Monitoring Lung Recruitment Maneuver in Anesthetized Morbidly Obese

Not Applicable

Completed

• Conditions: Atelectasis
• Interventions: Other: Lung recruitment maneuver

• Registration Number: NCT03694665
• Lead Sponsor: Hospital Privado de Comunidad de Mar del Plata

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-08-01
• Study Start: 2016-09-11
• Primary Completion: 2018-03-01
• Study Completion: 2018-05-17
• Status Verified: 2018-08
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-03
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Measurement of the optimum positive end-expiratory pressure in anesthetized morbidly obese patients	intraoperative	Comparison between a reference method (esophageal balloon) with volumetric capnography.

Trial Locations

Locations (1)

Hospital Privado de Comunidad; 🇦🇷 Mar del Plata, Buenos Aires, Argentina