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Comparison of BiPAP and ٰIS in Reducing Post CABG Pulmonary Complications

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ClinicalTrials.gov Identifier: NCT04700215
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Muhammad Imran Khan, Chaudhry Pervaiz Elahi Institute of Cardiology

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

Condition or disease Intervention/treatment Phase
Pulmonary Complications Device: BiPAP Device: Incentive spirometry Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Effectiveness of Bilevel Positive Airway Pressure and Incentive Spirometry in Reducing Post CABG Surgery Pulmonary Complications
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : June 20, 2022
Estimated Study Completion Date : August 30, 2022
Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Post CABG pulmonary complications [ Time Frame: 06 months ]
    To see the effect of BiPAP and IS in reducing post CABG pulmonary complications


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT04700215


Contacts
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Contact: Muhammad Imran Khan +923326366121 imrkhan803@gmail.com
Contact: Muhamma Imran I khan, MBBS +923326366121 imrkhan803@gmail.com

Locations
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Pakistan
CPEIC Recruiting
Multān, Punjab, Pakistan, 66000
Contact: Muhammad Imran Khan, MBBS    +923326366121    imrkhan803@gmail.com   
Sponsors and Collaborators
Chaudhry Pervaiz Elahi Institute of Cardiology
Investigators
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Principal Investigator: Muhammad Imran Khan, MBBS Chaudhry Pervaiz Elahi Institute of Cardiology
More Information
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Responsible Party: Muhammad Imran Khan, Doctor Muhammad Imran Khan, Chaudhry Pervaiz Elahi Institute of Cardiology
ClinicalTrials.gov Identifier: NCT04700215    
Other Study ID Numbers: No.01-2020/ED/CPEIC/MULTAN
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Muhammad Imran Khan, Chaudhry Pervaiz Elahi Institute of Cardiology:
CABG
BiPAP
IS