| CTRI Number |
CTRI/2025/07/090503 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Developing a model with predisposing factors for predicting a positive finding in brain imaging of critically ill patients admitted to the intenisve acre unit with altered consciousness not due to trauma. |
|
Scientific Title of Study
|
Development and validation of a prediction model for improving the diagnostic yield of brain imaging modalities in critically ill patients with nontraumatic encephalopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meenupriya Arasu |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology and Critical care, Academic section,
5th floor, AIIMS, Ansari nagar, New Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
7708024354 |
| Fax |
|
| Email |
meenupriya1193@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vimi Rewari |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology and Critical care, Academic section,
5th floor, AIIMS, Ansari nagar, New Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
9818304880 |
| Fax |
|
| Email |
vimirewari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meenupriya Arasu |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology and Critical care, Academic section,
5th floor, AIIMS, Ansari nagar, New Delhi, India
DELHI
110029
India |
| Phone |
7708024354 |
| Fax |
|
| Email |
meenupriya1193@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Scineces, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Research and Intramural Grant, AIIMS, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Meenupriya Arasu |
All India Institute of Medical Sciences (AIIMS) |
Department of
Anaesthesiology and
Critical care, Academic
section, 5th floor,
AIIMS, Ansari nagar,
New Delhi, India
New Delhi
DELHI |
7708024354
meenupriya1193@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients admitted to the ICU who underwent CT or MRI head for evaluation of nontraumatic encephalopathy during their ICU stay in All India Institute of Medical sciences New Delhi from January 2020 to December 2024 will be screened for eligibility in the study.
Nontraumatic encephalopathy is defined as any new onset disturbance or worsening of baseline cognition or behavior and neurological function.
2.If multiple imaging is being done for the same patient then the outcome of each scan will be counted separately.
|
|
| ExclusionCriteria |
| Details |
1.Patients who did not undergo any CT/MRI of head during their ICU stay.
2.Patients with traumatic brain injury undergoing CT/ MRI head.
3.CT/ MRI scan in post-neurosurgical patients.
4.CT/ MRI scan done before the ICU admission.
5.CT/MRI done as a follow-up of already established chronic neurological diseases.
6.CT/MRI scans performed for interventional imagery, such as a CT scan-guided procedures that the patient underwent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To elucidate the clinical predictors associated with a positive diagnosis on CT/MRI of the brain and to develop a nomogram prediction model for predicting a positive diagnostic scan.
|
After approval by CTRI, the data will be collected from ICU charts will be reviewed by retrospective chart review at the following timepoints:
1.On the day of ICU admission for baseline data
2. On the day of CT/MRI brain imaging and next day for the diagnostic yield and any treatment change event
3.Till the last day of ICU stay for estimation of duration of ICU stay and mortality.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the discriminating power of the developed prediction model.
Internal validation of the prediction model by splitting the entire dataset into development cohort & validation cohort at a 70:30 ratio.
To evaluate the diagnostic yield of the development cohort vs the validation cohort.
To evaluate the therapeutic yield of the development cohort vs the validation cohort. |
The datasetfrom retrospective chart review will collected at the following timepoints:
1.On the day of ICU admission for baseline data
2. On the day of CT/MRI brain imaging & next day for the diagnostic yield & any treatment change event
3.Till the last day of ICU stay for estimation of duration of ICU stay & mortality. |
|
|
Target Sample Size
|
Total Sample Size="556"
Sample Size from India="556"
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)
|
25/07/2025 |
| 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="2"
Months="0"
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 CTRI approval, the patients admitted to the ICU of All India Institute of Medical sciences, New Delhi from January 2020 to December 2024, who underwent CT /MRI head for evaluation of nontraumatic encephalopathy during their ICU stay will be screened for eligibility to meet the required sample size of 556. The demographical, clinical, radiological and laboratory data will be collected through a retrospective review of the ICU charts, laboratory and radiological reports from the electronic and inpatient medical records databases of our hospital. The indication for the CT/MRI requisition will be noted from the physician orders in the ICU charts. The neurological findings including any new focal neurological deficit (FND) and signs of raised intracranial pressure (ICP) will be noted from the physician’s notes. The radiological study outcomes and the treatment changes will be noted.
|