Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery
NCT ID: NCT03438383
Last Updated: 2020-12-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2011-05-23
2012-05-31
Brief Summary
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Detailed Description
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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 (forced expiratory volume at one second (FEV1), forced vital capacity (FVC), peak expiratory flow rate (PEFR) and oxygen saturation by pulse oximetry (SpO2) and the incidence of certain pulmonary complications postoperatively (hypoxemia, atelectasis, lower respiratory tract infections). Secondary endpoints were postoperative pain and days of hospitalization.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
1. Sham Bi-PAP (control group) group in which sham Bi-PAP was applied through nasal mask for 3 days postoperatively.
2. Bi-PAP group in which Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively.
1 patient was initially enrolled in the protocol but was excluded from the participant flow design because of recent onset of cardiovascular disease (CAD).
TREATMENT
NONE
Study Groups
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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 centimeter of water (cm H2O).
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* All patients had unsuccessfully tried to lose weight by other non-invasive means.
* All patients enrolled were continuous positive airway pressure (CPAP) and Bi-PAP naïve and had no knowledge about the Bi-PAP apparatus prior to enrollment
* All patients underwent OBS (gastroplasty by Mason or gastric bypass) by the same operating team
* All patients were treated with the same standard anesthetic protocol
Exclusion Criteria
* Chronic renal disease
* Patients who were initially enrolled but did not use the allocated device (Bi-PAP or Sham Bi-PAP) for at least 12 h daily were also excluded at a later point.
ALL
No
Sponsors
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Elpis General Hospital
UNKNOWN
Sotiria General Hospital
OTHER
Evgenidion Hospital
UNKNOWN
Evangelismos Hospital
OTHER
Responsible Party
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Alexandropoulou N. Aikaterini
Consultant
Principal Investigators
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Konstantinos Louis, MD, PhD
Role: STUDY_DIRECTOR
Dpt of ObGyn, Konstantopoulio-Patision Hospital, Greece
Konstantinos Roditis, MD, MSc
Role: STUDY_CHAIR
Dpt of Vascular Surgery, Korgialenio-Benakio HRC Hospital, Greece
Aikaterini N. Alexandropoulou, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Anaesthesiology Dpt, Evangelismos Hospital, Greece
References
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Related Links
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Publication of Study Results
Other Identifiers
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142/23-05-2011
Identifier Type: -
Identifier Source: org_study_id