NCT00224653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2005

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
Last Updated

April 13, 2006

Status Verified

September 1, 2005

First QC Date

September 16, 2005

Last Update Submit

April 12, 2006

Conditions

ObesityReduced Lung Compliance.Anesthesia.Laparoscopy.

Keywords

Obesity.Respiration. Respiration, artificial.Ventilation. Pressure controlled. Volume controlled.

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Mechanical VentilationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georges Pompidou European Hospital

Paris, Île-de-France Region, 75908 cedex 15, France

Location

Related 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):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.

    PMID: 12707159BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Philippe CADI, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 23, 2005

Study Start

January 1, 2005

Study Completion

June 1, 2005

Last Updated

April 13, 2006

Record last verified: 2005-09

Locations

FR(1)