NCT04700215

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

January 6, 2021

Last Update Submit

March 8, 2022

Conditions

Keywords

CABGBiPAPIS

Outcome Measures

Primary Outcomes (1)

  • Post CABG pulmonary complications

    To see the effect of BiPAP and IS in reducing post CABG pulmonary complications

    06 months

Study Arms (2)

Group 01 Effectiveness of BiPAP in reducing post CABG pulmonary complications

ACTIVE COMPARATOR

Bilevel positive airway pressure device after every 6 hours

Device: BiPAP

Group 02 Effectiveness of IS in reducing post CABG pulmonary complications

ACTIVE COMPARATOR

Incentive spirometry for 15 minutes after every 4 hours

Device: Incentive spirometry

Interventions

BiPAPDEVICE

To give bilevel positive airway pressure to the lungs

Also known as: Bilevel
Group 01 Effectiveness of BiPAP in reducing post CABG pulmonary complications

IS for 15 minutes after every 4 hours

Group 02 Effectiveness of IS in reducing post CABG pulmonary complications

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPEIC

Multan Khurd, Punjab Province, 66000, Pakistan

RECRUITING

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Muhammad Imran Khan, MBBS

    Chaudhry Pervaiz Elahi Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Imran Khan

CONTACT

Muhamma Imran I khan, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Muhammad Imran Khan

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 7, 2021

Study Start

March 1, 2021

Primary Completion

June 20, 2022

Study Completion

August 30, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations