CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Bi-PAP +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03438383
NCT03438383N/ACompleted
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The Effect of 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)

Evangelismos Hospital·interventional·Posted Feb 19, 2018·Updated Dec 16, 2020

In Brief

A clinical study evaluating Bi-PAP and Sham Bi-PAP for Atelectasis and 6 related conditions. Completed, enrolled 48 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtelectasis, Pulmonary Infection, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Disease, Hypoxemic Respiratory Failure, Hypoxemia, Morbid Obesity
Countries--
CollaboratorsElpis General Hospital, Sotiria General Hospital, Evgenidion Hospital

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2018
Enrollment StartMay 23, 2011
Primary CompletionMay 22, 2012
Study CompletionMay 31, 2012
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.4 years ago

Interventions

Bi-PAPdevice

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.

Sham Bi-PAPdevice

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.