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CompletedNCT03694665Updated Feb 22, 2019

Monitoring Lung Recruitment Maneuver in Anesthetized Morbidly Obese

An interventional study of Lung recruitment maneuver in Atelectasis, sponsored by Hospital Privado de Comunidad de Mar del Plata. Completed at 1 site in Argentina. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-22.

Sponsored by Hospital Privado de Comunidad de Mar del Plata · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Atelectasis

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Keywords

  • airways pressure
  • mechanical ventilation
  • Atelectasis
03

In context

Pulmonary Atelectasis

301 studies on the registry are indexed under Pulmonary Atelectasis; 80 are open to participants now.

This study's enrollment of 30 is below the median of 61 across 222 interventional studies indexed under Pulmonary Atelectasis.

Browse Pulmonary Atelectasis studies →

Lead sponsor

Hospital Privado de Comunidad de Mar del Plata is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Acute pulmonary disease
  • Emergency surgery
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    Morbidly anesthetized obese

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

    Other: Lung recruitment maneuver

Interventions

  • OtherLung 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.

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What researchers measure

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.

    Time frame: intraoperative

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Study locations

1 site
  • Hospital Privado de Comunidad
    Mar del Plata, Buenos Aires 7600, Argentina
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03694665
Lead sponsor
Hospital Privado de Comunidad de Mar del Plata
Responsible party
Sponsor
First posted
Oct 3, 2018
Start date
Sep 11, 2016
Primary completion
Mar 1, 2018
Completion
May 17, 2018
Last update
Feb 22, 2019

Study contacts

Gerardo Tusman, MD
principal investigator · Hospital Privado de Comunidad

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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