Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT03438383|
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atelectasis Pulmonary Infection COPD Pulmonary Disease Hypoxemic Respiratory Failure Hypoxemia Morbid Obesity||Device: Bi-PAP Device: Sham Bi-PAP||Not Applicable|
In the present study the effect of Bi-PAP on the postoperative respiratory function and related complications of MOP undergoing OBS through a randomized sham-controlled design was investigated. Bi-PAP was applied at individualized pressures in order to optimize respiratory support and sham Bi-PAP was also used in order to neutralize possible placebo device related effect and researcher related bias.
The investigators hypothesized that the use of Bi-PAP at individualized pressures in MOP undergoing OBS, ameliorates postoperative respiratory function as well as diminishes related pulmonary complications, postoperative pain and duration of hospitalization. Primary endpoints were the difference in pre- and postoperative measurements of certain pulmonary function parameters (FEV1, FVC, PEFR and SpO2) and the incidence of certain pulmonary complications postoperatively (hypoxemia, atelectasis, lower respiratory tract infections). Secondary endpoints were postoperative pain and days of hospitalization.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Patients were assigned into the following two study groups postoperatively:
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||May 23, 2011|
|Actual Primary Completion Date :||May 22, 2012|
|Actual Study Completion Date :||May 31, 2012|
Sham Comparator: Sham Bi-PAP
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
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.
Active Comparator: Bi-PAP
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
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.
- FEV1 difference [ Time Frame: 24 h before surgery and at 24, 48 and 72 h post-operatively ]difference in FEV1 value measured by spirometry pre- and post-operatively
- FVC difference [ Time Frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively ]difference in FVC value measured by spirometry pre- and post-operatively
- PEFR difference [ Time Frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively ]difference in PEFR value measured by spirometry pre- and post-operatively
- SpO2 difference [ Time Frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively ]difference in SpO2 value measured by spirometry pre- and post-operatively
- hypoxemia [ Time Frame: At 24, 48 and 72 hours post-operatively ]occurrence of hypoxemia, considered as SpO2<90%, post-operatively
- atelectasis [ Time Frame: At 24, 48 and 72 hours post-operatively ]occurrence of atelectasis as defined by CXR post-operatively with CXR before surgery as baseline
- post-operative pain [ Time Frame: right before spirometry, at 24, 48 and 72 h post-operatively ]Intensity of pain was assessed post-operatively by NRS scale (Numerical Rating Scale 0-10, 0=no pain, 10=worst pain imaginable)
- days of hospitalization [ Time Frame: Through study completion, an average of 1 year ]duration of hospitalization, calculated by discharge date minus admittance date
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438383
|Study Director:||Konstantinos Louis, MD, PhD||Dpt of ObGyn, Konstantopouleio-Patision General Hospital, Nea Ionia, Greece|
|Study Chair:||Konstantinos Roditis, MD, MSc||Dpt of Vascular Surgery, Korgialeneio-Benakeio General Hospital of the Hellenic Red Cross, Athens, Greece|
|Principal Investigator:||Aikaterini N. Alexandropoulou, MD, PhD||Anaesthesiology Dpt, Evangelismos General Hospital, Athens, Greece|