Comparison of BiPAP and ٰIS in Reducing Post CABG Pulmonary Complications

NCT ID: NCT04700215

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-08-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pulmonary Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Group 01 Effectiveness of BiPAP in reducing post CABG pulmonary complications

Bilevel positive airway pressure device after every 6 hours

Group Type ACTIVE_COMPARATOR

BiPAP

Intervention Type DEVICE

To give bilevel positive airway pressure to the lungs

Group 02 Effectiveness of IS in reducing post CABG pulmonary complications

Incentive spirometry for 15 minutes after every 4 hours

Group Type ACTIVE_COMPARATOR

Incentive spirometry

Intervention Type DEVICE

IS for 15 minutes after every 4 hours

Interventions

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BiPAP

To give bilevel positive airway pressure to the lungs

Intervention Type DEVICE

Incentive spirometry

IS for 15 minutes after every 4 hours

Intervention Type DEVICE

Other Intervention Names

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Bilevel

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chaudhry Pervaiz Elahi Institute of Cardiology

OTHER_GOV

Sponsor Role lead

Responsible Party

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Muhammad Imran Khan

Doctor Muhammad Imran Khan

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Imran Khan, MBBS

Role: PRINCIPAL_INVESTIGATOR

Chaudhry Pervaiz Elahi Institute of Cardiology

Locations

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CPEIC

Multan Khurd, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Muhammad Imran Khan

Role: CONTACT

+923326366121

Muhamma Imran I khan, MBBS

Role: CONTACT

+923326366121

Facility Contacts

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Muhammad Imran Khan, MBBS

Role: primary

+923326366121

Other Identifiers

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No.01-2020/ED/CPEIC/MULTAN

Identifier Type: -

Identifier Source: org_study_id

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