Clinical Significance of Alveolar Recruitment Maneuver Du... | NCT02592226

Studies
Clinical Significance of Alveolar Recruitment Maneuver During Bariatric Surgery

NCT02592226

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Jun 16, 2026Actual

Enrollment

230Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Anesthesia: alveolar recruitment maneuver
Anesthesia: standardized

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2015Actual

Primary Completion Date

Dec 14, 2017Actual

Completion Date

Dec 20, 2017Actual

First Submitted Date

Oct 29, 2015

First Submission Date that Met QC Criteria

Oct 29, 2015

First Posted Date

Oct 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Active Comparator		Procedure: Anesthesia: standardized
Protocol Group	Experimental		Procedure: Anesthesia: alveolar recruitment maneuver

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anesthesia: alveolar recruitment maneuver	Procedure		Protocol Group
Anesthesia: standardized

Measure	Description	Time Frame
occurrence of dyspnea		2 hours
oxygen saturation		2 hours

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mathilde SEVERAC, Dr	Centre Hospitalier Universitaire de Nice	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nice		Nice		06003	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33137453	Result	Severac M, Chiali W, Severac F, Perus O, Orban JC, Iannelli A, Debs T, Gugenheim J, Raucoules-Aime M. Alveolar recruitment manoeuvre results in improved pulmonary function in obese patients undergoing bariatric surgery: a randomised trial. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100775. doi: 10.1016/j.accpm.2020.09.011. Epub 2020 Nov 1.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases