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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05936788
Other study ID # REC/RCR & AHS/23/0310
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2023
Est. completion date November 20, 2023

Study information

Verified date June 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the effects of active cycle of breathing technique and diaphragmatic breathing on pulmonary functions and sputum diary after coronary artery bypass graf


Description:

It will be a randomized clinical trial. Age of selected subjects will be between 40 to 60 years and data will be collected from intensive care units (ICUs) and cardiac care units (CCUs) of selected hospitals. There will be 2 groups i.e. group A will receive active cycle of breathing technique (ACBT) and group B will receive diaphragmatic breathing technique. Spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (BCSS) will be used to evaluate the improvement in sputum diary of patients. The trial will be completed in two days after patients admitted in the ICUs/CCUs and before and after each session, primary and secondary outcomes will be measured for both groups. After data collection, data will be analyzed using SPSS version 25


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date November 20, 2023
Est. primary completion date August 10, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Post-CABG patients - Gender: males and females - Have speaking, hearing and cognitive ability - On mechanical ventilation for = 24 h after CABG Exclusion Criteria: - Prior history of open heart surgery - Prior severe pulmonary/hepatic or renal disease- Complications after CABG (cardiogenic shock, bleeding requiring transfusion, acute kidney injury, cardiac temponade and severe hypotension) - Life-threatening arrhythmias (ventricular fibrillation, ventricular tachycardia, atrial fibrillation) - On mechanical ventilator for more than 24 h after CABG - Pulmonary complications (atelectasis, acute respiratory distress syndrome (ARDS), diaphragmatic injury)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Active cycle of breathing technique
Group A will receive ACBTs with 1 session a day for total 2 days in a week.
diaphragmatic breathing
Group B will receive diaphragmatic breathing for 1 session a day for total 2 days in a week.

Locations

Country Name City State
Pakistan Sadiq Saadiq hospital Gujranwala, DHQ hospital Gujranwala Gujranwala, Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Jasani N, Awad NT, Raut C. Effect of Coronary Artery Bypass Grafting Surgery on Pulmonary Function Tests and Arterial Blood Gases. Indian J Chest Dis Allied Sci. 2016 Jul;58(3):161-164. — View Citation

Montrief T, Koyfman A, Long B. Coronary artery bypass graft surgery complications: A review for emergency clinicians. Am J Emerg Med. 2018 Dec;36(12):2289-2297. doi: 10.1016/j.ajem.2018.09.014. Epub 2018 Sep 8. — View Citation

Moradian ST, Najafloo M, Mahmoudi H, Ghiasi MS. Early mobilization reduces the atelectasis and pleural effusion in patients undergoing coronary artery bypass graft surgery: A randomized clinical trial. J Vasc Nurs. 2017 Sep;35(3):141-145. doi: 10.1016/j.jvn.2017.02.001. — View Citation

Ono M, Serruys PW, Hara H, Kawashima H, Gao C, Wang R, Takahashi K, O'Leary N, Wykrzykowska JJ, Sharif F, Piek JJ, Garg S, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Noack T, Davierwala PM, Mohr FW, Cohen DJ, Onuma Y; SYNTAX Extended Survival Investigators. 10-Year Follow-Up After Revascularization in Elderly Patients With Complex Coronary Artery Disease. J Am Coll Cardiol. 2021 Jun 8;77(22):2761-2773. doi: 10.1016/j.jacc.2021.04.016. — View Citation

Rademacher J, Welte T. Bronchiectasis--diagnosis and treatment. Dtsch Arztebl Int. 2011 Dec;108(48):809-15. doi: 10.3238/arztebl.2011.0809. Epub 2011 Dec 2. — View Citation

Urell C, Westerdahl E, Hedenstrom H, Janson C, Emtner M. Lung Function before and Two Days after Open-Heart Surgery. Crit Care Res Pract. 2012;2012:291628. doi: 10.1155/2012/291628. Epub 2012 Aug 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 6 Min walk test The 6 min walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance.It is also use to monitor your response to treatments for heart lung and other health problems. Provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. 4 weeks
Secondary Borg Rating of Perceived scale Is a way of measuring physical activity intensity level.It has a range from 6 to 20 ,scale correlates with a person heart rate or how hard they feel they are working.Ask you to rate the difficulty of your breathing. 4 weeks
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