Home » Trials » SLCTR/2018/006


Randomised Controlled Trial on the effects of selected of positive expiratory pressure (PEP) breathing exercises with conventional breathing exercises in patients undergoing coronary artery bypass graft (CABG) surgery -

SLCTR Registration Number

SLCTR/2018/006


Date of Registration

02 Feb 2018

The date of last modification

Feb 02, 2018



Application Summary


Scientific Title of Trial

Randomised Controlled Trial on the effects of selected of positive expiratory pressure (PEP) breathing exercises with conventional breathing exercises in patients undergoing coronary artery bypass graft (CABG) surgery


Public Title of Trial

Comparison of the effects of different types of positive expiratory pressure (PEP) breathing exercises with conventional breathing exercises in patients undergoing coronary artery bypass graft (CABG) surgery in Sri Lanka


Disease of Health Condition(s) Studied

Post operative respiratory complications after CABG surgery


Scientific Acronym

None


Public Acronym

None


Brief title

Effectiveness of PEP exercises after CABG surgery


Universal Trial Number

U1111-1208-2939


Any other number(s) assigned to the trial and issuing authority

EC-16-215 (ERC: Colombo


Trial Details


What is the research question being addressed?

What are the effects of different types of positive expiratory pressure (PEP) breathing exercises when compared to conventional breathing exercises in patients undergoing coronary artery bypass graft (CABG) surgery?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose

Prevention


Purpose


Intervention(s) planned

Study setting: National Hospital Sri Lanka (NHSL)

All patients who admit for CABG surgery in Cardiothoracic Units of NHSL will be consecutively screened for eligibility. Following recruitment, participants will be assigned in to 03 (three) groups (group A, B and C) randomly using sealed envelopes containing the group number. All the patients will be allocated in the study until sample size (180) obtained.

Intervention: Participants in groups A and B will attend sessions of positive expiratory pressure (PEP) exercises by the principal investigator starting from 2 days before surgery. The exercises will be demonstrated and supervised individually by the principal investigator from pre-operative day 2 until discharge from the ward.

Participants of Group C will receive standard management only. All the three groups will continue routine physiotherapy techniques conducted by the ward physiotherapists.

Group A: Commercialized PEP device group (used to create an expiratory resistance of +10 cm of H2O). The patients will be instructed to perform the exercises in the sitting position. Subjects will be instructed to perform slow maximal inspirations, while expiration will be through the device. The exercise session will include 3 sets of 10 deep breaths with 30 to 60 seconds pause between each set per hour while awake.

Group B: PEP – Blow bottle device group. A bottle with 10 cm of water and a 42cm plastic tube (1 cm diameter) will be used as the blow bottle. The maneuver gives will provide a resisted exhalation with an expiratory peak pressure of 10cm H2O. Subjects will be instructed to perform slow maximal inspirations, while expiration through the device, in the sitting position. The exercise included 3 sets of 10 deep breaths with 30 to 60 seconds pause between each set per hour while awake.

Group C: Conventional group Participants will be encouraged to continue routine physiotherapy techniques conducted by the ward staff. They will not be taught any extra breathing exercises.

The routine protocol consists of deep breathing exercises, breathing exercises using an incentive volumetric spirometer associated, coughing and huffing techniques. All participants will be encouraged to continue these exercises hourly while awake.

The exercise programme will be monitored through direct observation twice a day by the principal investigator and by the patient training diary maintained hourly while awake during the hospital. The participants will take the personal device to home after discharge from hospital for home breathing exercises. All the participants (all three groups) will be requested to continue the exercises for one month after surgery at home which will be encouraged through two phone calls weekly and will be monitored with exercise diaries.


Inclusion criteria

Male and female patients between 40 to 70 years of age awaiting CABG surgery at NHSL


Exclusion criteria

Exclusion criteria at point of recruitment
1. Other cardiovascular surgical procedure other than CABG Had a myocardial infarction within the past five days
2. Unstable angina
3. Patients with previous open heart surgery
4. Patients with hemodynamic instability –Blood pressure (BP) less than 110-70 mmHg, Heart rate 100-60, sinus rhythm
5. Uncooperative patients
6. Inability to consent or understand
7. Cognitive impairment
8. Diagnosed with cerebrovascular, orthopedic, neurologic, or cognitive-emotive disorders that would prevent the completion of the pre-surgical test items
9. Patients with COPD and any respiratory conditions
10. Any contraindication to use of PEP therapy e.g. severe haemoptysis, pneumothorax

Exclusion criteria at point of analysis
11. ICU time > 72 hours
12. Depend on mechanical ventilator for more than 24 hours
13. Need balloon pump more than 24 hours
14. Need ionotropic support more than 3 days



Primary outcome(s)

Improvement of post-operative pulmonary function over baseline as determined by
1. Forced vital capacity (FVC)
2. Forced expiratory volume in 1st second(FEV1)
3. Vital Capacity (VC)


Primary outcome(s) - Time of assessment(s)

All primary outcomes will be measured
1. Three days before surgery- baseline data
2. One week after surgery
3. One month after surgery
4. Three months after surgery
5. Six months after surgery


Secondary outcome

  1. improvement of arterial oxygen saturation (SpO2) over baseline using pulse oximeter
  2. Improvement of hand grip strength (kg) over baseline using the Jammar hand held dynamometer
  3. Postoperative sternotomy incision pain using a 10 point numerical scale
  4. Quality of life using the SF36 questionnaire
  5. Assessment of exercise capacity using the 6 minute walk test

Secondary outcome(s) - Time of assessment(s)

All secondary outcomes will be measured
1. Three days before surgery- baseline data
2. One week after surgery
3. One month after surgery
4. Three months after surgery
5. Six months after surgery



Target number/sample size

Total number- 180: 60 patients will be recruited for each study group.Group A: commercialized PEP device group Group B: PEP blow bottle device group Group C: conventional group


Countries of recruitment

Sri Lanka


Anticipated start date

2018-03-01


Anticipated end date

2018-12-31


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee of Faculty of Medicine, Colombo for study titled Comparison of the effects of different types of positive expiratory pressure (PEP) breathing exercises with conventional breathing exercises in patients undergoing co


Funding source

University of Colombo (Small Research Grant no AP/3/2/2017/SG/12)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Ms. MDC Silva
Lecturer (Probationary)
Department of Physiotherapy, Faculty of Allied Health Sciences, General Sir John Kotelawala Defence University Werahera, Sri Lanka

Mob: 0783639478

denikach@gmail.com

Contact Person for Public Queries

Dr. PM Atapatthu
Senior Lecturer
Department of Physiology Faculty of Medicine, University of Colombo
Tel: +94112695300
Mob: +94779501610

piyushaatapattu@yahoo.com


Primary study sponsor/organization

University of Colombo

Cumaratunga Munidasa Mw Colombo 03 Sri Lanka
Tel: (+94) 112 581 835


http://www.cmb.ac.lk/

Secondary study sponsor (If any)

None