NCT02592226

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ 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

First Submitted

Initial submission to the registry

October 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

October 29, 2015

Last Update Submit

March 20, 2026

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • occurrence of dyspnea

    2 hours

  • oxygen saturation

    2 hours

Study Arms (2)

Control group

ACTIVE COMPARATOR
Procedure: Anesthesia: standardized

Protocol Group

EXPERIMENTAL
Procedure: Anesthesia: alveolar recruitment maneuver

Interventions

Anesthesia: alveolar recruitment maneuverPROCEDURE
Protocol Group
Anesthesia: standardizedPROCEDURE
Control group

Eligibility Criteria

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

You may qualify if:

  • Patients surgery for bariatric surgery (sleeve, gastric bypass, gastric banding ablation)
  • planned surgery,
  • ASA 1-2-3,

You may not qualify if:

  • Severe COPD
  • Severe emphysema,
  • Pneumothorax,
  • Right sided heart failure,
  • Severe heart failure
  • Emergency surgery,
  • ASA 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

Related Publications (1)

  • 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.

    PMID: 33137453RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mathilde SEVERAC, Dr

    Centre Hospitalier Universitaire de Nice

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

October 30, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2016

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

FR(1)