| CTRI Number |
CTRI/2025/04/083820 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Mechanical Vibration device to clear Airways In ICU: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effects of Mechanical Chest Wall Vibrator for Bronchial Hygiene In Intensive Care Unit: 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 |
Dr Varun Naik |
| Designation |
MPT PhD Associate Professor, Department of cardiovascular and pulmonary physiotherapy, |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Dr. Prabhakar Kore Hospital and MRC,
Advanced Physiotherapy Center room no 39, Department of Cardiovascular and pulmonary physiotherapy room no 6, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9986497065 |
| Fax |
|
| Email |
varunnaik@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Naik |
| Designation |
MPT PhD Associate Professor, Department of cardiovascular and pulmonary physiotherapy, |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Dr. Prabhakar kore Hospital and MRC, Advanced Physiotherapy Center room no 39, Department of Cardiovascular and Pulmonary Physiotherapy room no 6, Nehru Nagar, Belagavi.
Dr. Prabhakar kore Hospital and MRC, Advanced physiotherapy Center, Department of Cardiovascular and pulmonary physiotherapy room no 6, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9986497065 |
| Fax |
|
| Email |
varunnaik@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anushka amit Kulkarni |
| Designation |
MPT PG 1 Department of cardiovascular and pulmonary physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Dr. Prabhakar kore Hospital and MRC,
Advanced physiotherapy Center room no 39, Department of cardiovascular and pulmonary physiotherapy room no 6, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9986497065 |
| Fax |
|
| Email |
anushkakulkarni20302@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Dr. Prabhakar Kore Hospital and MRC,
Advanced Physiotherapy Center, Department of Cardiovascular and Pulmonary Physiotherapy room no 6, Nehru Nagar, Belagavi, Karnataka,590010 |
|
|
Primary Sponsor
|
| Name |
KLE institute of physiotherapy |
| Address |
Dr. Prabhakar Kore Hospital and MRC,
Advanced Physiotherapy Center, Department of cardiovascular and Pulmonary Physiotherapy room no 6, Nehru Nagar, Belagavi, Karnataka 590010 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrVarun Naik |
KLE Prabhakar Kores Hospital |
Sagar floor, Advanced
physiotherapy Center
room No 39 Dr
Prabhakar kore
Hospital and MRC,
Nehru Nagar, Belagavi,
KARNATAKA 590010
Belgaum
KARNATAKA |
9986497065
varunnaik@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
manual percussion |
Subjects will be randomly allocated to groups A (interventional group) and B (control group) using the envelope method.
Group A:- intervention will be given after 24 hrs of admission, and the procedure for Group A involves performing manual chest physiotherapy to enhance bronchial hygiene in ICU patients. The therapy is conducted twice daily for 15 minutes over five days, with a frequency of 100 to 120 cycles per minute. The session begins with manual percussion using cupped hands on the chest wall, targeting specific lung segments, followed by gentle manual vibrations, particularly during exhalation. Intercostal stretches are performed by gently pulling the rib cage laterally and anteriorly, lasting 1 minute. A basal lift technique is applied by placing hands under the lower rib cage to facilitate lung expansion. Finally, suctioning is performed to clear any mobilized secretions, ensuring the patient’s respiratory status is monitored throughout the procedure. |
| Intervention |
mechanical chest wall vibrator |
the procedure for Group B involves using a mechanical chest wall vibration device in ICU patients. This therapy is administered twice daily for 15 minutes for five days, operating at a frequency of 60 Hz. The session begins with the mechanical vibrator applied to the chest wall, delivering consistent vibrations to help mobilize secretions. Following this, intercostal stretches are performed by gently pulling the rib cage laterally and anteriorly to promote lung expansion for 1 to 2 minutes. A basal lift technique is applied, where the therapist places hands under the lower rib cage to facilitate further lung expansion. Finally, suctioning is conducted to clear any mobilized secretions, ensuring that the patient’s respiratory status is closely monitored throughout the procedure. This structured approach aims to improve lung function and reduce the risk of respiratory complications in mechanically ventilated patients.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between Age group 18–75 years for all the genders.
Intubated patients in ICU.
Participants on invasive mechanical ventilatory support for more than 48hrs
|
|
| ExclusionCriteria |
| Details |
patients with any history of Seizures.
Open Thoracic Wounds
coagulation disorder
Subjects with Rib or Sternum Fracture.
Spinal Trauma.
Pulmonary Embolism
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. ABG analysis
pH
pao2
paCO2
HCO3
oxygen saturation
2. Ventilatory parameters
positive end expiratory pressure
tidal volume
inspiratory : expiratory ratio
FiO2
|
before the intervention and post-intervention i.e. 5days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of Intubation in days.
2.Length of stay in ICU in days.
monitoring parameters-
respiratory rate
heart rate
spo2
blood pressure
|
monitoring parameters - daily for 5 days pre and post intervention. |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| Date of Study Completion (India) |
01/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study investigates the effects of mechanical chest wall vibrators on bronchial hygiene in patients in the Intensive Care Unit (ICU). Mechanical ventilation is critical for patients with respiratory failure, but it can lead to complications such as ventilator-associated pneumonia (VAP) and other pulmonary issues. Effective bronchial hygiene is essential to prevent these complications. AIMS-To compare and evaluate the effects of a mechanical chest wall vibrator for bronchial hygiene in patients in the Intensive Care Unit. OBJECTIVE - To determine and compare the effects of mechanical chest wall vibrators with conventional physiotherapy on bronchial hygiene in patients admitted to Intensive Care Unit using ABG analysis and Ventilator parameters.
|