Monitoring Lung Recruitment Maneuver in Anesthetized Morbidly Obese

Atelectasis Clinical Trial

Official title:

Non-invasive Assessment of Lung Recruitment in Morbid Obese Patients Undergoing Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694665
• Other study ID #: HPC-
• Status: Completed
• Phase: N/A
• Start date: September 11, 2016
• Est. completion date: May 17, 2018

Study information

• Verified date: August 2018
• Source: Hospital Privado de Comunidad de Mar del Plata
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 17, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atelectasis
• Pulmonary Atelectasis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Argentina	Hospital Privado de Comunidad	Mar del Plata	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Privado de Comunidad de Mar del Plata

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the optimum positive end-expiratory pressure in anesthetized morbidly obese patients	Comparison between a reference method (esophageal balloon) with volumetric capnography.	intraoperative