Comparison Between Volume Controlled Ventilation and Pressure Controlled Ventilation

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT00224653
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 7.3

Study Details

Study Description

Brief 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). High plateau pressures encountered in obese patients due to their reduced pulmonary compliance could be lowered using pressure controlled mechanical ventilation.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Reduced Lung Compliance.; Anesthesia.; Laparoscopy.	Procedure: Mechanical Ventilation	N/A

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

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2005
• Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

1. Plateau pressures generated by mechanical ventilation after 45 minutes of pneumoperitoneum. []

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

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.

• ClinicalTrials.gov Identifier: NCT00224653
• Other Study ID Numbers: P040405; PS040405
• First Posted: Sep 23, 2005
• Last Update Posted: Apr 13, 2006
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: Obesity.; Respiration. Respiration, artificial.; Ventilation. Pressure controlled. Volume controlled.
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Apr 13, 2006