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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pulmonary Complications

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