| CTRI Number |
CTRI/2026/02/103350 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to See Whether Lung Flute Helps Improve Clear Chest Mucus and Breathing After Heart Valve Surgery |
|
Scientific Title of Study
|
Effect of lung flute on airway clearance and respiratory function in cardiac valve replacement surgery: A Randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gogula Mohana Sreya |
| Designation |
Student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Cardiovascular and Pulmonary Physiotherapy Department Room No. 6, Nehru Nagar, Belagavi, Karnataka-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8520827852 |
| Fax |
|
| Email |
gogulamohanasreya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Naik |
| Designation |
Associate Professor, Department of Cardiovascular and Pulmonary Physiotherapy |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Cardiovascular and Pulmonary Physiotherapy Department Room No. 6, Nehru Nagar, Belagavi, Karnataka-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9986497065 |
| Fax |
|
| Email |
varunnaik@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Gogula Mohana Sreya |
| Designation |
Student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Cardiovascular and Pulmonary Physiotherapy Department Room No. 6, Nehru Nagar, Belagavi, Karnataka-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8520827852 |
| Fax |
|
| Email |
gogulamohanasreya@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of Physiotherapy, Nehru nagar, Belagavi-590010 |
|
|
Primary Sponsor
|
| Name |
GOGULA MOHANA SREYA |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Cardiovascular and Pulmonary Physiotherapy Department Room No. 6, Nehru Nagar, Belagavi, Karnataka-590010
Belgaum
KARNATAKA
590010
India |
| Type of Sponsor |
Other [Self sponsored] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gogula Mohana Sreya |
KLE Institute of physiotherapy |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre, Room No. 39 Department of Cardiovascular and Pulmonary Physiotherapy, Room No.6, Nehru Nagar, Belagavi, Karnataka-590010
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
8520827852
gogulamohanasreya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics Committee, KAHER Institute of Physiotherapy, Belagavi. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post Valve Replacement surgery |
| Patients |
(1) ICD-10 Condition: I39||Endocarditis and heart valve disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional chest physiotherapy |
Active cycle of breathing technique(ACBT)
Deep breathing exercises
Segmental breathing
Diaphragmatic breathing
Incentive spirometry
Patient education
Frequency: Twice daily sessions for 5 days with total session for 30 minutes
. |
| Intervention |
Lung flute |
Device: Lung Flute
Frequency: Twice daily sessions for 5 days
Duration: 10 minutes per session. Total session takes 30 minutes
Session starts from day 3 till day 7.
Procedure:
Patient seated comfortably and Instructed to exhale through the Lung Flute.
Followed by coughing or huffing to expel loosened secretions.
Combined with Acute Phase cardiac rehabilitation components: deep breathing, limb exercises, incentive spirometry, and Patient education. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants who underwent valve replacement surgery.
Willingness to participate in the intervention and provide informed consent.
Individuals of both the genders aged between 40-70 years will be included in the study.
Hemodynamically stable. |
|
| ExclusionCriteria |
| Details |
Participants who underwent CABG.
Postoperative complications such as re-intubation.
Systematic infection, Active tuberculosis, pleural effusion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sputum metrics(volume in ml and colour)
Respiratory function:Incentive spirometer, Pulse oximeter |
Sputum metrics:- Pre intervention day 1(baseline) and post intervention on day 5.
Respiratory function: Incentive spirometer, Pulse oximeter. will be measured all 5 days pre and post treatment. on day 1 pre intervention as a baseline.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| New York Heart Association (NYHA) Functional Classification. |
The outcome will be measured on day 1 pre intervention(baseline) & day 5 post intervention. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the effectiveness of the lung flute as an adjunct to conventional chest physiotherapy in improving airway clearance and respiratory function in patients undergoing cardiac valve replacement surgery. Post operative patients are at high risk of pulmonary complications such as atelectasis and retained secretions due to general anesthesia, mechanical ventilation, and reduced chest expansion, A total 40 hemodynamically stable patients aged 40-70 years will be recruited and randomly allocated into two groups: a control group receiving conventional chest physiotherapy and an experimental group receiving Lung flute along with standard postoperative care. Interventions will be administered twice daily during the acute postoperative phase. Outcome measures include sputum metrics(volume and color) , respiratory parameters assessed using incentive spirometer and pulse oximeter, and functional capacity measured by NYHA functional classification. The study aims to determine whether the lung flute provides additional benefits in enhancing airway clearance and respiratory recovery following valve replacement surgery. |