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Comparison Between Volume Controlled Ventilation and Pressure Controlled Ventilation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00224653
First Posted: September 23, 2005
Last Update Posted: April 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Obesity Reduced Lung Compliance. Anesthesia. Laparoscopy. Procedure: Mechanical Ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Plateau pressures generated by mechanical ventilation after 45 minutes of pneumoperitoneum.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 36
Study Start Date: January 2005
Estimated Study Completion Date: June 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients are over 18 years old and give their inform consent
  • morbid obesity(BMI>35)
  • laparoscopic bariatric surgery

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224653


Locations
France
Georges Pompidou European Hospital
Paris, Ile de France, France, 75908 cedex 15
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe CADI, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00224653     History of Changes
Other Study ID Numbers: P040405
PS040405
First Submitted: September 16, 2005
First Posted: September 23, 2005
Last Update Posted: April 13, 2006
Last Verified: September 2005

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Obesity.
Respiration. Respiration, artificial.
Ventilation. Pressure controlled. Volume controlled.