CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Ultrasonographic of the optic nerve sheath diameter +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02361658
NCT02361658N/ACompleted

Ultrasonographic Assessment of the Optic Nerve Sheath Diameter During Variations in PetCO2 and Controlled Internal Jugular Venous Occlusion: A Volunteer Study

Lashmi Venkatraghavan·observational·Posted Feb 12, 2015·Updated Mar 17, 2025

In Brief

An observational study evaluating Ultrasonographic of the optic nerve sheath diameter, RespirAct™, and 1 other intervention for Elevated Intracranial Pressure (ICP). Completed, enrolled 100 participants across 1 site.

Detailed Summary

Monitoring the ICP is the most important aspect of the management of these patients. Recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be useful in the diagnosis of raised ICP by evaluating the change in the optic nerve sheath diameter (ONSD). Transorbital ultrasonographic measurement of ONSD appears to be a noninvasive, relatively inexpensive bedside examination for the diagnosis of raised ICP. The investigators aimed to determine the changes in ONSD with acute controlled changes in ICP in healthy volunteers. The controlled changes in ICP will be produced by manipulating the PCO2 with the use of Respiract and jugular venous compression with the use of custom made neck collar.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 12, 2015
Enrollment StartJan 1, 2015
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.4 years ago

Interventions

Ultrasonographic of the optic nerve sheath diameterother

On both eyes of all subjects in supine position by two investigators.

RespirAct™other

Carbon dioxide Manipulation by RespirAct™ sequential gas delivery breathing circuit at each CO2 levels (normocapnia, Hypercapnia I and II and hypocapnia).

Neck collarother

Internal jugular compression using a Neck collar will be applied at each CO2 levels (normocapnia, Hypercapnia I and II and hypocapnia) and ONSD measurements will be done before and after the collar.