| CTRI Number |
CTRI/2024/12/078820 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prediction of Intracranial pressure by ocular ultrasound
in patients posted for intracranial neurosurgery
|
|
Scientific Title of Study
|
Prediction of Intracranial pressure by ocular ultrasound
in patients posted for intracranial neurosurgery
- A clinical correlation |
| 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 SRIDEVI MULIMANI |
| Designation |
Professor |
| Affiliation |
BLDE DU Shri B M Patil Medical College Hospital and Research Center |
| Address |
Department of Anaesthesiology, 3rd floor, BLDE DU Shri B M Patil Medical College Hospital and Research Center, Bangaramma Sajjan Campus, Solapur Road, Vijayapura
BLDE DU Shri B M Patil Medical College Hospital and Research Center, Bangaramma Sajjan Campus, Solapur Road, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9449534216 |
| Fax |
|
| Email |
sridevi.mulimani@bldedu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Shreedher Priyan |
| Designation |
PG Student |
| Affiliation |
BLDE DU Shri B M Patil Medical College Hospital and Research Center |
| Address |
Department of Anaesthesiology, 3rd floor, BLDE DU Shri B M Patil Medical College Hospital and Research Center, Bangaramma Sajjan Campus, Solapur Road, Vijayapura
BLDE DU Shri B M Patil Medical College Hospital and Reserch Center, Bangaramma Sajjan Campus, Solapur Road, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
7418323557 |
| Fax |
|
| Email |
shreedherpriyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SRIDEVI MULIMANI |
| Designation |
Professor |
| Affiliation |
BLDE DU Shri B M Patil Medical College Hospital and Research Center |
| Address |
Department of Anaesthesiology, 3rd floor, BLDE DU Shri B M Patil Medical College Hospital Research Center, Bangaramma Sajjan Campus, Solapur Road, Vijayapura
Department of Anaesthesiology, 3rd floor, BLDE DU Shri B M Patil Medical College Hospital Research Center, Bangaramma Sajjan Campus, Solapur Road, Vijayapura
KARNATAKA
586103
India |
| Phone |
9449534216 |
| Fax |
|
| Email |
sridevi.mulimani@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| BLDE DU Shri B M Patil Medical College Hospital Research Center, Bangaramma Sajjan Campus, Solapur Road, Vijayapura |
|
|
Primary Sponsor
|
| Name |
BLDE DU Shri B M Patil Medical College Hospital and Research Center |
| Address |
Solapur Road, Bangaramma Sajjan Campus, Vijayapura, Karnataka - 586103 |
| 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 Shreedher Priyan Nandhakumar |
Shri B M Patil Medical College Hospital and Research Center |
Department of Anaesthesiology, 3rd floor, BLDE DU Shri B M Patil Medical College Hospital and Research Center, Solapur Road, Bangaramma Sajjan Campus, Vijayapura
Bijapur
KARNATAKA |
7418323557
shreedherpriyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethical Committee of Shri B M Patil Medical College Hospital and Research Center of BLDE Deemed to be University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G932||Benign intracranial hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil as it is an observational study |
nil as it is an observational study |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 20-60 years.
2. Patients admitted for intracranial neuro surgeries of space occupying lesions
(Conditions where ICP-monitoring is used which are Intracerebral haemorrhage,
Subarachnoid haemorrhage, Traumatic head injury and Intracranial tumors)
3. Patients with anti-edema prescription
4. Patients with GCS score more than 8
5. Elective as well as emergency intracranial neuro surgical cases
6. Traumatic as well as non-traumatic intracranial neurosurgical cases
7. Patients with comorbidities Diabetes and hypertension |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Co-existing ophthalmic and neurological diseases
3. Patients with orbit or eyelid injuries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To predict the Intracranial pressure of the patients posted for intracranial
neuro surgery in pre operative room
1. By measuring optic nerve sheath diameter (ONSD) (millimeter)
2. By measuring the eyeball transverse diameter (ETD) (millimeter)
3. Calculating ONSD: ETD ratio |
Assessed immediately at the time of performing the scan |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlating the diagnostic accuracy of ONSD & ONSD :
1. ETD ratio with
clinical & radiological parameters of patients posted for intracranial neuro surgery in pre
operative room
2. the ONSD varies from 3.65 mm to 5.17 mm (7)
3. The normal ETD varies from 21 mm to 27 mm. (8)
4. The ONSD/ETD ratio range from 0.1 to 0.23, with a mean ratio of 0.17 |
Assessed immediately at the time of performing the scan |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
10/01/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shreedherpriyan@gmail.com].
- For how long will this data be available start date provided 01-10-2024 and end date provided 01-10-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Increased intracranial pressure (ICP) is a common problem in intracranial neurosurgical patients presenting with mass-occupying lesion and traumatic brain injury, treatment in both elective and emergency cases is directly related to the postoperative outcome. It is most important to predict the status of ICP in the immediate preoperative period for the management of intracranial pressure in intraoperative and postoperative period.The aim of the study is to predict Intracranial pressure by ocular Ultrasound and correlating them with clinical and radiological parameters of patients posted for intracranial neurosurgery patients.Patient fitting the inclusion and exclusion criteria will undergo an ultrasonographic examination; maximum external diameter of Optic Nerve Sheath Diameter and Eyeball transverse diameter will be calculated. The data will be analysed using SPSS Version 20.
|