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NCT04700215 Clinical Trial

Comparison of BiPAP and ٰIS in Reducing Post CABG Pulmonary Complications

Pulmonary Complications Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04700215
Other study ID # No.01-2020/ED/CPEIC/MULTAN
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date August 30, 2022

Study information
Verified date March 2022
Source Chaudhry Pervaiz Elahi Institute of Cardiology
Contact Muhammad Imran Khan
Phone +923326366121
Email imrkhan803@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 350
Est. completion date August 30, 2022
Est. primary completion date June 20, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• BiPAP
To give bilevel positive airway pressure to the lungs
• Incentive spirometry
IS for 15 minutes after every 4 hours

Locations
Country Name City State
Pakistan CPEIC Multan Punjab

Sponsors (1)
Lead Sponsor Collaborator
Chaudhry Pervaiz Elahi Institute of Cardiology

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post CABG pulmonary complications To see the effect of BiPAP and IS in reducing post CABG pulmonary complications 06 months
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