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

NCT03742427 | Completed Results

• 1 other identifier: 09.2018.298
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head Trauma

Keywords

ultrasonography; optic nerve sheath; head trauma

Outcome Measures

Primary Outcomes (1)

• Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients

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

  20 minutes

Study Arms (1)

effect of c-collar in optic nerve sheath diameter

EXPERIMENTAL

Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography

Diagnostic Test: ultrasonography

Interventions

ultrasonography DIAGNOSTIC_TEST

optic nerve sheath diameter measurement will be done by ultrasonography on both eyes

effect of c-collar in optic nerve sheath diameter

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with minor head trauma
• Patients over 18 years and under 65 years
• Those who signed the Informed Consent Form

You may not qualify if:

• Patients who can not be followed for any reason (treatment, refusal, unauthorized leave, referral to the center, etc.)
• Patients who withdraw their consent

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Sinan Karacabey

Istanbul, 34687, Turkey (Türkiye)

Location

Related Publications (2)

• Woster CM, Zwank MD, Pasquarella JR, Wewerka SS, Anderson JP, Greupner JT, Motalib S. Placement of a cervical collar increases the optic nerve sheath diameter in healthy adults. Am J Emerg Med. 2018 Mar;36(3):430-434. doi: 10.1016/j.ajem.2017.08.051. Epub 2017 Aug 26.

  PMID: 28865838 BACKGROUND

• Maissan IM, Ketelaars R, Vlottes B, Hoeks SE, den Hartog D, Stolker RJ. Increase in intracranial pressure by application of a rigid cervical collar: a pilot study in healthy volunteers. Eur J Emerg Med. 2018 Dec;25(6):e24-e28. doi: 10.1097/MEJ.0000000000000490.

  PMID: 28727580 BACKGROUND

MeSH Terms

Conditions

Craniocerebral Trauma

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Sinan KARACABEY
• Organization: Marmara University

karacabeysinan@gmail.com

+902166254545

Study Officials

• Sinan Karacabey

  Marmara University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: November 15, 2018
• Study Start: May 6, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: June 18, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)