| CTRI Number |
CTRI/2025/03/082393 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Measuring severity of diffculty in daily life activity in patients at 3 months post intensive care unit discharge using WHODAS2.0 |
|
Scientific Title of Study
|
Assessment of severity of disability in patients at 3 months post intensive care unit discharge using WHODAS2.0 Questionnaire: a prospective observational 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 |
Sachith Raju |
| Designation |
Senior resident |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Main ICU, BLOCK A, Nehru hospital, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8978861056 |
| Fax |
|
| Email |
Sachith.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeru Sahni |
| Designation |
Additional Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anaesthesia & Intensive care, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872646106 |
| Fax |
|
| Email |
neerunalin@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeru Sahni |
| Designation |
Additional Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anaesthesia & Intensive care, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872646106 |
| Fax |
|
| Email |
neerunalin@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of medical education and research,chandigarh,India,160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate institute of medical education and research |
| Address |
Anaesthesia and intensive care office , 5th floor,nehru building block A,Chandigarh,india,160012. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 P Sachith raju |
Medical ICU, post graduate institute of medical education. |
Chandigarh,India,160012
Chandigarh
CHANDIGARH |
8978861056
sachith.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post graduate institute of medical education and research, chandigarh, institute ethics committee,intramural |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z736||Limitation of activities due to disability, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (≥18 years) who have been discharged from the ICU after a stay of at least 48 hours. |
|
| ExclusionCriteria |
| Details |
Patients with pre-existing severe disabilities, patients who refuse to participate and patients who expire in ICU, hospital or before 3 months of ICU discharge. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the severity of disability in patients at 3 months post ICU discharge using the WHODAS 2.0 questionnaire |
3 months post discharge from Intensive Care Unit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To asses the severity of disability in patients at 6 months post ICU discharge using the WHODAS 2.0 questionnaire.
2.Association between post ICU disability at 3 months and admission diagnosis,acute physiology and chronic health evaluation 2 score in first 24hrs of admission,clinical fraility scale ,nutritional risk in critically ill score, charlson comorbidity index, episodes of hospital acquired infection, requirement of renal replacement theraphy, vasopressor support, days of mechanical ventilation, length of ICU stay, hospital length of stay, premorbid metabolic equivalent of task |
6months post ICU discharge |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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)
|
15/04/2025 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Primary purpose of this study is to assess the severe of disability at 3 months post ICU discharge as the fraility was observed high post icu discharge which affects the daily activity and functional outcomes of the patient, but no roboust study is conducted in india to support these findings and post icu discharge fraility acessment can help in planning inhospital interventions to reduce fraility |