Clinical Significance of Alveolar Recruitment Maneuver During Bariatric Surgery

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592226
• Other study ID #: 15-PP-11
• Status: Completed
• Phase: N/A
• First received: October 29, 2015
• Last updated: April 18, 2017
• Start date: November 2015

Study information

• Verified date: October 2015
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Anesthesia: alveolar recruitment maneuver

• Anesthesia: standardized

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of dyspnea		2 hours
Primary	oxygen saturation		2 hours