Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies

October 28, 2021 updated by: OhioHealth

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43016
        • Dublin Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Pneumoperitoneal Pressure (mmHg)
Time Frame: 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.
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).
Time Frame: 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
Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
End-tidal Carbon Dioxide Pressure (mmHg)
Time Frame: 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.
Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
Carbon Dioxide Elimination (mmHg)
Time Frame: 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)
Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
Intraoperative Arterial Blood Gas Oxygen (mmHg).
Time Frame: Baseline, 60 minutes, and end of procedure, an average of 156 minutes
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
Time Frame: Through end of procedure, an average of 156 minutes
The number of times the anesthesiologist had to adjust ventilator settings
Through end of procedure, an average of 156 minutes
Procedure Time (Minutes)
Time Frame: Through end of procedure, an average of 156 minutes
The duration of the procedure
Through end of procedure, an average of 156 minutes
Smoke Evacuation Quality
Time Frame: 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
Through end of procedure, an average of 156 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OhioHealth

Collaborators

SurgiQuest, Inc.

Investigators

  • Principal Investigator: Ronney Abaza, MD,FACS, OhioHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

May 3, 2018

Study Completion (Actual)

July 15, 2019

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

April 11, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OH1-13-00489

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumoperitoneum

Clinical Trials on AirSeal System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe