 49 Participants | 99 Participants |
| Body Mass Index ≥ 40 (Class 3 obesity) | 20 Participants | 17 Participants | 37 Participants |
| Body Mass Index | 36.6 kilograms per square meter | 35.2 kilograms per square meter | 35.9 kilograms per square meter |
| Ethnicity (NIH/OMB) Hispanic or Latino | 48 Participants | 45 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 23 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African-American | 15 Participants | 15 Participants | 30 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 55 Participants | 52 Participants | 107 Participants |
| Region of Enrollment United States | 71 participants | 68 participants | 139 participants |
| Sex: Female, Male Female | 46 Participants | 44 Participants | 90 Participants |
| Sex: Female, Male Male | 25 Participants | 24 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 68 |
| other Total, other adverse events | 0 / 71 | 0 / 68 |
| serious Total, serious adverse events | 2 / 71 | 0 / 68 |
Outcome results
Primary
Time Taken From Initiation of Induction to the First Airway Intervention
Time frame: From Initiation of Induction to the First Airway Intervention (about 16 minutes)
Population: 16 participants in the Group B: SuperNO2VA™EtCO2 needed airway intervention. 29 participants in the Group A: Standard care with a facemask needed airway intervention. Only the participants who needed airway intervention were analyzed for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Time Taken From Initiation of Induction to the First Airway Intervention | 5 minutes |
| Group A: Standard Care With a Facemask. | Time Taken From Initiation of Induction to the First Airway Intervention | 10 minutes |
Secondary
Amount of Propofol Administered During Induction
Time frame: Within 5 minutes of the start of anesthesia
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Amount of Propofol Administered During Induction | 70 milligrams |
| Group A: Standard Care With a Facemask. | Amount of Propofol Administered During Induction | 75 milligrams |
Secondary
Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS)
This will be scored from 0-10, a higher score indicating more satisfaction
Time frame: end of procedure (about 45 minutes from start)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS) | 8.5 score on a scale |
| Group A: Standard Care With a Facemask. | Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS) | 8 score on a scale |
Secondary
Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)
This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness
Time frame: prior to endoscopic intubation,during the procedure
Population: Data were not collected for this outcome measure because the assessment was not done by the observers. As a result, 0 observers completed the assessment, and therefore, no participants were analyzed in either study arm.
Secondary
Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient
Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Population: Zero participants had a procedural interruption.
Secondary
Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient
Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient | 0 number of times endoscope is removed |
| Group A: Standard Care With a Facemask. | Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient | 0 number of times endoscope is removed |
Secondary
Number of Participants That Had Incidences of Cardiac Complications
Time frame: during the procedure (about 45 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Number of Participants That Had Incidences of Cardiac Complications | 0 Participants |
| Group A: Standard Care With a Facemask. | Number of Participants That Had Incidences of Cardiac Complications | 0 Participants |
Secondary
Number of Participants That Tolerated the SuperNO2VA™EtCO2
Time frame: from start of procedure to end of procedure (about 45 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Number of Participants That Tolerated the SuperNO2VA™EtCO2 | 69 Participants |
Secondary
Number of Participants Who Received Airway Maneuvers
Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Number of Participants Who Received Airway Maneuvers | 16 Participants |
| Group A: Standard Care With a Facemask. | Number of Participants Who Received Airway Maneuvers | 29 Participants |
Secondary
Patient Satisfaction as Assessed by the Visual Analog Scale (VAS)
This will be scored from 0-10, a higher score indicating more satisfaction
Time frame: at time of discharge(about one hour from end of procedure)
Population: Data were not collected from 3 participants in the Group B: SuperNO2VA™EtCO2 arm because the participants did not complete the survey. Data were not collected from 1 participant in the Group A: Standard care with a facemask arm because the participant did not complete the survey.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Patient Satisfaction as Assessed by the Visual Analog Scale (VAS) | 10 score on a scale |
| Group A: Standard Care With a Facemask. | Patient Satisfaction as Assessed by the Visual Analog Scale (VAS) | 10 score on a scale |
Secondary
Reason for Airway Maneuvers
Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Population: 16 participants in the Group B: SuperNO2VA™EtCO2 needed airway intervention. 29 participants in the Group A: Standard care with a facemask needed airway intervention. Only the participants who needed airway intervention were analyzed for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Reason for Airway Maneuvers | Apnea | 2 Participants |
| Group B: SuperNO2VA™EtCO2 | Reason for Airway Maneuvers | Apnea and Desaturations <90% SpO2 | 2 Participants |
| Group B: SuperNO2VA™EtCO2 | Reason for Airway Maneuvers | Desaturations <90% SpO2 | 12 Participants |
| Group B: SuperNO2VA™EtCO2 | Reason for Airway Maneuvers | Other | 0 Participants |
| Group A: Standard Care With a Facemask. | Reason for Airway Maneuvers | Other | 1 Participants |
| Group A: Standard Care With a Facemask. | Reason for Airway Maneuvers | Apnea | 9 Participants |
| Group A: Standard Care With a Facemask. | Reason for Airway Maneuvers | Desaturations <90% SpO2 | 10 Participants |
| Group A: Standard Care With a Facemask. | Reason for Airway Maneuvers | Apnea and Desaturations <90% SpO2 | 9 Participants |
Secondary
Recovery Time as Assessed by the Actual Time When Subject Was Discharged
Time frame: at time of discharge( about one and a half hour from end of procedure)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Recovery Time as Assessed by the Actual Time When Subject Was Discharged | 81 minutes |
| Group A: Standard Care With a Facemask. | Recovery Time as Assessed by the Actual Time When Subject Was Discharged | 77 minutes |
Secondary
Recovery Time as Assessed by the Time When Subject Was Ready for Discharge
Time frame: at time of discharge( about one hour from end of procedure)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Recovery Time as Assessed by the Time When Subject Was Ready for Discharge | 48 minutes |
| Group A: Standard Care With a Facemask. | Recovery Time as Assessed by the Time When Subject Was Ready for Discharge | 46.5 minutes |
Secondary
Time Taken for Airway Maneuvers
Time frame: From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes)
Population: 16 participants who received airway maneuvers in the Group B: SuperNO2VA™EtCO2 arm were analyzed for the outcome measure. 29 participants who received airway maneuvers in the Group A: Standard care with a facemask arm were analyzed for the outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Time Taken for Airway Maneuvers | 172.5 seconds |
| Group A: Standard Care With a Facemask. | Time Taken for Airway Maneuvers | 131 seconds |
Secondary
Time Taken for the Entire Procedure
Time frame: from start of procedure to end of procedure (about 45 minutes)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Time Taken for the Entire Procedure | 33 minutes |
| Group A: Standard Care With a Facemask. | Time Taken for the Entire Procedure | 33.5 minutes |
Secondary
Time Taken From Induction to Endoscopic Insertion
Time frame: within 10 minutes of start of sedation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Time Taken From Induction to Endoscopic Insertion | 2 minutes |
| Group A: Standard Care With a Facemask. | Time Taken From Induction to Endoscopic Insertion | 3 minutes |
Secondary
Total Amount of Propofol Administered During the Procedure
Time frame: during the procedure (about 45 minutes)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group B: SuperNO2VA™EtCO2 | Total Amount of Propofol Administered During the Procedure | 360 milligrams |
| Group A: Standard Care With a Facemask. | Total Amount of Propofol Administered During the Procedure | 253 milligrams |