| CTRI Number |
CTRI/2024/10/075180 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PERSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Social and Economic problem of ICU survivors identified by structured follow up critical care clinic |
|
Scientific Title of Study
|
Socioeconomic problems of Intensive Care Unit survivors identified by structured follow up critical care clinic a prospective observation 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 |
Namrata Shukla |
| Designation |
Post Graduate Student |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesiology and Critical care, Near gate no. 2, King George Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9532490816 |
| Fax |
|
| Email |
namsdgreat16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ahsan Khaliq Siddiqui |
| Designation |
Additional Professor |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesiology and Critical care, Near gate no. 2, King George Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7052228963 |
| Fax |
|
| Email |
aksiddiqui@kgmcindia.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ahsan Khaliq Siddiqui |
| Designation |
Additional Professor |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesiology and Critical care, Near gate no. 2, King George Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7052228963 |
| Fax |
|
| Email |
aksiddiqui@kgmcindia.edu |
|
|
Source of Monetary or Material Support
|
| Intensive Care Unit, King George Medical University Lucknow, India, 226003 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Chowk, Lucknow, 226003, Uttar Pradesh |
| Type of Sponsor |
Government 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 |
| Namrata Shukla |
King George Medical University, Lucknow |
Department of Anaesthesiology and Critical Care, Near gate no. 2, Chowk, Lucknow
Lucknow
UTTAR PRADESH |
9532490816
namsdgreat16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, King George Medical University, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either gender.
ICU stay for more than 72 hours. |
|
| ExclusionCriteria |
| Details |
1.Non-willing patients.
2.Drop out respondents. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the social and economic problems faced by ICU survivors. |
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the 6 months mortality and unplanned hospital visits and readmission. |
180 days |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/11/2024 |
| 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="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
|
In this prospective observational study, total 96 patients will be enrolled as per inclusion-exclusion criteria. Patients after ICU discharge will be accessed in follow up OPD for the study ofSocial and Economic problems faced by them. We will also observe the 6 months mortality, unplanned hospital visits and readmission. We will assess every patient through these scale: 1. Assesses 10 basic ADL activities to produce a Oto 20 rating where Ois maximal disability and 20 is maximal independence. Activities of Daily Living (ADL) _ Assesses 8 ADL tasks, rating each on a O(unable) to 6 (maximal function) scale. 2. Emotional and Social Intelligence (ESI) is defined as a set of competencies demonstrating the ability one has to recognize their behaviors, moods, and impulses, and to manage them best according to situation. 3. Physical activity questionnaire. 4. Upgraded BG prasad scale. |