| CTRI Number |
CTRI/2017/11/010350 [Registered on: 02/11/2017] Trial Registered Prospectively |
| Last Modified On: |
01/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Finding association between eye ultrasound parameter at admission to hospital in brain injury patients with clinical recovery |
|
Scientific Title of Study
|
Correlation of ultrasonographically measured optic nerve sheath diameter at admission with neurological outcome in patients with moderate to severe traumatic brain injury |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gourav Mittal |
| Designation |
Junior resident |
| Affiliation |
Postgraduate institute of medical education and research Chandigarh , |
| Address |
Department of Anaesthesia and intensive care ,4th floor, Nehru hospital , Postgraduate institute of medical education and research,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9466203593 |
| Fax |
|
| Email |
dr.gmittal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Panda |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education and research,Chandigarh |
| Address |
Department of Anaesthesia and intensive care ,4th floor, Postgraduate institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009525 |
| Fax |
|
| Email |
nidhibp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Panda |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education and research ,Chandigarh |
| Address |
Department of Anaesthesia and intensive care ,4th floor, Postgraduate institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009525 |
| Fax |
|
| Email |
nidhibp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and intensive care,4th floor Post graduate institute of medical education and research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia and intensive care |
| Address |
Postgraduate institute of medical education and research Chandigarh |
| 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 |
| Gourav mittal |
Postgraduate institute of medical education and research, chandigarh |
Advanced trauma center, Postgraduate institute of medical education and research Chandigarh
Chandigarh
CHANDIGARH |
9466203593
dr.gmittal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, post graduate institute of medical education and research , chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Adult patient having moderate to severe isolated Traumatic brain injury, (1) ICD-10 Condition: S060||Concussion, (2) ICD-10 Condition: S061||Traumatic cerebral edema, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Traumatic brain injury (TBI)
2.Age - 18-60 years
3.Isolated TBI
4.Patients admitting to Advanced Trauma Center, Postgraduate institute of medical education and research, Chandigarh within 24 hours of Head Injury
|
|
| ExclusionCriteria |
| Details |
1.Age <18 year or > 60 years
2.TBI with major orthopedic trauma
3.Orbital trauma and orbital nerve lesions
4.If neurosurgical intervention done prior to Advanced Trauma Center admission
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of ONSD measured by ultrasonography in moderate-severe isolated head injury patients at admission with neurological outcome assessed by GOS-E at 1 months and 3 months |
1 month and 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of Pulsatility index (PI) measured by TCD in moderate-severe isolated head injury patients at admission with neurological outcome assessed by GOS-E at 1 months and 3 months |
1 month and 3 month |
| Correlation of Marshall Score from CT Scan in moderate-severe isolated head injury patients at admission with neurological outcome assessed by GOS-E at 1 months and GOS-E at 3 months |
1 month and 3 month |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
10/11/2017 |
| 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="11"
Days="20" |
|
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)?
|
|
Brief Summary
|
Neuro-monitoring using noninvasive techniques can have therapeutic and prognostic implications especially in isolated moderate to severe Traumatic Brain Injury (TBI) patients. To the best of our knowledge, no study till date has correlated ultrasonographically(USG) measured Optic Nerve Sheath Diameter (ONSD) with outcome in patients with isolated moderate to severe TBI. Hence, we hypothesize that Intracranial Pressure measured by noninvasive methods such as measurement of ONSD by USG and Pulsatality Index (PI) by Transcranail doppler ( TCD) at hospital admission (within 24 hours of injury) may correlate with early neurological outcome in patients with isolated moderate to severe TBI. We plan an observational study to find correlation of ultrasound measured ONSD at admission with early neurological outcome (at post-injury one month and three months) in patients with moderate to severe traumatic brain injury. |