NCT05044559

Brief Summary

Different studies reported that CPAP is effective to prevent respiratory complication in post CABG patient and have greater impact on walking time, ventilatory function and breathing pattern.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

September 13, 2021

Last Update Submit

September 14, 2021

Conditions

Post-cardiac Surgery

Keywords

Continuous Positive Airway PressureCoronary Artery Bypass Graft SurgeryInpatients Rehabilitations

Outcome Measures

Primary Outcomes (1)

  • Arterial Blood Gasses

    measures oxygen and carbon dioxide levels in your blood. It also measures your body's acid-base (pH) level, which is normally balanced when you are healthy.

    3 days

Secondary Outcomes (3)

  • 6 minute walk test

    3 days

  • Ejection Fraction

    4 week

  • Short Form 12 Questionnaire

    4 weeks

Study Arms (2)

Continuous Positive Air Way Group

EXPERIMENTAL

Day 1: Use of CPAP between 10 and 12 cmH2O according to tolerance for 20 minutes two time a day at first day of post surgery bed mobility chest physiotherapy ,active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise. and vital was record after exercise. Day 2: Active ROM exercise progress of 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time was increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days.

Other: Continuous Positive Air Way Group

Control Group

ACTIVE COMPARATOR

Day 1: Bed mobility chest physiotherapy, active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise and vital was record after exercise. Day 2: Active range of motion exercise progress with 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time will increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days.

Other: Control Group

Interventions

Continuous Positive Air Way GroupOTHER

CPAP between 10 and 12 cmH2O

Continuous Positive Air Way Group
Control GroupOTHER

Day 1: Bed mobility chest physiotherapy, active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise and vital was record after exercise. Day 2: Active range of motion exercise progress with 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time will increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days.

Control Group

Eligibility Criteria

Age35 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsclinical diagnosis of coronary artery disease, underwent elective CABG (Acute)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 35 to 60 years.
  • With a clinical diagnosis of coronary artery disease, underwent elective CABG (Acute)

You may not qualify if:

  • Low ejection friction (15%)
  • Patient those who have any arrhythmias
  • Unstable angina
  • Patient having pace maker and implantable cardioverter defibrillator
  • COPD and asthmatic patient
  • Patient having BMI more then 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest General Hospital and research center

Peshawar, KPK, Pakistan

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sumaiyah Obaid, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 14, 2021

Study Start

July 15, 2019

Primary Completion

February 27, 2020

Study Completion

February 27, 2020

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)