ObesityNCT00224653
Comparison Between Volume Controlled Ventilation and Pressure Controlled Ventilation
A study testing Mechanical Ventilation in people with Obesity and Reduced Lung Compliance., run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To assess the potential benefits on mechanical ventilation plateau pressure of pressure controlled mode versus volume controlled mode for laparoscopic bariatric surgery in obese patients (BMI > 35). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Reduced Lung Compliance., Anesthesia.
- What is being tested?
- Mechanical Ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to Jun 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients are over 18 years old and give their inform consent
- morbid obesity(BMI>35)
- laparoscopic bariatric surgery
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Georges Pompidou European Hospital
Paris, Île-de-France Region, 75908 cedex 15
About this study
To assess the potential benefits on mechanical ventilation plateau pressure of pressure controlled mode versus volume controlled mode for laparoscopic bariatric surgery in obese patients (BMI > 35). High plateau pressures encountered in obese patients due to their reduced pulmonary compliance could be lowered using pressure controlled mechanical ventilation.
Read the detailed description
All patients are over 18 years old and give their inform consent after approval of the study protocol by an ethic committee. Anesthesia is standardized and all patients are intubated. Precise protocols are used to perform pressure and volume controlled ventilation in order to regulate End-Tidal CO2 between 33 and 35 mmHg. Primary goal is comparison of plateau pressures observed in the 2 ventilation modes after 45 minutes of pneumoperitoneum. Secondary goals are : comparison of PaO2 and PaCO2 after 45 minutes of pneumoperitoneum and after 2 hours spent in post-anesthesia care unit ; comparison of total respiratory resistances and peak flow generated between the 2 modes.
- Conditions
- Obesity, Reduced Lung Compliance., Anesthesia., Laparoscopy.
- Being tested
- Mechanical Ventilation
- Keywords
- Obesity., Respiration. Respiration, artificial., Ventilation. Pressure controlled. Volume controlled.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical VentilationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Plateau pressures generated by mechanical ventilation after 45 minutes of pneumoperitoneum.
Secondary outcomes (1)
Comparison of PaO2 and PaCO2 after 45 minutes of pneumoperitoneum and after 2 hours spent in post-anesthesia care unit ; comparison of total respiratory resistances and peak flow generated between the 2 modes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startJan 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Philippe CADI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224653
- Sponsor's protocol ID
- P040405
- Other IDs
- PS040405
- Status last verified
- Sep 2005
- First submitted
- 16 Sep 2005
- Last updated
- 13 Apr 2006
- Results posted
- No
Publications
Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.
PubMed 12707159
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Volume Controlled Ventilation and Pressure Controlled Ventilation
- ClinicalTrials.gov ID
- NCT00224653
- Acronym / sponsor ID
- P040405
- Conditions
- Obesity, Reduced Lung Compliance., Anesthesia., Laparoscopy.
- Keywords
- Obesity., Respiration. Respiration, artificial., Ventilation. Pressure controlled. Volume controlled.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jun 2005
- First posted
- 23 Sep 2005 (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.
To assess the potential benefits on mechanical ventilation plateau pressure of pressure controlled mode versus volume controlled mode for laparoscopic bariatric surgery in obese patients (BMI > 35). High plateau pressures encountered in obese patients due to their reduced pulmonary compliance could be lowered using pressure controlled mechanical ventilation.
Detailed description
All patients are over 18 years old and give their inform consent after approval of the study protocol by an ethic committee. Anesthesia is standardized and all patients are intubated. Precise protocols are used to perform pressure and volume controlled ventilation in order to regulate End-Tidal CO2 between 33 and 35 mmHg. Primary goal is comparison of plateau pressures observed in the 2 ventilation modes after 45 minutes of pneumoperitoneum. Secondary goals are : comparison of PaO2 and PaCO2 after 45 minutes of pneumoperitoneum and after 2 hours spent in post-anesthesia care unit ; comparison of total respiratory resistances and peak flow generated between the 2 modes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients are over 18 years old and give their inform consent
- morbid obesity(BMI>35)
- laparoscopic bariatric surgery
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Mechanical Ventilation | Procedure or surgery | – |
Primary outcome
Plateau pressures generated by mechanical ventilation after 45 minutes of pneumoperitoneum.
1 secondary outcome
Comparison of PaO2 and PaCO2 after 45 minutes of pneumoperitoneum and after 2 hours spent in post-anesthesia care unit ; comparison of total respiratory resistances and peak flow generated between the 2 modes.
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 13 Apr 2006.
- Background: PubMed 12707159Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.
Related trials for Obesity
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
Philippe CADI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Ventilation in people with Obesity and Reduced Lung Compliance., run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 1 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 13 Apr 2006. 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 France. 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?
Plateau pressures generated by mechanical ventilation after 45 minutes of pneumoperitoneum.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00224653, which also lists 1 linked publication.
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 13 Apr 2006.