Comparison of BiPAP and ٰIS in Reducing Post CABG Pulmonary Complications

March 8, 2022 updated by: Muhammad Imran Khan, Chaudhry Pervaiz Elahi Institute of Cardiology

Comparison of Effectiveness of Bilevel Positive Airway Pressure and Incentive Spirometry in Reducing Post CABG Surgery Pulmonary Complications

To evaluate the effect of Bi-level Positive Airway Pressure (BiPAP) and Incentive Spirometry (IS) in post CABG patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

As postoperative pulmonary complications are major concern in cardiac surgery patients and our local data is deficient for making better management guidelines. My study aims to provide a base for future research on this dimension and to decide better management plan for post cardiac surgical pulmonary complications. The hypothesis is Post extubation BiPAP is more effective than Incentive Spirometry (IS) in reducing postoperative pulmonary complications in cardiac surgical patients and the purpose of the study is to evaluate the effect of Bi-level Positive Airway Pressure (BiPAP) and Incentive Spirometry (IS) in cardiac surgical patients.

This Randomized Controlled Trial (RCT) study will be conducted at Chaudhary pervaiz elahi institute of cardiology ICU multan.

A sample size of 350 patients will be taken and effect of BiPAP and Incentive spirometry will be studied in reducing pulmonary complications post CABG surgery. Data will be analyzed through SPSS. For quantitative variables, mean and standard deviation will be calculated and for qualitative variables, frequency and percentage will be calculated. Chi square test will be used to estimate association between qualitative variables. A p value < 0.05 will be significant.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Multān, Punjab, Pakistan, 66000
        • Recruiting
        • CPEIC
        • Contact:

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

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CABG patients
  • Patient willing to study
  • Patients planned for on-pump cardiac surgical procedures
  • Both genders (Male & Female)
  • Age 20-60 years
  • Ejection fraction 40-60%

Exclusion Criteria:

  • Patients with valvular lesions
  • Off-pump cardiac surgery
  • Refusal to give consent for BiPAP
  • Emergency surgery
  • Previous cardiac surgery
  • Obesity BMI>30
  • ASA status V

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 01 Effectiveness of BiPAP in reducing post CABG pulmonary complications
Bilevel positive airway pressure device after every 6 hours
Device: BiPAP
To give bilevel positive airway pressure to the lungs
Other Names:
  • Bilevel
ACTIVE_COMPARATOR: Group 02 Effectiveness of IS in reducing post CABG pulmonary complications
Incentive spirometry for 15 minutes after every 4 hours
Device: Incentive spirometry
IS for 15 minutes after every 4 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post CABG pulmonary complications
Time Frame: 06 months
To see the effect of BiPAP and IS in reducing post CABG pulmonary complications
06 months

Collaborators and Investigators

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

Sponsor

Chaudhry Pervaiz Elahi Institute of Cardiology

Investigators

  • Principal Investigator: Muhammad Imran Khan, MBBS, Chaudhry Pervaiz Elahi Institute of Cardiology

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)

March 1, 2021

Primary Completion (ANTICIPATED)

June 20, 2022

Study Completion (ANTICIPATED)

August 30, 2022

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 6, 2021

First Posted (ACTUAL)

January 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • No.01-2020/ED/CPEIC/MULTAN

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

No

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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