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NCT Number: NCT03438383

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

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.

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Key information

Conditions

Atelectasis Body Weight Chronic Disease Chronic Obstructive Pulmonary Disease (COPD) Disease Attributes Hypoxemia Hypoxemic Respiratory Failure Hypoxia Lung Diseases Lung Diseases, Obstructive Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Pulmonary Atelectasis Pulmonary Disease Pulmonary Disease, Chronic Obstructive Pulmonary Infection Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bi-PAP

Device

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

Device

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  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. Number of Participants With Hypoxemia

    Time frame: At 24, 48 and 72 hours post-operatively

    occurrence of hypoxemia, considered as SpO2<90%, post-operatively

  6. 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

Secondary outcomes

  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 Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable)

  2. 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

Sponsors and collaborators

Lead sponsor

Evangelismos Hospital

Other

Collaborators

  • Elpis General Hospital
  • Evgenidion Hospital
  • Sotiria General Hospital

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 19, 2018
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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