Pneumoperitoneum, Prostate Cancer
Conditions
Keywords
AirSeal, Trocar, Carbon Dioxide Exchange and Absorption
Brief summary
The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.
Detailed description
The primary observation to be made is the level of carbon dioxide in the arterial blood, specifically when the patient is insufflated and deflated during the surgery. As a result of the consistent pressure that the AirSeal® system maintains, carbon dioxide will be absorbed in lower levels when compared to the standard of care systems in which fluctuations in intra-peritoneum pressure are seen.
Interventions
DEVICEAirSeal System
To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.
DEVICEStandard Endopath
This group receives the Standard Endopath Trocar for intraoperative insufflation.
Sponsors
SurgiQuest, Inc.
OhioHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>18 * Eligible and elect to undergo robotic prostatectomy surgery @ OhioHealth Dublin Methodist Hospital
Exclusion criteria
* Age \< 18 * Emergency surgery * Ascites * BMI\>44 or \<18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Pneumoperitoneal Pressure (mmHg) | Through end of procedure, an average of 156 minutes | Pneumoperitoneal pressure is the pressure exerted by air or gas in the abdominal (peritoneal) cavity. As the amount of air/gas increases, the pressure (mmHg) increases. The highest pressure that occurred during the procedure was compared between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time (Minutes) | Through end of procedure, an average of 156 minutes | The duration of the procedure |
| Smoke Evacuation Quality | Through end of procedure, an average of 156 minutes | Smoke evacuation quality throughout the procedure was assessed by the surgeon as below average, average, or above average |
| Intraoperative Arterial Blood Gas Oxygen (mmHg). | Baseline, 60 minutes, and end of procedure, an average of 156 minutes | The amount of dissolved oxygen (PaO2) in arterial blood (mmHg). |
| Number of Ventilator Interventions | Through end of procedure, an average of 156 minutes | The number of times the anesthesiologist had to adjust ventilator settings |
| End-tidal Carbon Dioxide Pressure (mmHg) | Baseline, 60 minutes, and at end of procedure, an average of 156 minutes | End-tidal carbon dioxide pressure is the partial pressure of carbon dioxide at the end of exhalation. Normal value is 35-45 mmHg. |
| Carbon Dioxide Elimination (mmHg) | Baseline, 60 minutes, and at end of procedure, an average of 156 minutes | Carbon dioxide elimination was calculated using end-tidal carbon dioxide pressure (EtCO2), tidal volume, respiratory rate, barometric pressure (pB = 760mm Hg), partial pressure of water vapor (PH2O = 13 mm Hg), and patient weight (kg) |
| Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). | Baseline, 60 minutes, and at end of procedure, an average of 156 minutes | The amount of dissolved carbon dioxide (PaCO2) in arterial blood (mmHg) during the operative procedure |
Countries
United States
Participant flow
Pre-assignment details
9 participants withdrew from the study after providing informed consent but before being randomized to a group and receiving an intervention
Participants by arm
| Arm | Count |
|---|---|
| AirSeal System This group receives the AirSeal System for intraoperative insufflation.
AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar. | 50 |
| Standard Endopath This group receives the Standard Endopath Trocar for intraoperative insufflation.
Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Standard Endopath | Total | AirSeal System |
|---|---|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 6.7 | 61.5 years STANDARD_DEVIATION 6.2 | 61.0 years STANDARD_DEVIATION 5.6 |
| Body Mass Index (BMI) | 28.3 kg/m^2 STANDARD_DEVIATION 3.3 | 28.7 kg/m^2 STANDARD_DEVIATION 3.8 | 29.1 kg/m^2 STANDARD_DEVIATION 4.3 |
| Preoperative creatinine | 0.96 mg/dL STANDARD_DEVIATION 0.2 | 0.92 mg/dL STANDARD_DEVIATION 0.1 | 0.89 mg/dL STANDARD_DEVIATION 0.1 |
| Preoperative hemoglobin | 14.7 g/dL STANDARD_DEVIATION 1 | 14.8 g/dL STANDARD_DEVIATION 1 | 15.1 g/dL STANDARD_DEVIATION 1 |
| Race/Ethnicity, Customized Race/Ethnicity African American | 7 Participants | 7 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 42 Participants | 92 Participants | 50 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | 50 Participants | 100 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 1 / 50 | 3 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Intraoperative Pneumoperitoneal Pressure (mmHg)
Pneumoperitoneal pressure is the pressure exerted by air or gas in the abdominal (peritoneal) cavity. As the amount of air/gas increases, the pressure (mmHg) increases. The highest pressure that occurred during the procedure was compared between groups.
Time frame: Through end of procedure, an average of 156 minutes
Population: Data were missing for one participant in each group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AirSeal System | Intraoperative Pneumoperitoneal Pressure (mmHg) | 7.9 mmHg | Standard Deviation 2.5 |
| Standard Endopath | Intraoperative Pneumoperitoneal Pressure (mmHg) | 9.9 mmHg | Standard Deviation 2.9 |
p-value: <0.001t-test, 2 sided
Secondary
Carbon Dioxide Elimination (mmHg)
Carbon dioxide elimination was calculated using end-tidal carbon dioxide pressure (EtCO2), tidal volume, respiratory rate, barometric pressure (pB = 760mm Hg), partial pressure of water vapor (PH2O = 13 mm Hg), and patient weight (kg)
Time frame: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
Population: Missing data for eight, six, and nine AirSeal participants at baseline, 60 minutes, and end of procedure, respectively. Missing data for eight, seven, and eight Standard Endopath participants at baseline, 60 minutes, and end of procedure, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AirSeal System | Carbon Dioxide Elimination (mmHg) | Baseline | 3.15 mmHg | Standard Deviation 0.67 |
| AirSeal System | Carbon Dioxide Elimination (mmHg) | 60 minutes | 3.24 mmHg | Standard Deviation 0.74 |
| AirSeal System | Carbon Dioxide Elimination (mmHg) | End of procedure | 3.04 mmHg | Standard Deviation 1.35 |
| Standard Endopath | Carbon Dioxide Elimination (mmHg) | Baseline | 3.28 mmHg | Standard Deviation 0.64 |
| Standard Endopath | Carbon Dioxide Elimination (mmHg) | 60 minutes | 3.28 mmHg | Standard Deviation 0.6 |
| Standard Endopath | Carbon Dioxide Elimination (mmHg) | End of procedure | 3.11 mmHg | Standard Deviation 0.65 |
p-value: 0.42t-test, 2 sided
p-value: 0.75t-test, 2 sided
p-value: 0.99t-test, 2 sided
Secondary
End-tidal Carbon Dioxide Pressure (mmHg)
End-tidal carbon dioxide pressure is the partial pressure of carbon dioxide at the end of exhalation. Normal value is 35-45 mmHg.
Time frame: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
Population: Missing data for five, five, and seven AirSeal participants at baseline, 60 minutes, and end of procedure, respectively. Missing data for five, four, and four participants at baseline, 60 minutes, and end of procedure, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AirSeal System | End-tidal Carbon Dioxide Pressure (mmHg) | Baseline | 31.47 mmHg | Standard Deviation 3.9 |
| AirSeal System | End-tidal Carbon Dioxide Pressure (mmHg) | 60 Minutes | 32.80 mmHg | Standard Deviation 3.6 |
| AirSeal System | End-tidal Carbon Dioxide Pressure (mmHg) | End of procedure | 34.77 mmHg | Standard Deviation 8.9 |
| Standard Endopath | End-tidal Carbon Dioxide Pressure (mmHg) | Baseline | 29.96 mmHg | Standard Deviation 3.1 |
| Standard Endopath | End-tidal Carbon Dioxide Pressure (mmHg) | 60 Minutes | 30.96 mmHg | Standard Deviation 3.2 |
| Standard Endopath | End-tidal Carbon Dioxide Pressure (mmHg) | End of procedure | 34.17 mmHg | Standard Deviation 7.2 |
p-value: 0.13t-test, 2 sided
p-value: 0.018t-test, 2 sided
p-value: 0.712t-test, 2 sided
Secondary
Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg).
The amount of dissolved carbon dioxide (PaCO2) in arterial blood (mmHg) during the operative procedure
Time frame: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
Population: Data were missing for one participant in the Standard Endopath group at all time points. Data were missing for two AirSeal participants at baseline and 60 minutes, and for one AirSeal participant at end of procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AirSeal System | Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). | Baseline | 39.5 mmHg | Standard Deviation 4.9 |
| AirSeal System | Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). | 60 minutes | 41.5 mmHg | Standard Deviation 7.7 |
| AirSeal System | Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). | End of procedure | 45.1 mmHg | Standard Deviation 6.1 |
| Standard Endopath | Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). | Baseline | 39.2 mmHg | Standard Deviation 5.3 |
| Standard Endopath | Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). | 60 minutes | 41.2 mmHg | Standard Deviation 5.2 |
| Standard Endopath | Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). | End of procedure | 44.1 mmHg | Standard Deviation 5.5 |
p-value: 0.39t-test, 2 sided
Secondary
Intraoperative Arterial Blood Gas Oxygen (mmHg).
The amount of dissolved oxygen (PaO2) in arterial blood (mmHg).
Time frame: Baseline, 60 minutes, and end of procedure, an average of 156 minutes
Population: Data missing for one Standard Endopath participant at all time points. Data missing for two AirSeal participants at baseline and 60 minutes, and one AirSeal participant at end of procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AirSeal System | Intraoperative Arterial Blood Gas Oxygen (mmHg). | Baseline | 361.9 mmHg | Standard Deviation 79.3 |
| AirSeal System | Intraoperative Arterial Blood Gas Oxygen (mmHg). | 60 minutes | 283.9 mmHg | Standard Deviation 115.4 |
| AirSeal System | Intraoperative Arterial Blood Gas Oxygen (mmHg). | End of procedure | 286.5 mmHg | Standard Deviation 99.1 |
| Standard Endopath | Intraoperative Arterial Blood Gas Oxygen (mmHg). | Baseline | 364.3 mmHg | Standard Deviation 81.9 |
| Standard Endopath | Intraoperative Arterial Blood Gas Oxygen (mmHg). | 60 minutes | 294 mmHg | Standard Deviation 105 |
| Standard Endopath | Intraoperative Arterial Blood Gas Oxygen (mmHg). | End of procedure | 290.2 mmHg | Standard Deviation 99.4 |
p-value: 0.88t-test, 2 sided
p-value: 0.65t-test, 2 sided
p-value: 0.86t-test, 2 sided
Secondary
Number of Ventilator Interventions
The number of times the anesthesiologist had to adjust ventilator settings
Time frame: Through end of procedure, an average of 156 minutes
Population: Missing data for two participants in the AirSeal group and one participant in the Standard Endopath group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AirSeal System | Number of Ventilator Interventions | 0.69 Count of interventions | Standard Deviation 1.1 |
| Standard Endopath | Number of Ventilator Interventions | 0.66 Count of interventions | Standard Deviation 0.9 |
p-value: 0.41Zero-inflated Poisson regression
Secondary
Procedure Time (Minutes)
The duration of the procedure
Time frame: Through end of procedure, an average of 156 minutes
Population: Missing data for one participant in the AirSeal group and one participant in the Standard Endopath group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AirSeal System | Procedure Time (Minutes) | 158.6 Minutes | Standard Deviation 22.4 |
| Standard Endopath | Procedure Time (Minutes) | 153.0 Minutes | Standard Deviation 19.9 |
p-value: 0.09t-test, 2 sided
Secondary
Smoke Evacuation Quality
Smoke evacuation quality throughout the procedure was assessed by the surgeon as below average, average, or above average
Time frame: Through end of procedure, an average of 156 minutes
Population: Missing data for one participant in the AirSeal group and two participants in the Standard Endopath group
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AirSeal System | Smoke Evacuation Quality | Above Average | 20 Participants |
| AirSeal System | Smoke Evacuation Quality | Below Average | 4 Participants |
| AirSeal System | Smoke Evacuation Quality | Average | 25 Participants |
| Standard Endopath | Smoke Evacuation Quality | Average | 18 Participants |
| Standard Endopath | Smoke Evacuation Quality | Below Average | 16 Participants |
| Standard Endopath | Smoke Evacuation Quality | Above Average | 14 Participants |
p-value: <0.001Chi-squared