- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02592226
Clinical Significance of Alveolar Recruitment Maneuver During Bariatric Surgery
The ventilation of the patient under general anesthesia is an old problem and extensively studied, especially in visceral surgery, higher risk of postoperative complications. Studies have recently shown the impact of a lung-protective ventilation in visceral surgery, however obese patients are often excluded, and alveolar recruitment maneuver has never been studied independently.
The investigators are conducting a randomized controlled prospective study to investigate the clinical value to achieve alveolar recruitment maneuver routinely in patients undergoing bariatric surgery.
The objective is to show the reduction in dyspnea, oxygen dependency: reflection of atelectasis and the incidence of postoperative complications.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nice, France, 06003
- CHU de Nice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients surgery for bariatric surgery (sleeve, gastric bypass, gastric banding ablation)
- planned surgery,
- ASA 1-2-3,
Exclusion Criteria:
- Severe COPD
- Severe emphysema,
- Pneumothorax,
- Right sided heart failure,
- Severe heart failure
- Emergency surgery,
- ASA 4
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
|
|
|
Experimental: Protocol Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
occurrence of dyspnea
Time Frame: 2 hours
|
2 hours
|
|
oxygen saturation
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
Investigators
- Study Director: Mathilde SEVERAC, Dr, Centre Hospitalier Universitaire de Nice
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-PP-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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