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

November 25, 2020 updated by: Alexandropoulou N. Aikaterini, Evangelismos Hospital

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 (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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 centimeter of water (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume at One Second (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
24 h before surgery and at 24, 48 and 72 h post-operatively
Forced Vital Capacity (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
24 h before surgery and at 24, 48 and 72 hours post-operatively
Peak Expiratory Flow Rate (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
24 h before surgery and at 24, 48 and 72 hours 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
24 h before surgery and at 24, 48 and 72 hours post-operatively
Number of Participants With Hypoxemia
Time Frame: At 24, 48 and 72 hours post-operatively
occurrence of hypoxemia, considered as SpO2<90%, post-operatively
At 24, 48 and 72 hours post-operatively
Number of Participants With Atelectasis
Time Frame: At 24, 48 and 72 hours post-operatively
occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline
At 24, 48 and 72 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Pain
Time Frame: right before spirometry, at 24, 48 and 72 h post-operatively
Intensity of pain was assessed post-operatively by Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable)
right before spirometry, at 24, 48 and 72 h post-operatively
Days of Hospitalization
Time Frame: From day of admission to day of discharge from the hospital
duration of hospitalization, calculated by discharge date minus admission date
From day of admission to day of discharge from the hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evangelismos Hospital

Collaborators

Sotiria General Hospital
Elpis General Hospital
Evgenidion Hospital

Investigators

  • Study Director: Konstantinos Louis, MD, PhD, Dpt of ObGyn, Konstantopoulio-Patision Hospital, Greece
  • Study Chair: Konstantinos Roditis, MD, MSc, Dpt of Vascular Surgery, Korgialenio-Benakio HRC Hospital, Greece
  • Principal Investigator: Aikaterini N. Alexandropoulou, MD, PhD, Anaesthesiology Dpt, Evangelismos Hospital, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 23, 2011

Primary Completion (ACTUAL)

May 22, 2012

Study Completion (ACTUAL)

May 31, 2012

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 16, 2018

First Posted (ACTUAL)

February 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 142/23-05-2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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