| CTRI Number |
CTRI/2024/12/077523 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
usefulness of eye ultrasound for brain injury patients |
|
Scientific Title of Study
|
BEDSIDE ULTRASONOGRAPHIC OPTIC NERVE SHEATH DIAMETER TO ASSESS INCREASED INTRA-CRANIAL PRESSURE: AN 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 |
SAURAV SHEKHAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
DEPARTMENT OF ANESTHESIOLOGY (TRAUMA & EMERGENCY)
IGIMS
PATNA
Patna BIHAR 800014 India |
| Phone |
9308921568 |
| Fax |
|
| Email |
sauravshekhar99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
SAURAV SHEKHAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
DEPARTMENT OF ANESTHESIOLOGY (TRAUMA & EMERGENCY)
IGIMS
PATNA
BIHAR 800014 India |
| Phone |
9308921568 |
| Fax |
|
| Email |
sauravshekhar99@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
SAURAV SHEKHAR |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
DEPARTMENT OF ANESTHESIOLOGY (TRAUMA & EMERGENCY)
IGIMS
PATNA
BIHAR 800014 India |
| Phone |
9308921568 |
| Fax |
|
| Email |
sauravshekhar99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anesthesiology
Trauma & Emergency
Indira Gandhi Institute of Medical Sciences
Patna
Bihar 800001
Patna |
|
|
Primary Sponsor
|
| Name |
DR SAURAV SHEKHAR |
| Address |
Department of Anesthesiology (Trauma & Emergency)
IGIMS
Patna 800014
Bihar
PATNA |
| Type of Sponsor |
Other [self] |
|
|
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 Saurav Shekhar |
Indira Gandhi Institute of Medical Sciences |
DEPARTMENT OF ANESTHESIOLOGY (TRAUMA & EMERGENCY)
IGIMS
PATNA Patna BIHAR |
09308921568
sauravshekhar99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S062||Diffuse traumatic brain injury, (2) ICD-10 Condition: S064||Epidural hemorrhage, (3) ICD-10 Condition: S068||Other specified intracranial injuries, (4) ICD-10 Condition: S061||Traumatic cerebral edema, (5) ICD-10 Condition: S065||Traumatic subdural hemorrhage, (6) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
all patients with traumatic brain injury having raised intracranial pressure such as ICH, STROKE and diffuse axonal injuries. |
|
| ExclusionCriteria |
| Details |
patients with previous specific traumatic or structural ophthalmological pathology.
Age <18 years or >60 years,
eye or orbit diseases such as glaucoma, lens opacity or trauma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) To correlate increase in optic nerve sheath diameter to raised intra-cranial pressure. |
baseline
24hrs
48hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to validate findings with gcs score |
0, 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
15/12/2024 |
| 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="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Point of care optic nerve sheath ultrasound (ONSUS) is a bedside practice that can be used to evaluate for increased intracranial pressure. Systematic review and meta-analysis have shown that ONSD of more than 5.00 to 5.70 mm has a concurrent ICP value above 20 mm Hg. The use of point-of-care ultrasound (POCUS) has expanded considerably over the past two decades allowing for enhanced and swift evaluations, rapid triage, improved diagnostic capabilities in austere situations, and real-time assessment of focused clinical questions in critically ill patients in the intensive care unit (ICU). Emergency medicine physicians have led the way in establishing and educating bedside use of ultrasound. In 2001, the American College of Emergency Physicians (ACEP) published the first Emergency Ultrasound Guidelines to clarify the primary indications, the scope of practice, training, and continuing education regarding the use of emergency ultrasound. The main complication associated with cerebral acute brain injury (ABI) is elevated intracranial pressure (ICP), as it is associated with high morbidity and mortality. Intracranial hypertension is defined as a sustained ICP greater than 20 mm Hg. In these patients, multimodal neurological monitoring has positioned itself as a fundamental tool, both in emergency departments and in intensive care units (ICU), with a tendency, in recent years, to be minimally invasive. So much so that, in the care of these patients, the detection of increased ICP remains crucial, since it is associated with a worse prognosis. Thus, its early and timely diagnosis together with the implementation of adequate therapeutic measures are essential to ensure better patient outcomes. Ultrasound evaluation of the optic nerve sheath diameter (ONSD) has emerged in recent years as a useful non-invasive tool for estimating ICP or detecting intracranial hypertension. It is a safe technique that can be conducted at the bedside, in real time, and is reproducible, relatively low cost, and does not carry the risks of radiation. OBJECTIVES: 1) To correlate increase in optic nerve sheath diameter to raised intra-cranial pressure. 2) To assess ONSD as predictor of unfavaourable outcome |