An interventional study of Conventional Chest Physiotherapy and Flutter device with conventional chest physiotherapy in Peak Expiratory Flow Rate, Coronary Artery Bypass Graft Surgery and Chronic Obstructive Pulmonary Disease, sponsored by Foundation University Islamabad. Recruiting at 1 site in Pakistan. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Treatment
Flutter therapy is an oscillating positive expiratory pressure (OPEP) technique that combines positive expiratory pressure with airway oscillations to facilitate mobilization and clearance of respiratory secretions. Conventional chest physiotherapy includes deep breathing exercises, incentive spirometry, airway-clearance techniques, splinted coughing and early mobilization to promote lung expansion and secretion clearance. A total of 94 patients aged 40-70 years with mild-to-moderate COPD undergoing elective coronary artery bypass grafting (CABG) will be enrolled in this randomized controlled trial and will be randomly allocated into two groups, with 47 participants in each group. The intervention group will receive conventional chest physiotherapy combined with Flutter therapy, while the control group will receive conventional chest physiotherapy alone. Both groups will receive supervised treatment for 5 consecutive postoperative days, with 3 sessions per day, resulting in 15 treatment sessions. Baseline assessment will be performed on postoperative day 1 before commencement of the intervention, and post-intervention assessment will be conducted on postoperative day 5. The study will compare the effects of Flutter-assisted conventional chest physiotherapy versus conventional chest physiotherapy alone on postoperative peak expiratory flow rate, chest expansion and airway clearance.
Chronic obstructive pulmonary disease (COPD) is associated with persistent respiratory symptoms, airflow limitation and increased mucus secretion and retention. Patients undergoing coronary artery bypass grafting (CABG) are also at risk of developing postoperative pulmonary complications. The co-existence of COPD may further affect the postoperative respiratory recovery and airway clearance. Conventional chest physiotherapy (CPT) is commonly used in the postoperative management of CABG patients to facilitate lung expansion, improve ventilation and promote Airway clearance. Flutter therapy is an oscillating positive expiratory pressure (OPEP) technique that combines positive expiratory pressure with airway oscillations and is used to facilitate mobilization and airway clearance. The present randomized controlled trial is designed to investigate the additional effects of Flutter therapy when combined with CPT in post-CABG patients with COPD. A total of 84 participants will be included in the study and randomly allocated into two groups. Group A will serve as the control group and will receive CPT alone. Group B will serve as the intervention group and will receive CPT in combination with Flutter therapy. Selection of subjects will be done by using non-probability purposive sampling technique. The sample size was calculated using G* power software version 3.1. Normality testing will be done by using Shapiro-Wilk Test. Based on the normality test, difference within groups will be determined using paired t-test (Wilcoxon Signed Rank) whereas difference between two groups will be determined using independent t-test (Mann Whitney U). Data will be analyzed using SPSS v. 21.0. The intervention will be administered for five consecutive days during the postoperative period. Three treatment sessions will be provided each day, resulting in a total of 15 treatment sessions for each participant. Participants in the control group will receive CPT according to the study protocol whereas in the intervention group will receive the same CPT program with the addition of Flutter therapy. The treatment procedures will be administered according to the predefined study protocol throughout the intervention period. The study assessments will be performed according to the specified assessment schedule. Assessment will be conducted before the intervention and after completion of the five-day treatment period. The outcome assessor will be blinded to the group allocation. This blinding will be maintained during assessment to minimize potential assessment bias between the control and intervention groups. The study will therefore provide a comparison between CPT alone and CPT with Flutter therapy in post-CABG patients with COPD. The comparison is intended to determine the additional effects associated with incorporating Flutter therapy into CPT during the postoperative treatment period. The study will focus on the changes observed following the specified treatment program and will provide evidence regarding the additional role of Flutter therapy as an adjunct to CPT in this patient population. All study procedures will be conducted in accordance with the predefined study protocol. Data generated during the study will be recorded systematically and analyzed according to the statistical procedures specified in the research protocol.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 84 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
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Exclusion Criteria:
Participants allocated to Group A (control group) will receive conventional chest physiotherapy during the early postoperative period following CABG. The intervention will comprise deep breathing exercises, incentive spirometry, airway-clearance techniques, splinted coughing and early mobilization. Treatment will be administered under supervision for 5 consecutive postoperative days, with 3 sessions per day, resulting in a total of 15 treatment sessions. The techniques will be performed according to the standardized study protocol and adapted to the participant's postoperative clinical status and tolerance
Procedure: Conventional Chest Physiotherapy
Participants allocated to Group B (intervention group) will receive conventional chest physiotherapy combined with Flutter therapy during the early postoperative period following CABG. Flutter therapy will be administered as an adjunct to conventional chest physiotherapy using an oscillating positive expiratory pressure (OPEP) device to facilitate airway secretion clearance. Treatment will be supervised for 5 consecutive postoperative days, with 3 sessions per day, resulting in a total of 15 sessions. The intervention will be adapted according to the participant's postoperative clinical status and tolerance.
Device: Flutter device with conventional chest physiotherapy
1. Diaphragmatic Breathing Description: Slow deep breathing emphasizing diaphragmatic movement performed for10 repetitions × 3 sets per session. 2. Incentive Spirometry Description: Sustained maximal inspiration using an incentive spirometer 10 repetitions × 3 sets per session. 3. Chest Percussion Description: Rhythmic clapping of the chest wall with a cupped, 02-03 minutes on Day 1, 03-05 minutes on Days 2-5. 4. Splinted Coughing Description: Controlled coughing with support to the surgical incision using a pillow or hands to facilitate secretion clearance while minimizing discomfort as needed/occasional during the session. 5. Early Mobilization Description: Gradual progression of physical activity during the postoperative period, including sitting, standing and ambulation, as tolerated. A 05-day protocol will be followed.
Flutter therapy will be administered as an adjunct to conventional chest physiotherapy using a portable, oscillating positive expiratory pressure (OPEP) device, for 3 sessions per day for 5 consecutive postoperative days.
Peak Expiratory Flow Rate
Peak expiratory flow rate will be assessed using a peak flow meter. Three expiratory trials will be performed, and the highest recorded value will be documented in liters per minute (L/min).
Time frame: 5 days
Chest Expansion
Measured using measuring tape at the axillary, mid thoracic/sternal, and xiphoid levels by recording chest circumference at inspiration and expiration.
Time frame: 5 days
Total Expectorated Sputum Volume (mL)
Airway clearance will be assessed by measuring the total volume of expectorated sputum collected, recorded in milliliters (mL). Sputum volume will be recorded during the five-day assessment period.
Time frame: 5 days
Dyspnea
Dyspnea will be assessed using the Modified Borg Scale to quantify the participant's perceived intensity of breathlessness. The participants will rate their perceived level of dyspnea using the scale at the specified assessment time points.
Time frame: 5 days
Breathlessness, Cough and Sputum Scale (BCSS) Total Score
Respiratory symptom severity will be assessed using the Breathlessness, Cough and Sputum Scale (BCSS), a three-item questionnaire evaluating breathlessness, cough, and sputum symptoms. Each item is scored from 0 to 4, giving a total score ranging from 0 to 12. A score of 0 indicates no symptoms, whereas higher total scores indicate greater respiratory symptom severity and a worse outcome.
Time frame: 5 days
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
Of 796 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 10 months is below that.
Counting every sponsor, half of 848 studies reached it within 24 months; a quarter within 11 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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