CO2 Absorption During Laparoscopy

October 25, 2011 updated by: Jasper Verguts, University Hospital, Gasthuisberg

Evaluation of Adding 4% of Oxygen and 10% of Nitrous Oxide to the CO2 Pneumoperitoneum Upon CO2 Resorption.

CO2 absorption from the pneumoperitoneum increases over time during laparoscopic procedures. Adding 4% of oxygen to the carbon dioxide was shown in rabbits to decrease CO2 resorbtion through prevention of mesothelial hypoxia. We want to prove this concept in human and expand it to the use of full conditioning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In order to confirm the animal data in the human, a first RCT was performed in which 20 women undergoing a laparoscopy for at least 60 minutes were randomised to a pneumoperitoneum with either 100% carbon dioxide or 96% carbon dioxide plus 4% of oxygen. Insufflation pressure and Trendelenburg were standardised at 15 mm Hg and 30° respectively. In a second trial women were randomized to either 100% carbon dioxide or 86% carbon dioxide plus 4% of oxygen + 10% nitrous oxide + humidification and set temperature of 32°C of the peritoneal cavity.

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven, Campus Gasthuisberg

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women/men planned to undergo a laparoscopic intervention for at least 1 hour and having signed the informed consent

Exclusion Criteria:

  • Pregnancy
  • Immunodeficiency
  • Refuse or unable to sign informed consent
  • Chronic disease (i.e. COPD, Crohn, cardiac…)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4% oxygen
addition of 4% oxygen to the CO2 pneumoperitoneum
Procedure: alteration of the insufflation gas
addition of 4% oxygen
Experimental: full conditioning
full conditioning of the peritoneal cavity by the laparoscopic gas: 4% oxygen, 10% nitrous oxide, humidification and set temperature of 32°C
Procedure: full conditioning

addition of 4% oxygen + 10% nitrous oxide to the peritoneum

  • humidification
  • set temperature of 32°C
Active Comparator: CO2 pneumoperitoneum
standard laparoscopy with CO2 pneumoperitoneum
Procedure: standard pneumoperitoneum
no intervention besides the use of CO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CO2 absorption
Time Frame: measurements for 60 to 240 minutes on average during surgery
Measurement of end tidal CO2 during laparoscopic surgery; a decrease would improve safety (less hypercarbia)
measurements for 60 to 240 minutes on average during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemodynamic alterations
Time Frame: measurements for 60 to 240 minutes on average during surgery
control of other hemodynamic alterions during laparoscopic surgery.
measurements for 60 to 240 minutes on average during surgery

Collaborators and Investigators

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

Sponsor

University Hospital, Gasthuisberg

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, 2006

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 22, 2011

First Posted (Estimate)

April 25, 2011

Study Record Updates

Last Update Posted (Estimate)

October 26, 2011

Last Update Submitted That Met QC Criteria

October 25, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s52645

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 alteration of the insufflation gas

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe