| CTRI Number |
CTRI/2025/09/095207 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
New Breathing Trainer May Help Prevent Lung Issues After Abdominal Surgery |
|
Scientific Title of Study
|
Effect of the Tailor-Made Water Column Pressure Base Inspiratory Muscle Trainer (TMWCP-IMT) on Inspiratory Muscle Strength and to reduce postoperative pulmonary complications in patients undergoing Upper Abdominal Surgery - A Randomized Controlled Study. |
| 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 Hritika Pratap Malve |
| Designation |
MPT First year Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
Department of cardiovascular and respiratory physiotherapy Block 1
Basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy
MIDC Ahmadnagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8483931028 |
| Fax |
|
| Email |
hritikamalve24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit D Diwate |
| Designation |
HOD Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
Department of cardiovascular and respiratory physiotherapy Block 1
Basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy
MIDC Ahmadnagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8554990222 |
| Fax |
|
| Email |
abhijitdiwate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hritika Pratap Malve |
| Designation |
MPT First year Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
Department of cardiovascular and respiratory physiotherapy Block 1
Basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy
MIDC Ahmadnagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8483931028 |
| Fax |
|
| Email |
hritikamalve24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Vithal rao Vikhe Patil College Of Physiotherapy Ahmadnagar |
|
|
Primary Sponsor
|
| Name |
DVVPFs College Of Physiotherapy |
| Address |
DVVPFs College Of Physiotherapy Oppo Govt Milk Dairy MIDC Ahmadnagar |
| 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 |
| Dr Hritika Pratap Malve |
Dr Vikhe Patil Memorial Hospital,Ahilyanagar |
Dr Vikhe Patil Memorial Hospital
Vilad-ghat Oppo to Govt milk dairy Manmad road Ahilyanagar
Ahmadnagar
MAHARASHTRA |
8483931028
hritikamalve24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFS COPT INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J952||Acute pulmonary insufficiency following nonthoracic surgery. Ayurveda Condition: SALYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: 7 days protocal only twice a day )
| | 2 | Intervention Arm | Procedure | - | | (Procedure Reference: Mestriner, R. G, Procedure details: 7 days protocol only twice a day)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants are willing to participate.
2.Patients with elective upper abdominal surgery.
3.Both male and female
4.Patient with stable hemodynamics
5.American Association of Anesthesiology (ASA) Grade 1 & 2.
Grade 1 -A normal healthy patient (non- smoking or minimal alcohol)
Grade 2 – A patient with mild systemic diseases (without functional limitations)
|
|
| ExclusionCriteria |
| Details |
1.Subject with pre diagnosed respiratory pathology.
2.Subject who has a history of smoking.
3.Subject already diagnosed with any neuromuscular disease which directly affects the lung functions.
4. Subject on drugs which will suppress or affect the outcome measures, e.g. bronchodilators. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Vital Parameters
2.Maximum Inspiratory Pressure (Inspiratory muscle strength)
|
1 times on the day of recruitment and on the 7th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PFT lung function – (FEV1, FVC, FEV1/FVC & PEFR). |
1 times on the day of recruitment and on 7th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study aims to study the effect
of the Tailor-Made Water Column Pressure Base Inspiratory Muscle Trainer
(TMWCP-IMT on inspiratory muscle
strength and to reduce postoperative pulmonary complications in patients
undergoing Upper Abdominal Surgery. 30 patients will be recruited based on the inclusion and exclusion criteria of the study. After the recruitment, a verbal and written informed consent form will be obtained. All the basic demographic information will be documented, following outcome measures like Maximal Inspiratory Pressure & Pulmonary Function Test will
be taken at baseline of i.e. on 2nd day and at the end of the
protocol i.e. 7th day. Data will be
collected & will be statistically analyzed and results will be analyzed. |