| CTRI Number |
CTRI/2016/11/007438 [Registered on: 04/11/2016] Trial Registered Prospectively |
| Last Modified On: |
04/11/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trail to measure Optic nerve sheath diameter by ultrasound and computed tomography scan and compare these values among the patient who have enlarged brain space and are undergoing Ventriculo-peritoneal shunt surgery. |
|
Scientific Title of Study
|
Correlation of measurement of Optic Nerve Sheath Diameter using Ultrasonography with Computed Tomography scan in Hydrocephalus patients undergoing Ventriculo-Peritoneal Shunt Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Bhandari |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research (JIPMER) |
| Address |
Room 311, Harvey hostel 2
JIPMER campus, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9655613608 |
| Fax |
|
| Email |
deepak.bhandari@jipmer.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Udupi Bidkar |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research (JIPMER) |
| Address |
Room no 206, Department of Anesthesiology and critical care
JIPMER Campus, Dhanvantri nagar, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442706168 |
| Fax |
|
| Email |
drprasannabidkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanna Udupi Bidkar |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research (JIPMER) |
| Address |
Room no 206, Department of Anesthesiology and critical care
JIPMER Campus, Dhanvantri nagar, Pondicherry
Mahe
PONDICHERRY
605006
India |
| Phone |
9442706168 |
| Fax |
|
| Email |
drprasannabidkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER postgraduate research monitoring committee , JIPMER, Dhanvantri Nagar, Gorimedu, Puducherry, 605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER postgraduate research monitoring committee |
| Address |
Second floor, Institute block, JIPMER, Puducherry , India |
| Type of Sponsor |
Government medical college |
|
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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 Deepak Bhandari |
Emergecy operation theater, Department of Anesthesiology and critical care |
Second floor, EMS block, Department of Anesthesiology, JIPMER campus
Pondicherry
PONDICHERRY |
9655613608
deepak.bhandari@jipmer.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human Studies), JIPMER |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hydrocephalus patients undergoing ventriculo-peritoneal shunt surgery , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Hydrocephalus patients in the age group from 2 to 60years of age undergoing elective or emergency Ventriculo-peritoneal shunt surgery in our institute |
|
| ExclusionCriteria |
| Details |
Revision surgery, patients with eye injury, Patients with a history of optic neuritis, arachnoid cyst of the optic nerve, high myopia, optic nerve trauma, and anterior orbital or cavernous sinus mass will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) What is the level of correlation of optic nerve sheath diameter in Ultrasound and CT Scan among the patients undergoing Ventriculoperitoneal shunt surgery?
b) Is there any association between ONSD and clinical features among the patients undergoing VPS surgery?
c) What is the level of agreement between USG and CT in the measurement of ONSD?
|
The optic nerve sheath diameter will be measured in CT scan and ultrasound in the preoperative period and 12 hours after shunt insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the ONSD using USG and CT in patients undergoing VPS surgery.
2. To identify the association of the ONSD with clinical factors among the patients undergoing VPS surgery.
3. To identify the level of agreement between USG and CT on the measurement of ONSD in patients undergoing surgery.
|
All these measurements will be done in the preoperative period and after 12 hours in the post-operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/11/2016 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an observational study comparing optic nerve sheath diameter measured by ultrasonography and computed tomography in 60 hydrocephalus patients undergoing ventriculo-peritoneal shunt surgery. The primary outcome measure will be the optic nerve sheath diameter measurement preoperatively and 12 hours after the surgery by both ultrasonography and computed tomography. The correlation among the measurement by ultrasonogphy and computed tomography will be measured. The secondary outcome will be to identify the association of the ONSD with clinical factors among the patients undergoing VPS surgery after 12 hours. |