Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114164
• Other study ID #: OH1-13-00489
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: July 15, 2019

Study information

• Verified date: October 2021
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: July 15, 2019
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumoperitoneum
• Prostate Cancer

Intervention

Device:
• AirSeal System
To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.
• Standard Endopath
This group receives the Standard Endopath Trocar for intraoperative insufflation.

Locations

Country	Name	City	State
United States	Dublin Methodist Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
OhioHealth	SurgiQuest, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Through end of procedure, an average of 156 minutes
Secondary	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
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.	Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
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)	Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
Secondary	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
Secondary	Number of Ventilator Interventions	The number of times the anesthesiologist had to adjust ventilator settings	Through end of procedure, an average of 156 minutes
Secondary	Procedure Time (Minutes)	The duration of the procedure	Through end of procedure, an average of 156 minutes
Secondary	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