| CTRI Number |
CTRI/2026/03/106886 [Registered on: 25/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Early clinical signs to predict the return of brain function and survival in patients after the heart suddenly stops beating. |
|
Scientific Title of Study
|
Early bedside clinical predictors for neurological outcome and survival
of post-cardiac arrest patients- 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 |
Vignesh Prabhu |
| Designation |
MSc Respiratory Therapy (Student) |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7259990913 |
| Fax |
|
| Email |
vignesh.mchpmpl2025@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pratibha Todur |
| Designation |
Associate Professor and Head |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
4th floor, Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8095103671 |
| Fax |
|
| Email |
pratibha.todur@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vignesh Prabhu |
| Designation |
MSc Respiratory Therapy (Student) |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7259990913 |
| Fax |
|
| Email |
vignesh.mchpmpl2025@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| 4th floor, Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal, Udupi, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
VIGNESH PRABHU |
| Address |
4th floor, Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal, Udupi, Karnataka, India, 576104 |
| Type of Sponsor |
Other [self sponsor] |
|
|
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 |
| Dr Souvik Chaudhuri |
Kasturba Hospital, Manipal, Udupi, Karnataka, India. |
Room number 01, Department of Critical Care 1st Floor, Trauma and Emergency Block, Manipal, Udupi District, Karnataka – 576104 India and room number 02, Department of Emergency Medicine, Ground Floor, Trauma and Emergency Block, Manipal, Udupi District, Karnataka – 576104, India.
Udupi
KARNATAKA |
9937178620
souvik.chaudhuri@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee-2 (student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I469||Cardiac arrest, cause unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
Those with post-cardiac arrest achieving sustained ROSC |
|
| ExclusionCriteria |
| Details |
DNR patients or the patient family decide to withhold or withdraw life sustaining care made prior to enrollment, Endstage or terminal disease patients receiving palliative care, Patients or the patient family who refuse to be a part of this study or who refuse to give consent for participation in this study, Patients who rearrest before 30 minutes of ROSC. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neurological outcome |
at 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In-Hospital Mortality |
at 4 weeks. |
| Length of ICU Stay |
at 4 weeks. |
| Ventilator-Free Days |
at 4 weeks. |
| Withdrawal of Life-Sustaining Therapy (WLST) |
at 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
04/04/2026 |
| 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="10"
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
|
This prospective observational study aims to identify early bedside clinical predictors of neurological outcome and survival in adult post-cardiac arrest patients who achieve sustained return of spontaneous circulation. The study will be conducted in the emergency department and intensive care units of a tertiary care hospital and will include patients aged more than 18 years with both in-hospital and out-of-hospital cardiac arrest. The primary objective is to assess early bedside clinical parameters associated with mortality and discharge neurological outcomes. The secondary objectives are to develop a simplified multimodal bedside prognostic score and to compare the predictive ability of these parameters between in-hospital and out-of-hospital cardiac arrest patients. Early, readily available bedside parameters, including neurological, respiratory, hemodynamic, and metabolic variables, will be recorded at predefined time points: 1st hour, 2nd hour, 6th hour, 12th hour, and 24 hours after return of spontaneous circulation. These variables include Glasgow Coma Scale, pupillary reflexes, end-tidal carbon dioxide, ventilatory parameters, vital signs, and arterial blood gas values, as available in routine care. The outcomes will be neurological status at discharge assessed using cerebral performance category score, and in-hospital mortality, length of intensive care unit stay, ventilator-free days, and withdrawal of life-sustaining therapy. Based on these predictors, a simplified multimodal bedside prognostic score will be developed. The study also aims to compare the predictive ability of these parameters between in-hospital and out-of-hospital cardiac arrest patients. This study is observational and does not involve any additional interventions beyond standard clinical care. Patients who re-arrest within 30 minutes of initial return of spontaneous circulation will be excluded from the study, as they will not meet the definition of sustained return of spontaneous circulation. Patients who are re-arrested after 30 minutes and achieve return of spontaneous circulation again will continue to be followed, and data collection will proceed as per protocol, whereas those who do not achieve return of spontaneous circulation will be included in mortality outcomes with data recorded until the time of re-arrest. The findings are expected to help in early risk stratification and development of a simple, cost-effective bedside prognostic model for use in resource-limited settings. |