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NCT03742427

Effect of Cervical Collar on the Optic Nerve Sheath Diameter in Minor Head Trauma

Completed NA Results posted Last updated 18 June 2021
What this trial tests

NA trial testing ultrasonography in Head Trauma in 50 participants. Completed in 30 December 2018.

Timeline
6 May 2018
Primary endpoint
30 December 2018
30 December 2018

Quick facts

Lead sponsorMarmara University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment50
Start date6 May 2018
Primary completion30 December 2018
Estimated completion30 December 2018
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Marmara University

Who can join

Adults 18 to 65, any sex, with Head Trauma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients Primary · 20 minutes

We hypothesised that optic nerve sheath diameter raises after c-collar application in minor head trauma patients

0th Minute
GroupValue95% CI
Effect of C-collar in Optic Nerve Sheath Diameter4.71± 0.22
5th minute
GroupValue95% CI
Effect of C-collar in Optic Nerve Sheath Diameter5.19± 0.41
20th minute
GroupValue95% CI
Effect of C-collar in Optic Nerve Sheath Diameter5.26± 0.45

Sponsor's own description

This is randomized, controlled and blinded study was performed in minor head trauma patients. Two sonographers measured optic nerve sheath diameters (ONSD) of each subjects' eyes separately for different time points. Then a mean ONSD was calculated for before c-collar placement (T0), 5 and 20 minutes in supine position.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of ultrasonography

Trials testing the same drug.

Other recruiting trials for Head Trauma

Currently open trials in the same condition.

Other Marmara University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing