Comparison of BiPAP and ٰIS in Reducing Post CABG Pulmonary Complications

Not Applicable

• Conditions: Pulmonary Complications
• Interventions: Device: Incentive spirometry; Device: BiPAP

• Registration Number: NCT04700215
• Lead Sponsor: Chaudhry Pervaiz Elahi Institute of Cardiology

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Study Start: 2021-03-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09
• Primary Completion: 2022-06-20
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 02 Effectiveness of IS in reducing post CABG pulmonary complications	Incentive spirometry	Incentive spirometry for 15 minutes after every 4 hours
Group 01 Effectiveness of BiPAP in reducing post CABG pulmonary complications	BiPAP	Bilevel positive airway pressure device after every 6 hours

Primary Outcome Measures

Name	Time	Method
Post CABG pulmonary complications	06 months	To see the effect of BiPAP and IS in reducing post CABG pulmonary complications

Trial Locations

Locations (1)

CPEIC; 🇵🇰 Multān, Punjab, Pakistan