Continuous Positive Air Way Pressure in Cardiac Rehabilitation After CABG

• Sponsor: Riphah International University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05044559
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.5
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-cardiac Surgery	Other: Continuous Positive Air Way Group; Other: Control Group	N/A

Detailed Description

The walking time (6 minute walk test), effect on arterial blood gasses and long term effects of CPAP on cardiac activity, the previous studies focus only on the acute effects of CPAP along with specific exercises but did not tell about the long term effects. based on these finding this study is design to assess the effectiveness of CPAP in Post-op CABG patients regarding there early mobilization, walking time, ABGs and Ejection Fraction as there prognostic parameters in both phase-1 cardiac rehabilitation within hospital as well as in long-term prognosis, is of great interest.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Continuous Positive Airway Pressure in Phase 1 Cardiac Rehabilitation After Post CABG
• Actual Study Start Date: Jul 15, 2019
• Actual Primary Completion Date: Feb 27, 2020
• Actual Study Completion Date: Feb 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Continuous Positive Air Way Group 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; CPAP between 10 and 12 cmH2O
Active Comparator: Control Group 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; 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.

Outcome Measures

Primary Outcome Measures

1. Arterial Blood Gasses [3 days]

   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.

Secondary Outcome Measures

1. 6 minute walk test [3 days]

   gold standard test to measure exercise capacity and requires less physical space and allows for easier monitoring of vital parameters

2. Ejection Fraction [4 week]

   expressed as a percentage, of how much blood the left ventricle pumps out with each contraction.

3. Short Form 12 Questionnaire [4 weeks]

   measuring tool for mental and physical health components. It consists of 12 questions which cover the eight health domain with one or two question per domain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age between 35 to 60 years.

• With a clinical diagnosis of coronary artery disease, underwent elective CABG (Acute)

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwest General Hospital and research center	Peshawar	KPK	Pakistan

Sponsors and Collaborators

• Riphah International University

Investigators

• Principal Investigator: Sumaiyah Obaid, MS, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT05044559
• Other Study ID Numbers: REC/00593 Memoona Salal
• First Posted: Sep 14, 2021
• Last Update Posted: Sep 21, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Riphah International University: Continuous Positive Airway Pressure; Coronary Artery Bypass Graft Surgery; Inpatients Rehabilitations

Study Results

No Results Posted as of Sep 21, 2021