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CTRI Number  CTRI/2022/07/044038 [Registered on: 15/07/2022] Trial Registered Prospectively
Last Modified On: 14/07/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Questionnaire based survey 
Study Design  Other 
Public Title of Study   Post Intensive Care Survey(PICS) 
Scientific Title of Study   Questionnaire based observational study on epidemiology of Post Intensive Care Syndrome (PICS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amrita Bhattacharyya 
Designation  Head , Respiratory Intensive Care Unit 
Affiliation  The Calcutta Medical Research Institute 
Address  Respiratory Intensive Care Unit(RICU) Level 4 The Calcutta Medical Research Institute 7/2 Diamond Harbour Road Kolkata-700027

Kolkata
WEST BENGAL
Kolkata 700027
India 
Phone    
Fax    
Email  pupuldoc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amrita Bhattacharyya 
Designation  Head , Respiratory Intensive Care Unit 
Affiliation  The Calcutta Medical Research Institute 
Address  Respiratory Intensive Care Unit(RICU) Level 4 The Calcutta Medical Research Institute 7/2 Diamond Harbour Road Kolkata-700027


WEST BENGAL
Kolkata 700027
India 
Phone    
Fax    
Email  pupuldoc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amrita Bhattacharyya 
Designation  Head , Respiratory Intensive Care Unit 
Affiliation  The Calcutta Medical Research Institute 
Address  Respiratory Intensive Care Unit(RICU) Level 4 The Calcutta Medical Research Institute 7/2 Diamond Harbour Road Kolkata-700027


WEST BENGAL
Kolkata 700027
India 
Phone    
Fax    
Email  pupuldoc@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  The Calcutta Medical Research Institute 
Address  The Calcutta Medical Research Institute 7/2 Diamond Harbour Road Kolkata-700027 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amrita Bhattacharyya  The Calcutta Medical Research Institute  Respiratory Intensive care unit(RICU) Level 4 The Calcutta Medical Research Institute 7/2 Diamond Harbour Road Kolkata-700027
Kolkata
WEST BENGAL 		 9919645454

pupuldoc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics CommitteeTheCalcutta Medical Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. hypercapnia ( pco2> 45 on admission ) or hypoxia ( p/f < 200) on admission
2. Requiring advanced respiratory support during icu admission ( respiratory support defined as NIV , or HFNO or invasive mechanical ventilation )
3. Vasopressor requirement
4. HD for AKI
5. Delirium for > 48 hours
 
 
ExclusionCriteria 
Details  1. Age < 18
2. Pregnancy
3. MMSE < 17
4. Patients offered palliative care
5. patients who had primary brain injury that was likely to result in conscious or cognitive disorder (e.g., traumatic brain injury, subarachnoid hemorrhage, acute stroke, post cardiac arrest, meningitis, and encephalitis);
6. patients with pre-admission diagnosis of dementia;
7. patients who received home ventilation prior to admission;
8. patients with end-stage cancer;
9. patients with withdraw/withhold status;
10. expected death within 24 h;
11. second or subsequent admission to ICU during the study period;
12. ICU stay < 48 hours


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
the epidemiology of PICS and its sub syndromes in ICU patient   15 days , 2 months and 6 months post discharge 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/07/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The purpose of the study is  to detect the epidemiology of PICS and its sub syndromes in ICU patients at 15 days , 2 months and 6 months post discharge.

Post-intensive care syndrome (PICS) is a group of problems that people can experience after surviving a life-threatening illness. More than half (50 percent) of all people who survive a hospital stay in the intensive care unit (ICU) will have at least one of the problems seen with PICS. These problems can greatly affect the lives of survivors of critical illness. There are mainly three kinds of problems :physical function mental health  or cognitive function

The HABC represents a comprehensive and logistically easily administrable questionnaire to study quality of life post PICS. We hope to study the demographics of PICS in our population and correlate it with the relatively more established SF 36 questionnare.

We plan to administer this questionnaire at 15 days post discharge to screen for PICS in all ICU admissions and then after 2 months and 6 months post discharge over telephone or follow up visit dates.

 
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