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Monitoring Lung Recruitment Maneuver in Anesthetized Morbidly Obese

Primary Purpose

Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Lung recruitment maneuver
Sponsored by
Hospital Privado de Comunidad de Mar del Plata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atelectasis focused on measuring airways pressure, mechanical ventilation, Atelectasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Privado de Comunidad

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Morbidly anesthetized obese

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 1, 2016
Last Updated
February 20, 2019
Sponsor
Hospital Privado de Comunidad de Mar del Plata
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1. Study Identification

Unique Protocol Identification Number
NCT03694665
Brief Title
Monitoring Lung Recruitment Maneuver in Anesthetized Morbidly Obese
Official Title
Non-invasive Assessment of Lung Recruitment in Morbid Obese Patients Undergoing Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 11, 2016 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
May 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Privado de Comunidad de Mar del Plata

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
Keywords
airways pressure, mechanical ventilation, Atelectasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morbidly anesthetized obese
Arm Type
Other
Arm Description
Morbidly obese patients undergoing bariatric surgery (single-arm study) will receive a Lung recruitment maneuver to treat atelectasis..
Intervention Type
Other
Intervention Name(s)
Lung recruitment maneuver
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of the optimum positive end-expiratory pressure in anesthetized morbidly obese patients
Description
Comparison between a reference method (esophageal balloon) with volumetric capnography.
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerardo Tusman, MD
Organizational Affiliation
Hospital Privado de Comunidad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Privado de Comunidad
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No

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Monitoring Lung Recruitment Maneuver in Anesthetized Morbidly Obese

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