Clinical Significance of Alveolar Recruitment Maneuver During Bariatric Surgery

NCT ID: NCT02592226

Last Updated: 2017-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

Group Type ACTIVE_COMPARATOR

Anesthesia: standardized

Intervention Type PROCEDURE

Protocol Group

Group Type EXPERIMENTAL

Anesthesia: alveolar recruitment maneuver

Intervention Type PROCEDURE

Interventions

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Anesthesia: alveolar recruitment maneuver

Intervention Type PROCEDURE

Anesthesia: standardized

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathilde SEVERAC, Dr

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33137453 (View on PubMed)

Other Identifiers

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15-PP-11

Identifier Type: -

Identifier Source: org_study_id

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