| CTRI Number |
CTRI/2025/08/092450 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Trustworthiness and Effectiveness of Bengali Version of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for Detection of Delirium |
|
Scientific Title of Study
|
Reliability and Validity of the Bengali Version of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for Diagnosis of Delirium |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
IPSITA BAGCHI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES |
| Address |
50A KENDUA MAIN ROAD P.O.- GARIA,P.S-PATULI KOLKATA DIST
KOLKATA
INDIA
South Twentyfour Parganas
WEST BENGAL
700084
India |
| Phone |
9051908111 |
| Fax |
|
| Email |
ipsitaonline2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
IPSITA BAGCHI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES |
| Address |
50A KENDUA MAIN ROAD P.O.- GARIA,P.S.-PATULI KOLKATA DIST
KOLKATA
INDIA
South Twentyfour Parganas
WEST BENGAL
700084
India |
| Phone |
9051908111 |
| Fax |
|
| Email |
ipsitaonline2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
IPSITA BAGCHI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES |
| Address |
50A KENDUA MAIN ROAD P.O.- GARIA,P.S.-PATULI KOLKATA DIST
KOLKATA
INDIA
South Twentyfour Parganas
WEST BENGAL
700084
India |
| Phone |
9051908111 |
| Fax |
|
| Email |
ipsitaonline2020@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPSITA BAGCHI |
| Address |
50A KENDUA MAIN ROAD P.O. - GARIA, P.S. - PATULI, KOLKATA -700084 |
| Type of Sponsor |
Other [SELF-SPONSORED] |
|
|
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 |
| IPSITA BAGCHI |
NH RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES |
124, MUKUNDAPUR, E.M. BYPASS KOLKATA-700099
South Twentyfour Parganas
WEST BENGAL |
9051908111
ipsitaonline2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NHRTIICS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Critically ill patients, well versed in bengali and/or english, admitted in ICU during the period of data collection and willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Patients with previous history of psychological disorders.
2. Patient associated with impaired conscious level.
3. Patient with mental retardation.
4. Patient with difficulty in speaking or communication |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.)To determine the reliability of Bengali version of CAM-ICU
2.)To determine the validity of Bengali version of CAM-ICU |
1 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
16/08/2025 |
| 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="0"
Months="0"
Days="10" |
|
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
|
The proposed study titled "Reliability and Validity of Bengali Version of the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for Diagnosis of Delirium" will be a Descriptive study. This study will be a sub study of the original study titled "Neurocognitive and Psychological Outcomes and Their Correlates in critically Ill Patients of a Tertiary Care Hospital in Kolkata" (CTRI/2025/02/080285). The rationale of the study is the lack of availability of the Bengali dialect of CAM-ICU for assessment of delirium in the Bengali speaking regions of India. The primary objectives of the proposed study is :1.) to determine reliability of the bengali version of CAM-ICU, 2.) to determine the validity of the Bengali version of CAM-ICU. The inclusion criteria of the proposed study is Critically ill patients, well versed in bengali and/or english, admitted in ICU during the period of data collection and willing to participate in the study. the exclusion criteria of the study are the patients with impaired consciousness level, mental retardation, difficulty in speaking or communication and/or with previous history of psychological disorders. A written informed consent ensuring the willingness for participation in the study will be obtained from the patients/relatives. original english version will be translated to bengali (forward translation) and then will be translated back to english (back translation). Then, the original version and the backward translated version of CAM-ICU will be compared by the experts. After that the bengali version of the CAM-ICU will be used to collect data. sample size will comprise of 65 patients. sampling technique will be by consecutive sampling technique . Statistical plan will comprise of interrater reliability, internal consistency and construct validity |