| CTRI Number |
CTRI/2020/10/028243 [Registered on: 06/10/2020] Trial Registered Prospectively |
| Last Modified On: |
05/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Inspiratory muscle training device in Organo Phosphorus Poisoning Patients |
|
Scientific Title of Study
|
Effect of Threshold Inspiratory Muscle Training Device in Extubated Organophosphorus Poisoning Patients: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishnu Vardhan |
| Designation |
Associate Professor |
| Affiliation |
Dr.A.P.J.Abdul Kalam College of Physiotherapy,Pravara Institute of Medical Sciences |
| Address |
Dr.A.P.J.Abdul Kalam College of Physiotherapy,Pravara Institute of Medical Sciences,Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8379917421 |
| Fax |
|
| Email |
vishnudiwakarpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu Vardhan |
| Designation |
Associate Professor |
| Affiliation |
Dr.A.P.J.Abdul Kalam College of Physiotherapy,Pravara Institute of Medical Sciences |
| Address |
Dr.A.P.J.Abdul Kalam College of Physiotherapy,Pravara Institute of Medical Sciences,Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8379917421 |
| Fax |
|
| Email |
vishnudiwakarpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishnu Vardhan |
| Designation |
Associate Professor |
| Affiliation |
Dr.A.P.J.Abdul Kalam College of Physiotherapy,Pravara Institute of Medical Sciences |
| Address |
Dr.A.P.J.Abdul Kalam College of Physiotherapy,Pravara Institute of Medical Sciences,Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8379917421 |
| Fax |
|
| Email |
vishnudiwakarpt@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pravara Institute of Medical Sciences |
| Address |
Pravara Institute of Medical Sciences,Ahmadnagar District,Rahata
Taluka ,loni,Maharashtra. |
| 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 Vishnu Vardhan |
Pravara Rural Hospital |
Dr.A.P.J.Abdul Kalam
college of
Physiotherapy,Loni.
Ahmadnagar
MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
8379917421
vishnudiwakarpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pravara Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T489||Poisoning by, adverse effect of and underdosing of other and unspecified agents primarily acting on the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diaphragmatic Breathing Exercises |
In Control Group,Diaphragmatic Breathing Exercises will be given for 10 minutes twice a day for 1 week.The patient will be seated in a comfortable position.
The patient will place both hands on the abdomen and is instructed to breathe in slowly through the nose so that the stomach expands and moves out against the patient’s hand |
| Intervention |
Threshold Inspiratory Muscle Training (IMT) Device |
In Experimental Group,the patient will inspire through the Threshold IMT device along with diaphragmatic breathing exercises will be given for 10 minutes twice a day for 1 week.Threshold IMT device is an inspiratory muscle trainer for muscle strength and endurance, are easy to set with adjustable pressure in cm H2O.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Extubated Organophosphorus Poisoning Patients
2.Both male and female participants
3.Age between 20 to 65 years
4.Ready to give written informed consent from the patient or relatives
|
|
| ExclusionCriteria |
| Details |
1.Participants who were haemodynamically unstable
2.Chronic debilitating conditions, rib fractures, thoracic vertebra fracture, acute pleuritic chest pain.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maximal Inspiratory Pressure (MIP) |
Before and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oxygen Saturation (SPo2) |
Before and after intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/10/2020 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"none yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The need of the study is to find out the efficacy of Threshold Inspiratory Muscle Training (IMT) device along with diaphragmatic breathing exercises on inspiratory muscle strength in extubated organophosphorous poisoning patients.Inspiratory muscle weakness are predominant in extubated organophosphorous poisoning patients.The objective of the study is to find the efficacy of Threshold IMT device on inspiratory muscle strength which will be measures by Maximal Inspiratory Pressure (MIP). |