PneumoperitoneumNCT01340989
CO2 Absorption During Laparoscopy
A study testing alteration of the insufflation gas, full conditioning and standard pneumoperitoneum in people with Pneumoperitoneum, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pneumoperitoneum
- What is being tested?
- alteration of the insufflation gas, full conditioning and standard pneumoperitoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2006to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women/men planned to undergo a laparoscopic intervention for at least 1 hour and having signed the informed consent
Who cannot join
- Pregnancy
- Immunodeficiency
- Refuse or unable to sign informed consent
- Chronic disease (i.e. COPD, Crohn, cardiac…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumoperitoneum
- Being tested
- alteration of the insufflation gas, full conditioning, standard pneumoperitoneum
- Keywords
- women undergoing laparoscopic surgery for: hysterectomy, colpopexy, endometriosis, adhesions or myomas
- Medical subject headings
- Pneumoperitoneum, Endometriosis, Tissue Adhesions, Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alteration of the insufflation gasProcedure or surgery
addition of 4% oxygen
full conditioningProcedure or surgery
addition of 4% oxygen + 10% nitrous oxide to the peritoneum
- humidification
- set temperature of 32°C
standard pneumoperitoneumProcedure or surgery
no intervention besides the use of CO2
| Study group | Role | What they receive |
|---|---|---|
| 4% oxygen | Experimental | addition of 4% oxygen to the CO2 pneumoperitoneum Receives: Procedure: alteration of the insufflation gas |
| full conditioning | Experimental | full conditioning of the peritoneal cavity by the laparoscopic gas: 4% oxygen, 10% nitrous oxide, humidification and set temperature of 32°C Receives: Procedure: full conditioning |
| CO2 pneumoperitoneum | Active comparator | standard laparoscopy with CO2 pneumoperitoneum Receives: Procedure: standard pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
CO2 absorption
Measurement of end tidal CO2 during laparoscopic surgery; a decrease would improve safety (less hypercarbia)
Measured: measurements for 60 to 240 minutes on average during surgery
Secondary outcomes (1)
hemodynamic alterations
control of other hemodynamic alterions during laparoscopic surgery.
Measured: measurements for 60 to 240 minutes on average during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startAug 2006
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoperitoneumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasper Verguts, University Hospital, Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340989
- Sponsor's protocol ID
- s52645
- Status last verified
- Oct 2011
- First submitted
- 21 Apr 2011
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adding 4% of Oxygen and 10% of Nitrous Oxide to the CO2 Pneumoperitoneum Upon CO2 Resorption.
- ClinicalTrials.gov ID
- NCT01340989
- Acronym / sponsor ID
- s52645
- Conditions
- Pneumoperitoneum
- Keywords
- women undergoing laparoscopic surgery for: hysterectomy, colpopexy, endometriosis, adhesions or myomas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4% oxygen | Experimental | Procedure: alteration of the insufflation gasaddition of 4% oxygen to the CO2 pneumoperitoneum |
| full conditioning | Experimental | Procedure: full conditioningfull conditioning of the peritoneal cavity by the laparoscopic gas: 4% oxygen, 10% nitrous oxide, humidification and set temperature of 32°C |
| CO2 pneumoperitoneum | Active comparator | Procedure: standard pneumoperitoneumstandard laparoscopy with CO2 pneumoperitoneum |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women/men planned to undergo a laparoscopic intervention for at least 1 hour and having signed the informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- Immunodeficiency
- Refuse or unable to sign informed consent
- Chronic disease (i.e. COPD, Crohn, cardiac…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alteration of the insufflation gasaddition of 4% oxygen | Procedure or surgery | 4% oxygen |
| full conditioningaddition of 4% oxygen + 10% nitrous oxide to the peritoneum * humidification * set temperature of 32°C | Procedure or surgery | full conditioning |
| standard pneumoperitoneumno intervention besides the use of CO2 | Procedure or surgery | CO2 pneumoperitoneum |
Primary outcome
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)
1 secondary outcome
hemodynamic alterations
Time frame: measurements for 60 to 240 minutes on average during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alteration of the insufflation gas, full conditioning and standard pneumoperitoneum in people with Pneumoperitoneum, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CO2 absorption (time frame: measurements for 60 to 240 minutes on average during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2011.