NCT03694665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 11, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
Last Updated

February 22, 2019

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

August 1, 2016

Last Update Submit

February 20, 2019

Conditions

Atelectasis

Keywords

airways pressuremechanical ventilationAtelectasis

Outcome Measures

Primary Outcomes (1)

  • Measurement of the optimum positive end-expiratory pressure in anesthetized morbidly obese patients

    Comparison between a reference method (esophageal balloon) with volumetric capnography.

    intraoperative

Study Arms (1)

Morbidly anesthetized obese

OTHER

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

Other: Lung recruitment maneuver

Interventions

Lung recruitment maneuverOTHER

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.

Morbidly anesthetized obese

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Acute pulmonary disease
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Gerardo Tusman, MD

    Hospital Privado de Comunidad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

October 3, 2018

Study Start

September 11, 2016

Primary Completion

March 1, 2018

Study Completion

May 17, 2018

Last Updated

February 22, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)