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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  
SELF SPONSORED 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
 
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  

Summary

The 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.

 
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