| CTRI Number |
CTRI/2025/05/087000 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the usefulness of ONSD and NSE in predicting neurological outcomes after In Hospital cardiac arrest. |
|
Scientific Title of Study
|
To assess the usefulness of optic nerve sheath diameter and Neuron Specific Enolase in predicting neurological outcomes after In Hospital cardiac arrest. |
| 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 Aman Rathore |
| Designation |
SENIOR RESIDENT |
| Affiliation |
max superspeciality hospital, vaishali |
| Address |
Medical ICU, 6 Floor,
Max superspeciality hospital w-3 sector 1, vaishali, Ghaziabad- 201012 UP
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9205027307 |
| Fax |
|
| Email |
amanrathore235@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Gupta |
| Designation |
Head of Department |
| Affiliation |
max superspeciality hospital, vaishali |
| Address |
Medical ICU, 6 Floor,
Max superspeciality hospital w-3 sector 1, vaishali, Ghaziabad- 201012 UP
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9868081770 |
| Fax |
|
| Email |
Manish.gupta@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aman Rathore |
| Designation |
SENIOR RESIDENT |
| Affiliation |
max superspeciality hospital, vaishali |
| Address |
Medical ICU, 6 Floor,
Max superspeciality hospital w-3 sector 1, vaishali, Ghaziabad- 201012 UP
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9205027307 |
| Fax |
|
| Email |
amanrathore235@outlook.com |
|
|
Source of Monetary or Material Support
|
| Max superspeciality Hospital, w-3, sector 1 Vaishali, Ghaziabad- 201012, UP India |
|
|
Primary Sponsor
|
| Name |
MAX SUPERSPECIALITY HOSPITAL |
| Address |
Max superspeciality hospital, w-3 sector 1 Vaishali, Ghaziabad, UP India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| AMAN RATHORE |
Max superspeciality Hospital, Vaishali |
Medical ICU 6th Floor
Ghaziabad
UTTAR PRADESH |
9205027307
amanrathore235@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
In hospital cardiac arrest patient
|
|
| ExclusionCriteria |
| Details |
Cardiac arrest in patients with RTA
interrupted TTM
intracranial hemorrhage
any opthalmic disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neurological assessment in post cardiac arrest patient. |
21 days |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
30/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/05/2025 |
| 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 Yet Recruiting |
| 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
|
Postcardiac arrest brain injury is the main cuase of long term diasbility in those who survive the acute phase. even among those who survive the acute phase. in this prospective observational study will be conducted in max hospital vaishali . patient will be recruited as per inclusion criteriaas mentioned. ONSD measurment will be taken on day 1 2 and 3 post cradiac arrest survival and NSE will be taken on day 3 post cardiac arrest survival through cpc scoring. the sensitivity and specificty of this test will be carried out. |