Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies

Not Applicable

Completed

• Conditions: Pneumoperitoneum; Prostate Cancer
• Interventions: Device: AirSeal System; Device: Standard Endopath

• Registration Number: NCT02114164
• Lead Sponsor: OhioHealth

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.

Study Timeline

• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-04-11
• Study First Posted: 2014-04-15
• Study Start: 2016-08
• Primary Completion: 2018-05-03
• Study Completion: 2019-07-15
• Results First Submitted: 2021-09-10
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Results First Posted: 2021-11-26
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AirSeal System	AirSeal System	This group receives the AirSeal System for intraoperative insufflation.
Standard Endopath	Standard Endopath	This group receives the Standard Endopath Trocar for intraoperative insufflation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 Oxygen (mmHg).	Baseline, 60 minutes, and end of procedure, an average of 156 minutes	The amount of dissolved oxygen (PaO2) in arterial blood (mmHg).
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 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
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.
Number of Ventilator Interventions	Through end of procedure, an average of 156 minutes	The number of times the anesthesiologist had to adjust ventilator settings
Procedure Time (Minutes)	Through end of procedure, an average of 156 minutes	The duration of the procedure

Trial Locations

Locations (1)

Dublin Methodist Hospital; 🇺🇸 Columbus, Ohio, United States