CO2 Absorption During Laparoscopy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pneumoperitoneum

Intervention / Treatment
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* Procedure: alteration of the insufflation gas
* Procedure: full conditioning
* Procedure: standard pneumoperitoneum


Participation Criteria
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Eligibility Criteria
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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…)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4% oxygen<br>addition of 4% oxygen to the CO2 pneumoperitoneum | Procedure: alteration of the insufflation gas<br>* addition of 4% oxygen<br>|
| Experimental: full conditioning<br>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<br>* addition of 4% oxygen + 10% nitrous oxide to the peritoneum humidification set temperature of 32°C<br>|
| Active Comparator: CO2 pneumoperitoneum<br>standard laparoscopy with CO2 pneumoperitoneum | Procedure: standard pneumoperitoneum<br>* no intervention besides the use of CO2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CO2 absorption | 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 | control of other hemodynamic alterions during laparoscopic surgery. | measurements for 60 to 240 minutes on average during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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women undergoing laparoscopic surgery for: hysterectomy, colpopexy, endometriosis, adhesions or myomas