Monitoring Lung Recruitment Maneuver in Anesthetized Morbidly Obese

NCT ID: NCT03694665

Last Updated: 2019-02-22

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-11

Study Completion Date

2018-05-17

Brief Summary

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Morbid obese patients present changes in respiratory physiology caused by weight overload. Intraoperative atelectasis is a pulmonary complication that affects not only gas exchange but also respiratory mechanics. The present study was aimed to test the role of different parameters for monitoring the treatment of atelectasis by a lung recruitment maneuver.

Detailed Description

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This is a prospective study perform in 30 anesthetized morbidly obese undergoing bariatric surgery. Lung mechanics and volumetric capnography will be non-invasively assessed during laparoscopy. Esophageal pressure will be measured by an esophageal balloon to measure transpulmonary pressure. A lung recruitment maneuver will be done. The optimum level of positive end-expiratory pressure (PEEP) is defined as the PEEP level when transpulmonary pressure remains positive during the PEEP titration trial of the recruitment maneuver. Lung collapse is detected when transpulmonary pressure becomes negative. The behavior of the studied volumetric capnography and lung mechanics parameters will be compared with the reference transpulmonary pressure signal.

Conditions

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Atelectasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Morbidly anesthetized obese

Morbidly obese patients undergoing bariatric surgery (single-arm study) will receive a Lung recruitment maneuver to treat atelectasis..

Group Type OTHER

Lung recruitment maneuver

Intervention Type OTHER

A Lung recruitment maneuver is aimed to resolve atelectasis during mechanical ventilation. It consists in a brief and controlled increment in airways pressure using pressure control ventilation. Positive end-expiratory pressure (PEEP) is increases every 5 centimeters of water (cmH2O), from 0 to 20 cmH2O keeping a fixed driving pressure of 20 cmH2O. A final step of 40 cmH2O of plateau pressure was maintained for 10 breaths, returning then to standard ventilatory settings.

Interventions

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Lung recruitment maneuver

A Lung recruitment maneuver is aimed to resolve atelectasis during mechanical ventilation. It consists in a brief and controlled increment in airways pressure using pressure control ventilation. Positive end-expiratory pressure (PEEP) is increases every 5 centimeters of water (cmH2O), from 0 to 20 cmH2O keeping a fixed driving pressure of 20 cmH2O. A final step of 40 cmH2O of plateau pressure was maintained for 10 breaths, returning then to standard ventilatory settings.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) \> 40 kg/m2
* Written inform consent
* Scheduled for bariatric surgery
* American Society of Anesthesia physical status II-III

Exclusion Criteria

* Acute pulmonary disease
* Emergency surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Privado de Comunidad de Mar del Plata

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerardo Tusman, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Privado de Comunidad

Locations

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Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, Argentina

Site Status

Countries

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Argentina

Other Identifiers

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HPC-

Identifier Type: -

Identifier Source: org_study_id

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