| CTRI Number |
CTRI/2022/08/044921 [Registered on: 25/08/2022] Trial Registered Prospectively |
| Last Modified On: |
24/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating utility of ultrasonographic eye nerve diameter in relation with invasive intracranial pressure measurement in children with hydrocephalus |
|
Scientific Title of Study
|
Ultrasonographic evaluation of the changes in optic nerve sheath diameter as a useful point of care tool to supplement invasive intracranial pressure measurement in paediatric patients with hydrocephalus undergoing neurosurgical intervention |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Malika Dhawal |
| Designation |
Junior Resident |
| Affiliation |
King George medical university |
| Address |
Department of Anaesthesiology
King George Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7905231021 |
| Fax |
|
| Email |
dmalika189@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica Kohli |
| Designation |
Professor, MD Anaesthesiology |
| Affiliation |
King George medical university |
| Address |
Department of Anaesthesiology
King George Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839041228 |
| Fax |
|
| Email |
monica_kohli@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica kohli |
| Designation |
Professor, MD Anaesthesiology |
| Affiliation |
King George medical university |
| Address |
Department of Anaesthesiology
King George Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839041228 |
| Fax |
|
| Email |
monica_kohli@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department ofAnaesthesiology,
King george medical college |
|
|
Primary Sponsor
|
| Name |
King george medical college |
| Address |
Department of Anaesthesiology,
Kgmu lucknow |
| Type of Sponsor |
Government medical college |
|
|
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 Monica Kohli |
King george medical university |
Department of Anaesthesiology
King george medical college
Lucknow
UTTAR PRADESH |
9839041228
monica_kohli@rediffmail.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: G919||Hydrocephalus, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA Grade I AND II
2 Patient undergoing neurosurgeries lasting less than 4 hours
|
|
| ExclusionCriteria |
| Details |
1 ASA Grade III and IV
2 Eye or orbit disease, such as glaucoma, lens opacity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the change in optic nerve sheath diameter after surgical intervention |
After intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the ultrasonographic optic nerve sheath diameter with invasion intracranial pressure measurement. |
Before extubation |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
30/08/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet recruiting |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ocular Sonography detection of an increased diameterof the optic nerve sheath (ONSD) has been considered a reliable non-invasive measure of intracranial hypertension in recent years. ONSD will be performed pror to invasive intracranial pressure(ICP) measurement in children under general anaesthesia and measurement before extubation. Ultrasound devices are widely available in ICUs, but while Transcranial Doppler sonography for the identification of cerebral circulatory arrest requires trained and skilled sonographers, ONSD evaluation, to early detect the optic nerve sheath swelling in cases of intracranial hypertension, may be performed with minimal training and, above all, non-invasively. Thus, we aimed to conduct this study to investigate whether USG measurements of ONSD could evaluate real-time ICP dynamically and sensitively. |