Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies

Study Overview
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Brief Summary
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The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.

Detailed Description
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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.

Official Title
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A Comparative Study of CO2 Exchange Patterns Between Valve-free Trocar (AirSeal®) Versus Standard Trocar (Endopath®) During Robotic Prostatectomies

Conditions
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Prostate Cancer, Pneumoperitoneum

Intervention / Treatment
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* Device: AirSeal System
* Device: Standard Endopath


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AirSeal System<br>This group receives the AirSeal System for intraoperative insufflation. | Device: AirSeal System<br>* To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.<br>* Other names: Valve-free Trocar;|
| Active Comparator: Standard Endopath<br>This group receives the Standard Endopath Trocar for intraoperative insufflation. | Device: Standard Endopath<br>* This group receives the Standard Endopath Trocar for intraoperative insufflation.<br>* Other names: Endopath Trocar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through end of procedure, an average of 156 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). | The amount of dissolved carbon dioxide (PaCO2) in arterial blood (mmHg) during the operative procedure | Baseline, 60 minutes, and at end of procedure, an average of 156 minutes | 
| 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. | Baseline, 60 minutes, and at end of procedure, an average of 156 minutes | 
| 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) | Baseline, 60 minutes, and at end of procedure, an average of 156 minutes | 
| Intraoperative Arterial Blood Gas Oxygen (mmHg). | The amount of dissolved oxygen (PaO2) in arterial blood (mmHg). | Baseline, 60 minutes, and end of procedure, an average of 156 minutes | 
| Number of Ventilator Interventions | The number of times the anesthesiologist had to adjust ventilator settings | Through end of procedure, an average of 156 minutes | 
| Procedure Time (Minutes) | The duration of the procedure | Through end of procedure, an average of 156 minutes | 
| Smoke Evacuation Quality | Smoke evacuation quality throughout the procedure was assessed by the surgeon as below average, average, or above average | Through end of procedure, an average of 156 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AirSeal, Trocar, Carbon Dioxide Exchange and Absorption