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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	CTRI
Last refreshed on:	24 November 2021
Main ID:	CTRI/2016/11/007438
Date of registration:	04-11-2016
Prospective Registration:	Yes
Primary sponsor:	JIPMER postgraduate research monitoring committee
Public title:	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:	Correlation of measurement of Optic Nerve Sheath Diameter using Ultrasonography with Computed Tomography scan in Hydrocephalus patients undergoing Ventriculo-Peritoneal Shunt Surgery
Date of first enrolment:	15-11-2016
Target sample size:	60
Recruitment status:	Not Yet Recruiting
URL:	http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14598
Study type:	Observational
Study design:	Other Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded
Phase:	N/A

Countries of recruitment
India

Contacts

Name:	Dr Prasanna Udupi Bidkar
Address:	Room no 206, Department of Anesthesiology and critical care JIPMER Campus, Dhanvantri nagar, Pondicherry 605006 Mahe, PONDICHERRY India
Telephone:	9442706168
Email:	drprasannabidkar@gmail.com
Affiliation:	Jawaharlal institute of postgraduate medical education and research (JIPMER)

Name:	Dr Prasanna Udupi Bidkar
Address:	Room no 206, Department of Anesthesiology and critical care JIPMER Campus, Dhanvantri nagar, Pondicherry 605006 Pondicherry, PONDICHERRY India
Telephone:	9442706168
Email:	drprasannabidkar@gmail.com
Affiliation:	Jawaharlal institute of postgraduate medical education and research (JIPMER)

Key inclusion & exclusion criteria

Inclusion criteria: Hydrocephalus patients in the age group from 2 to 60years of age undergoing elective or emergency Ventriculo-peritoneal shunt surgery in our institute
Exclusion criteria: 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Hydrocephalus patients undergoing ventriculo-peritoneal shunt surgery

Intervention(s)

Primary Outcome(s)

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?

Timepoint: 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(s)

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.

Timepoint: All these measurements will be done in the preoperative period and after 12 hours in the post-operative period

Secondary ID(s)

NIL

Source(s) of Monetary Support

JIPMER postgraduate research monitoring committee , JIPMER, Dhanvantri Nagar, Gorimedu, Puducherry, 605006

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 22/12/2015
Contact:

Institute Ethics Committee (Human Studies), JIPMER

Results

Results available:
Date Posted:
Date Completed:
URL:

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