| CTRI Number |
CTRI/2025/02/080285 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE |
| Study Design |
Other |
|
Public Title of Study
|
Neurocognitive and Psychological outcome of patients admitted in ICU |
|
Scientific Title of Study
|
Neurocognitive and Psychological Outcomes and Their Correlates in Critically Ill Patients of A Tertiary Care Hospital in Kolkata |
| 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 |
ASSISTANT PROFESSOR |
| Affiliation |
RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES |
| Address |
50A KENDUA MAIN ROAD
P.O.- GARIA,P.S.- PATULI
KOLKATA
DIST - SOUTH 24 PGS
124, MUKUNDAPUR, E.M. BYPASS
KOLKATA - 700099 South Twentyfour Parganas WEST BENGAL 700084 India |
| Phone |
9051908111 |
| Fax |
|
| Email |
ipsitaonline2020@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
IPSITA BAGCHI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES |
| Address |
50A KENDUA MAIN ROAD
P.O.- GARIA,P.S.- PATULI
KOLKATA
DIST - SOUTH 24 PGS
124, MUKUNDAPUR, E.M. BYPASS
KOLKATA - 700099 South Twentyfour Parganas WEST BENGAL 700084 India |
| Phone |
9051908111 |
| Fax |
|
| Email |
ipsitaonline2020@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
IPSITA BAGCHI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES |
| Address |
50A KENDUA MAIN ROAD
P.O.- GARIA,P.S.- PATULI
KOLKATA
DIST - SOUTH 24 PGS
124, MUKUNDAPUR, E.M. BYPASS
KOLKATA - 700099 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 |
| PROF DR KASTURI MANDAL |
RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES |
124, MUKUNDAPUR, E.M. BYPASS
KOLKATA - 700099 South Twentyfour Parganas WEST BENGAL |
7980757597
mandalkasturi.study@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
|
|
|
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. Identification of neurocognitive outcome among the critically ill patients.
2. Identification of psychological outcome among the critically ill patients.
3. Correlates of neurocognitive outcome among the critically ill patients.
4. Correlates of psychological outcome among the critically ill patients.
|
Till the fulfillment of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relationship between neurocognitive & psychological outcome among critically ill patients.
|
Till the fulfillment of the study |
|
|
Target Sample Size
|
Total Sample Size="245" Sample Size from India="245"
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)
|
15/02/2025 |
| 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="3" Months="0" 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
|
SummaryThe proposed study titled “Neurocognitive and Psychological Outcomes and Their Correlates in Critically Ill Patients of a Tertiary Care Hospital in Kolkata” will be a descriptive correlational study. The main aim of the study will be to assess the Neurocognitive and Psychological outcomes in critically ill adult patients admitted in Critical Care Unit. The primary objectives of the study will be to identify the neurocognitive outcome and psychological outcome among the critically ill patients & to find out the correlates of neurocognitive outcome and psychological outcome among the critically ill patients. Sampling will be done by consecutive sampling technique with sample size being two hundred and forty-five. The critically ill adult patients aged between eighteen to sixty years admitted in ICU during the period of data collection with willingness to participate in the study will be the inclusion criteria. Any patients with history of previous psychological disorders, impaired conscious level, mental retardation, and/or with difficulty in speaking or communication will be excluded from the study. The withdrawal criteria will be the patients with unfortunate demise during the period of data collection or any patients taking DORB/DAMA/LAMA. After obtaining formal administrative permission from facility director of NH Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata and ethical clearance from the ethics committee of the same institute, a written informed consent ensuring the willingness for participation in the study will be obtained from the patients/relatives. Initially, a pilot study comprising of ten percent of the sample size will be conducted, after completion of which, the data collection for the proposed study will be commenced. Data from the selected patients will be collected, after establishing rapport and proper self introduction. Patients’ memory regarding stressful events will be assessed by using The Stressful Memory Assessment Checklist for the ICU “SMAC-ICU”. Neurocognitive data will be collected by using Confusion Assessment Method for the Intensive Care Unit “CAM-ICU” (delirium) and Addenbrooke’s Cognitive Examination - ACE-III (cognitive status) while psychological data will be collected by using Hospital anxiety and Depression Scale “HADS” (anxiety & depression). Clinical profile will be assessed by using record analysis proforma which will include working diagnosis, cause of Critical Care Unit stays, type of ventilatory support, duration of mechanical ventilation, weaning failure, events of re-intubation, the reason for the need of mechanical ventilation and APACHE III score. Data regarding the correlates will consist of age, gender, co-morbidities, memory of stressful events, total length of ICU stay, total length of hospital stay, duration of sedation used, oxygen administration status, arterial blood gas values, vital parameters, blood parameters, medication history, presence and nature of indwelling catheters and its duration. Data analysis will be done by appropriate statistical tests. |