| CTRI Number |
CTRI/2024/11/076186 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Physiotherapy ICU Treatment for liver transplant recipient patient |
|
Scientific Title of Study
|
Intensive care physiotherapy treatment for liver transplant recipient patient |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidhi Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology Jaipur |
| Address |
Neuro Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology Jaipur
Jaipur
RAJASTHAN
302017
India |
| Phone |
09530211310 |
| Fax |
|
| Email |
drvidhi@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naimish N Mehta |
| Designation |
Professor and Head Department of HPB Surgery and Liver Transplantation |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
6th Floor, Shri Ram Cancer Center, Mahatma Gandhi Medical College and Hospital, Jaipur
Jaipur
RAJASTHAN
302017
India |
| Phone |
9811350626 |
| Fax |
|
| Email |
dr.nmehta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naimish N Mehta |
| Designation |
Professor and Head Department of HPB Surgery and Liver Transplantation |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
6th Floor, Shri Ram Cancer Center, Mahatma Gandhi Medical College and Hospital, Jaipur
RAJASTHAN
302017
India |
| Phone |
9811350626 |
| Fax |
|
| Email |
dr.nmehta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Hospital, Jaipur |
|
|
Primary Sponsor
|
| Name |
Vidhi Gupta |
| Address |
Neuro Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Type of Sponsor |
Other [Self] |
|
|
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 Naimish N Mehta |
Mahatma Gandhi Hospital |
Liver Transplant ICU, SRCC 3rd Floor, Mahatma Gandhi Hospital, MGUMST, Jaipur
Jaipur
RAJASTHAN |
9811350626
dr.nmehta@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma GAndhi Medical College and Hospital, MGUMST, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z944||Liver transplant status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intensive care Physiotherapy Treatment |
We will include the patients in our study as soon as they arrive in the ICU just after LT, from their first session with the Physiotherapist to their transfer to the Private Ward or Discharge.
The protocol will be applied for the duration of stay in the ICU. All the vitals and medical reports will be monitored daily before treatment to assess any
exercise contraindications for patients. These involve Heart Rate, Blood Pressure, Respiratory
Rate, Temperature, SpO2, ABG analysis report, X-ray, and Doppler, will be documented and
recorded by the physiotherapist.
The Treatment will involve three Phases
Phase I: Ventilated and Intubated
Phase II: Extubated on Oxygen Support
Phase III: Ambulatory Phase
All these phases differ in days based on individual patient’s health condition. Usually, the ICU stay for liver transplant recipient patient is 15 days. Every Physiotherapy treatment will be given 6 days a week for 1 hour. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient underwent Liver transplant surgery (LDLT Recipients)
Patient hemodynamically stable
Patients referred for physiotherapy |
|
| ExclusionCriteria |
| Details |
Liver Donor Patients
Multiple organ transplant patients
Patients having other neurological, cardiovascular, and psychological conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Spirometry
PERME Intensive Care Unit Mobility Scale |
15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PERME Intensive Care Unit Mobility Scale |
7th day |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
06/11/2024 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Purpose of this study is to devise a complete chest and limb physiotherapy intervention for liver transplant recipient patients in ICU to promote early recovery and to evaluate its effectiveness. 15 liver transplant recipient patients fulfilling the Inclusion and exclusion criteria will be included in the study. These patients will receive physiotherapy intervention in three phases from the ventilatory to ambulatory phase till the patient remains admitted in the Liver ICU. The Data will be collected at the end of every phase and it will be statistically analyzed with appropriate tool. |