| CTRI Number |
CTRI/2025/04/084896 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Early screening of Acute Stress after ICU discharge using PCL5 questionnaire |
|
Scientific Title of Study
|
Assessment of incidence of acute stress disorder and Post-traumatic stress disorder among ICU survivors using Post traumatic stress disorder checklist for DSM (PCL-5) |
| 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 G Swetha |
| Designation |
Academic registrar, Drnb critical care medicine |
| Affiliation |
Apollo Main hospital, Chennai |
| Address |
A3 first floor Valliammai apt bheema sena garden street
mylapore
chennai
Chennai
TAMIL NADU
600004
India |
| Phone |
7598554342 |
| Fax |
|
| Email |
swethasuba2711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR N RAMAKRISHNAN |
| Designation |
Head & Senior Consultant, Department of Critical Care and Sleep Medicine Apollo Hospitals,Chennai. |
| Affiliation |
Apollo Main hospital, Chennai |
| Address |
A3 first floor Valliammai apt bheema sena garden street
mylapore
Chennai
TAMIL NADU
600004
India |
| Phone |
984085515 |
| Fax |
|
| Email |
icudoctor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR N RAMAKRISHNAN |
| Designation |
Head & Senior Consultant, Department of Critical Care and Sleep Medicine Apollo Hospitals,Chennai. |
| Affiliation |
Apollo Main hospital, Chennai |
| Address |
A3 first floor Valliammai apt bheema sena garden street
mylapore
Chennai
TAMIL NADU
600004
India |
| Phone |
984085515 |
| Fax |
|
| Email |
icudoctor@gmail.com |
|
|
Source of Monetary or Material Support
|
| APOLLO HOSPITALS, GREAMS ROAD, 21 GREAMS LANE, CHENNAI 600006 |
|
|
Primary Sponsor
|
| Name |
Apollo hospitals |
| Address |
Apollo hospitals,GREAMS ROAD,21 GREAMS lane,Chennai 600006 |
| 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 swetha |
Apollo main hospital chennai |
MULTIDISCIPLINARY CRITICAL CARE UNIT, wards in main block and sindoori block, Apollo hospital,GREAMS road, 21 GREAMS lane, Thousand lights, chennai 600006
Chennai
TAMIL NADU |
07598554342
swethasuba2711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethucs committee, apollo hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F430||Acute stress reaction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients more than 18 years
Patients admitted for more than 48 hours in intensive care unit and discharged from CCU(to ward, hdu, home)
|
|
| ExclusionCriteria |
| Details |
Patients with Past history of psychiatric illness
Patients unable to give consent
Multiple admissions to ICU within the same hospital admission
Patients not able to fully understand and complete the questionnaire |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the incidence of acute stress disorder among ICU survivors using PCL-5 questionnaire
|
PCL 5 Questionnaire Administered AT 1-8 days 4-6 weeks and 8-12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the incidence of PTSD among ICU survivors using PCL-5 questionnaire
To study the factors associated with incidence of acute stress disorder & PTSD among ICU survivors
|
PCL5 questionnaire administered at 1-8 days, 4-6 weeks & 8-12 weeks |
|
|
Target Sample Size
|
Total Sample Size="175"
Sample Size from India="175"
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)
|
30/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
patient admitted in ICU will be followed up at 1-8 days, 4-6 weeks and 8-12 weeks. age,gender,APACHE 4 score charlson comorbidity index, vasopressor use, benzodiazepine use, opioid use,mechanical ventiation, ICU length of stay - DATA collected. PTSD score assesed using PCL5 questionnaire. if score more than 33 - patient sent for psychiatric counselling |