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Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery

NCT03438383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-12-16

Study results available
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Summary

The effect of biphasic positive airway pressure (Bi-PAP) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible placebo device-related effects (sham-Bi-PAP) were investigated.

Conditions

  • Atelectasis
  • Pulmonary Infection
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Pulmonary Disease
  • Hypoxemic Respiratory Failure
  • Hypoxemia
  • Morbid Obesity

Interventions

DEVICE

Bi-PAP

The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.

DEVICE

Sham Bi-PAP

Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.

Sponsors & Collaborators

  • Elpis General Hospital

    collaborator UNKNOWN

  • Sotiria General Hospital

    collaborator OTHER

  • Evgenidion Hospital

    collaborator UNKNOWN

  • Evangelismos Hospital

    lead OTHER

Principal Investigators

  • Konstantinos Louis, MD, PhD · Dpt of ObGyn, Konstantopoulio-Patision Hospital, Greece

  • Konstantinos Roditis, MD, MSc · Dpt of Vascular Surgery, Korgialenio-Benakio HRC Hospital, Greece

  • Aikaterini N. Alexandropoulou, MD, PhD · Anaesthesiology Dpt, Evangelismos Hospital, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-23
Primary Completion
2012-05-22
Completion
2012-05-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03438383 on ClinicalTrials.gov