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CTRI Number  CTRI/2025/09/094478 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   FOUR score vs GCS-P Score for predicting outcome in the patients after cardiac arrest 
Scientific Title of Study   “Comparison between Full Outline of UnResponsiveness (FOUR) score and Glasgow Coma Scale-Pupils (GCS-P) Score for predicting outcome in the patients after cardiac arrest- a prospective observational study” 
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 Akshay Yadav 
Designation  DrNB Trainee, Department of Critical Care Medicine, Jaslok Hospital and Research Centre, Mumbai 
Affiliation  aslok Hospital and Research Centre, 15, Dr G D Marg, Mumbai, Maharashtra 
Address  5th Floor, Department of Critical Care Medicine, Jaslok Hospital and Research Centre, 15, Dr G D Marg, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400026
India 
Phone  9673334149  
Fax    
Email  yadav.aksh6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Indraneel Raut 
Designation  Additional director, Department of Critical Care Medicine, Jaslok Hospital and Research Centre, Mumbai 
Affiliation  Department of Critical Care Medicine, Jaslok Hospital and Research Centre, 15, Dr G D Marg, Mumbai, Maharashtra 
Address  5th Floor, Department of Critical Care Medicine, Jaslok Hospital and Research Centre, 15, Dr G D Marg, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400026
India 
Phone  9324274985  
Fax    
Email  indru1375@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akshay Yadav 
Designation  DrNB Trainee, Department of Critical Care Medicine, Jaslok Hospital and Research Centre, Mumbai 
Affiliation  Jaslok Hospital and Research Centre, 15, Dr G D Marg, Mumbai, Maharashtra 
Address  5th Floor, Department of Critical Care Medicine, Jaslok Hospital and Research Centre, 15, Dr G D Marg, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400026
India 
Phone  9673334149  
Fax    
Email  yadav.aksh6@gmail.com  
 
Source of Monetary or Material Support  
Jaslok Hospital and Research Centre, 15, Dr G D Marg, Mumbai, Maharashtra- 400026 
 
Primary Sponsor  
Name  Jaslok Hospital and Research Centre 
Address  15, Dr G D Marg, Mumbai, Maharashtra- 400026 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Akshay Sudhir Yadav  Jaslok Hospital and Research Centre  Intensive Care Units, Department of Critical Care Medicine, Jaslok Hospital and Research Center, 15, Dr. G. D. Marg, Mumbai- 400026
Mumbai
MAHARASHTRA 		 9673334149

yadav.aksh6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Jaslok Hospital and Research Centre, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I469||Cardiac arrest, cause unspecified, (2) ICD-10 Condition: I462||Cardiac arrest due to underlying cardiac condition, (3) ICD-10 Condition: I468||Cardiac arrest due to other underlying condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients getting admitted in the ICU of Jaslok Hospital and Research Centre, after
an episode of cardiac arrest.
2. Patients who are already admitted in the ICU of Jaslok Hospital and Research
Centre; and are not on any invasive ventilatory support or ionotropic supports or
any palliative care; and then have an episode of sudden cardiac arrest  
 
ExclusionCriteria 
Details  1. Refusal by the legally accepted representative to enroll the patient for this study.
2. Patients who are on invasive ventilatory support, already admitted in the ICU of Jaslok Hospital and Research Centre; and then have an episode of sudden cardiac arrest
3. Patients who are on ionotropic supports, already admitted in the ICU of Jaslok Hospital and Research Centre; and then have an episode of sudden cardiac arrest.
4. Patients who are on palliative care, already admitted in the ICU of Jaslok Hospital and Research Centre; and then have an episode of sudden cardiac arrest.
5. Patients who died within 6 hours of ICU admission, after an episode of cardiac arrest
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess FOUR score and GCS-P score in terms of their ability to predict in-hospital mortality in patients after cardiac arrest  In-hospital mortality whenever it happens 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate FOUR score & GCS-P score in terms of their ability to predict functional neurological outcome in patients who survive after an episode of cardiac arrest.  Modified Rankin Scale score at discharge & at 3 months 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   25/09/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   After procuring approval from the institutional ethics committee, we will prospectively enroll the patients who are satisfying the inclusion criteria. While the patients satisfying the exclusion criteria will be excluded. The study will be carried out for a period of 18 months.  The representative of the subject will be explained about the study and a written valid informed consent for their willingness will be taken before enrolling the patient for the study. The patients will be shifted to the ICU, after resuscitating them as per the recent ACLS (Advanced Cardiovascular Life Support) guidelines. After stabilizing the patient in the ICU; the patient’s demographic details, details of comorbidities (if any), previous history of cardiac arrest and resuscitation, and details of previous surgeries (if any) will be noted. Following this, a thorough neurological assessment will be done to record the FOUR score and GCS-P score. The length of stay of the patient in ICU after cardiac arrest will also be noted. Similar neurological assessments will be done at 24 hours, 48 hours, 72 hours, and 120 hours after the cardiac arrest to note down GCS-P and FOUR scores. In-hospital mortality for the enrolled patients will be noted. The functional neurological outcome will be assessed at discharge and 3 months after the cardiac arrest, using the Modified Rankin Scale (mRS). After 3 months, this assessment will be done physically, if the patients are still staying in Mumbai. In case the patient is not staying in Mumbai; we will telephonically communicate with the family physician who is taking care of the patient and will accordingly note down the findings of the assessment. In case the family physician is not involved in the patient care, we will assess the patient using a video call. 
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