| CTRI Number |
CTRI/2025/03/081723 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How does the diameter of optic nerve sheath change with the diameter of eye in patients whose pressure in head is raised |
|
Scientific Title of Study
|
Ratio of optic nerve sheath diameter to eye ball transverse diameter in patients with raised ICP by ultrasonography: a correlational 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 |
Dr PK Das |
| Designation |
Professor |
| Affiliation |
Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
| Address |
Department of Anaesthesiology and Critical Care, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7275068939 |
| Fax |
|
| Email |
drdas_73@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Digvijay Singh |
| Designation |
junior resident |
| Affiliation |
Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
| Address |
Department of Anaesthesiology and Critical Care, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9651045375 |
| Fax |
|
| Email |
samikshaparashar@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PK Das |
| Designation |
Professor |
| Affiliation |
Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
| Address |
Department of Anaesthesiology and Critical Care, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7275068939 |
| Fax |
|
| Email |
drdas_73@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Lucknow, UP 226010 |
|
|
Primary Sponsor
|
| Name |
Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
| Address |
Department of Anaesthesiology and Critical Care, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Lucknow |
| 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 Samiksha Parashar |
Dr Ram Manohar Lohia Institute of Medical Sciences |
Room no 1, Neurosurgery Ot, second floor, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Lucknow
Lucknow
UTTAR PRADESH |
7042345280
samikshaparashar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, RMLIMS, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G919||Hydrocephalus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Direct ICP measurement and ultrasound measurement |
Direct measurement of ICP by neurosurgeon at the time of ventriculostomy, and ultrasonographic measurement of eye ball transverse diameter and ONSD by anaesthesiologist |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1-3 |
|
| ExclusionCriteria |
| Details |
1. refusal to consent
2. known history of eye disease (cataract, glaucoma, tumour, trauma, any surgery)
3. any medical history that could alter the ICP |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| correlation between ONSD/ETD ratio and ICP in patients undergoing ventriculoperitoneal shunt surgery |
at the time of insertion of VP shunt |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of the correlation coefficient between ONSD and ICP vs ONSD/ETD and ICP |
at the time of insertion of VP shunt |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/11/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Measurement of ONSD has emerged as a popular tool for indirect assessment of intra cranial pressure. It has gained popularity as USG measurement of ONSD is a non- invasive, risk free, reproducible as well as point of care service. There has been multiple study with different value of ONSD suggested as cut off for increased ICP but there is no consensus among different studies. Recently a study was carried out to see, what are the different anthropometric and other variables which correlates best with ONSD in general population with no risk of increased ICP. This study correlated ONSD with sex, height, weight (head circumference and Eyeball Transverse Diameter (ETD). In their study they found that it is size of Eyeball Transverse Diameter (ETD) which correlated best with ONSD. They suggested in their final opinion that ONSD/ETD ratio might be more reliable than absolute value ONSD of as marker of raised ICP. So in this study we are planning to evaluate the correlation between ONSD/ETD ratio and direct ICP in patients coming for VP shunt surgeries. |