Back to resultsCO2 Absorption During Laparoscopy
Primary Purpose
Pneumoperitoneum
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
alteration of the insufflation gas
full conditioning
standard pneumoperitoneum
Sponsored by
About this trial
This is an interventional prevention trial for Pneumoperitoneum focused on measuring women undergoing laparoscopic surgery for: hysterectomy, colpopexy, endometriosis, adhesions or myomas
Eligibility Criteria
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…)
Sites / Locations
- UZ Leuven, campus Gasthuisberg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
4% oxygen
full conditioning
CO2 pneumoperitoneum
Arm Description
addition of 4% oxygen to the CO2 pneumoperitoneum
full conditioning of the peritoneal cavity by the laparoscopic gas: 4% oxygen, 10% nitrous oxide, humidification and set temperature of 32°C
standard laparoscopy with CO2 pneumoperitoneum
Outcomes
Primary Outcome Measures
CO2 absorption
Measurement of end tidal CO2 during laparoscopic surgery; a decrease would improve safety (less hypercarbia)
Secondary Outcome Measures
hemodynamic alterations
control of other hemodynamic alterions during laparoscopic surgery.
Full Information
NCT ID
NCT01340989
First Posted
April 21, 2011
Last Updated
October 25, 2011
Sponsor
University Hospital, Gasthuisberg
1. Study Identification
Unique Protocol Identification Number
NCT01340989
Brief Title
CO2 Absorption During Laparoscopy
Official Title
Evaluation of Adding 4% of Oxygen and 10% of Nitrous Oxide to the CO2 Pneumoperitoneum Upon CO2 Resorption.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gasthuisberg
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumoperitoneum
Keywords
women undergoing laparoscopic surgery for: hysterectomy, colpopexy, endometriosis, adhesions or myomas
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
4% oxygen
Arm Type
Experimental
Arm Description
addition of 4% oxygen to the CO2 pneumoperitoneum
Arm Title
full conditioning
Arm Type
Experimental
Arm Description
full conditioning of the peritoneal cavity by the laparoscopic gas: 4% oxygen, 10% nitrous oxide, humidification and set temperature of 32°C
Arm Title
CO2 pneumoperitoneum
Arm Type
Active Comparator
Arm Description
standard laparoscopy with CO2 pneumoperitoneum
Intervention Type
Procedure
Intervention Name(s)
alteration of the insufflation gas
Intervention Description
addition of 4% oxygen
Intervention Type
Procedure
Intervention Name(s)
full conditioning
Intervention Description
addition of 4% oxygen + 10% nitrous oxide to the peritoneum
humidification
set temperature of 32°C
Intervention Type
Procedure
Intervention Name(s)
standard pneumoperitoneum
Intervention Description
no intervention besides the use of CO2
Primary Outcome Measure Information:
Title
CO2 absorption
Description
Measurement of end tidal CO2 during laparoscopic surgery; a decrease would improve safety (less hypercarbia)
Time Frame
measurements for 60 to 240 minutes on average during surgery
Secondary Outcome Measure Information:
Title
hemodynamic alterations
Description
control of other hemodynamic alterions during laparoscopic surgery.
Time Frame
measurements for 60 to 240 minutes on average during surgery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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…)
Facility Information:
Facility Name
UZ Leuven, campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
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CO2 Absorption During Laparoscopy
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