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Comparison of BiPAP and ٰIS in Reducing Post CABG Pulmonary Complications

C

Chaudhry Pervaiz Elahi Institute of Cardiology

Status

Unknown

Conditions

Pulmonary Complications

Treatments

Device: BiPAP
Device: Incentive spirometry

Study type

Interventional

Funder types

Other

Identifiers

NCT04700215
No.01-2020/ED/CPEIC/MULTAN

Details and patient eligibility

About

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

Full 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.

Enrollment

350 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

350 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Muhammad Imran Khan; Muhamma Imran I khan, MBBS

Data sourced from clinicaltrials.gov

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