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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
Sponsor:
Collaborators:
Elpis General Hospital
Sotiria General Hospital
Evgenidion Hospital
Information provided by (Responsible Party):
Alexandropoulou N. Aikaterini, Evangelismos Hospital

Brief Summary:
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) were investigated.

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

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients were assigned into the following two study groups postoperatively:

  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.
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. hypoxemia [ Time Frame: At 24, 48 and 72 hours post-operatively ]
    occurrence of hypoxemia, considered as SpO2<90%, post-operatively

  6. 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


Secondary Outcome Measures :
  1. 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)

  2. days of hospitalization [ Time Frame: Through study completion, an average of 1 year ]
    duration of hospitalization, calculated by discharge date minus admittance date



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients have been Morbidly Obese (BMI> 40kg/m2) for at least 10 years
  • All patients had unsuccessfully tried to lose weight by other non-invasive means.
  • All patients enrolled were 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:

  • Cardiovascular and pulmonary disease not related to obesity status
  • 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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Evangelismos Hospital
Elpis General Hospital
Sotiria General Hospital
Evgenidion Hospital
Investigators
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

Publications:

Responsible Party: Alexandropoulou N. Aikaterini, Consultant, Evangelismos Hospital
ClinicalTrials.gov Identifier: NCT03438383     History of Changes
Other Study ID Numbers: 142/23-05-2011
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Alexandropoulou N. Aikaterini, Evangelismos Hospital:
Bi-PAP
BiPAP
morbid obesity
anesthesia
bariatric surgery
sham Bi-PAP
sham BiPAP
postoperative complications

Additional relevant MeSH terms:
Lung Diseases
Respiratory Insufficiency
Obesity, Morbid
Hypoxia
Pulmonary Atelectasis
Respiratory Tract Diseases
Respiration Disorders
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Signs and Symptoms, Respiratory