Comparison Between Volume Controlled Ventilation and Pressure Controlled Ventilation

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224653
• Other study ID #: P040405
• Secondary ID: PS040405
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: April 12, 2006
• Start date: January 2005
• Est. completion date: June 2005

Study information

• Verified date: September 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients are over 18 years old and give their inform consent

• morbid obesity(BMI>35)

• laparoscopic bariatric surgery

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia.
• Laparoscopy.
• Obesity
• Reduced Lung Compliance.

Intervention

Procedure:
• Mechanical Ventilation

Locations

Country	Name	City	State
France	Georges Pompidou European Hospital	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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):1510-5, table of contents. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plateau pressures generated by mechanical ventilation after 45 minutes of pneumoperitoneum.
Secondary	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.