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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04307316
Other study ID # REC/00423 Nouman Hussain
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2018
Est. completion date December 20, 2019

Study information

Verified date March 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to determine the effects of Active cycle of breathing technique (ACBT) on cardiopulmonary parameters of post CABG patients. A randomized control trial was conducted with a sample size of 40 post CABG patients. Non probability Convenience Sampling Technique was used to collect sample and randomization was done through sealed envelope method to allocate participants to the groups. Patients in experimental group did ACBT along with the conventional treatment protocol that was performed in the control group. Subjects completed the exercise protocol of 5 days. Both male and female post CABG patients of age 30-65 years who were vitally stable were included in study. Data was analyzed on Statistical Package for the Social Sciences (SPSS) version 21. Normality was assessed through shapiro wilk test. Parametric tests were applied on normally distributed variables and non parametric tests were applied for the non normally distributed data. Confidence interval was kept at 95% and p value <0.05 was considered significant.


Description:

Coronary artery bypass graft (CABG) is a surgery in which new routes are created around narrow and blocked coronary arteries, that allow proper flow of blood to provide oxygen and nutrients to the heart muscles. The grafts used in CABG can be a vein from lower extremity or any artery of chest. CABG is a surgery in which obstructed coronary arteries are replaced with autologous arteries and veins used as implant, which are fully or moderately congested by atherosclerotic plaque. ACBT is a method used to clear out the secretion from the chest. The purpose of ACBT treatment is to remove secretions from the chest that helps to reduce the frequency of infection, which control the additional airway impairment and worsening the lungs functions that may help in reducing the rate of progress of lung disease. After CABG surgery respiratory therapy is used rationally to inhibit the post-operative complications. Respiratory physiotherapy is routinely used in the prevention and treatment of post-operative pulmonary complications after cardiac surgery. The ultimate goal of physiotherapy in CABG patient is to improve increase lung volume, prevent atelectasis, enhance ventilation-perfusion matching, to increase sputum clearance, and decrease pain. ACBT technique can perform independently by patient with about applying manual technique. ACBT is very effective to improve oxygen saturation, control respiratory rate, and chest clearance after major surgeries. The efficiency of ACBT treatment has been checked out in stable cystic fibrosis, Chronic obstructive pulmonary disease and abdominal surgery. However, there is limited literature related to its use in patients after CABG surgery. The purpose of this research was to examine the effect of ACBT versus conventional chest physiotherapy after CABG surgery.

In 2018 a study was conducted on effect of ACBTs in post coronary artery bypass grafting patient and he concluded that ACBTs technique is a better way of treatment in coronary artery bypass grafting surgery patients. The determination of this research was to calculate the effectiveness of ACBT in CABG surgery patients. In this study total 15 patients were involved. All the patients were checked out by visual analogue scale for pain, 6-minute walk test (6MWT) for endurance and chest expansion was also measured. It concluded that chest expansion and 6MWT was improved in both groups.

ACBT is an effective technique implemented by the patient to secrete out the sputum from the main airway. The ACBT technique is combined breathing maneuvers to advance the efficiency of cough, untie and clear the secretions and increase the ventilation.

In 2016 a study was conducted observed the effects of ACBTs in post CABG surgery patients and The ACBTs treatment decrease the intensity of pulmonary impairments in post abdominal surgery.There is limited data available in support of effects of ACBTs on pulmonary functions after CABG surgery.

In 2015 a study was conducted to evaluate the effects of ACBTs on chest expansion, arterial blood gases, oxygen saturation, blood pressure, respiratory rate and other vitals in Chronic Obstructive Pulmonary disease (COPD) patients during 1st phase of cardiac rehab after CABG surgery. It concluded that ACBT are much effective than routine physiotherapy protocol in patients who have gone under coronary artery bypass grafting.

The present study is intended to observe the effects of ACBT on pulmonary function including lung volumes and capacities, chest expansion as well as the vitals of post operative CABG patients undergoing phase 1 cardiac rehabilitation.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 20, 2019
Est. primary completion date February 20, 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:

- Vitally stable post CABG patients

Exclusion Criteria:

- Hemodynamically unstable patients

- Patient after re-opening of sternum.

- Infected patients

- Patients who cannot speak Urdu, Punjabi or English language.

Study Design


Related Conditions & MeSH terms

  • Coronary Artery Bypass Graft Surgery

Intervention

Other:
ACBT group
ACBT: Breathing control 3 to 4 Thoracic Expansion Exercise A: 3 seconds hold B: Chest clapping C: Chest vibration Forced Expiratory Technique Breathing control A: 3 seconds hold B: Chest clapping C: Chest vibration 3 to 4 Thoracic Expansion Exercise Breathing control 1-2 Huff combine with breathing control Huff and cough Chest Physical Therapy Early mobilization
Conventional Physical therapy
Chest percussion, deep breathing, Huff and cough. Early mobilization

Locations

Country Name City State
Pakistan Riphah International University Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

Bachar BJ, Manna B. Coronary Artery Bypass Graft. 2019 May 17. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507836/ — View Citation

Filbay SR, Hayes K, Holland AE. Physiotherapy for patients following coronary artery bypass graft (CABG) surgery: limited uptake of evidence into practice. Physiother Theory Pract. 2012 Apr;28(3):178-87. doi: 10.3109/09593985.2011.582231. Epub 2011 Aug 8. — View Citation

Freitas ER, Soares BG, Cardoso JR, Atallah ÁN. Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD004466. doi: 10.1002/14651858.CD004466.pub3. Review. — View Citation

Hue B, Pelhate M, Callec JJ, Chanelet J. Synaptic transmission in the sixth ganglion of the cockroach: action of 4-aminopyridine. J Exp Biol. 1976 Dec;65(3):517-27. — View Citation

Lewis LK, Williams MT, Olds TS. The active cycle of breathing technique: a systematic review and meta-analysis. Respir Med. 2012 Feb;106(2):155-72. doi: 10.1016/j.rmed.2011.10.014. Epub 2011 Nov 18. Review. — View Citation

Renault JA, Costa-Val R, Rosseti MB, Houri Neto M. Comparison between deep breathing exercises and incentive spirometry after CABG surgery. Rev Bras Cir Cardiovasc. 2009 Apr-Jun;24(2):165-72. — View Citation

Thybo Karanfil EO, Møller AM. Preoperative inspiratory muscle training prevents pulmonary complications after cardiac surgery - a systematic review. Dan Med J. 2018 Mar;65(3). pii: A5450. Review. — View Citation

Üzmezoglu B, Altiay G, Özdemir L, Tuna H, Süt N. The Efficacy of Flutter(®) and Active Cycle of Breathing Techniques in Patients with Bronchiectasis: A Prospective, Randomized, Comparative Study. Turk Thorac J. 2018 Jul;19(3):103-109. doi: 10.5152/TurkThoracJ.2018.17050. Epub 2018 Jun 12. — View Citation

Zanini M, Nery RM, de Lima JB, Buhler RP, da Silveira AD, Stein R. Effects of Different Rehabilitation Protocols in Inpatient Cardiac Rehabilitation After Coronary Artery Bypass Graft Surgery: A RANDOMIZED CLINICAL TRIAL. J Cardiopulm Rehabil Prev. 2019 Nov;39(6):E19-E25. doi: 10.1097/HCR.0000000000000431. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Forced Expiratory Volume in 1 second (FEV1) Forced Expiratory Volume in 1 second (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal. After 5days
Primary Forced vital capacity (FVC) Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal. After 5days
Primary FEV1/FVC FEV1/FVC measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65). After 5days
Primary Peak expiratory flow rate (PEFR) Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings. After 5days
Primary Chest expansion Chest expansion at xiphoid level measured by finding the difference in measurements during inhalation and exhalation. After 5 days
Secondary Heart rate Heart rate is measured as part of vitals through heart rate monitor. After 5days
Secondary Respiratory rate Respiratory rate as part of vitals standing at bedside of the patients After 5 days
Secondary Systolic and diastolic blood pressure Blood pressure is measured through sphygmomanometer After 5days
Secondary Oxygen Saturation (SPO2) Oxygen saturation measured through pulse oximeter as part of vitals After 5days
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