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

NCT ID: NCT03742427

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-06
• Study Completion Date: 2018-12-30

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.

Detailed Description

Head trauma is an important cause of morbidity and mortality. Increased intracranial pressure (ICP) can lead to decreased cerebral perfusion and tissue damage. It is important to be able to detect increased ICP on time, so that treatment can be initiated to prevent further brain damage. The measurement of optic nerve sheath diameter (ONSD) has been proposed as a non-invasive and rapid way to assess elevated ICP (1-2). Traditional ICP monitoring methods such as external ventricular devices are invasive and time-consuming and can only be performed by trained personnel at trauma centers.

The optic nerve is surrounded by a protective sheath and is found on the back of the globe. Easily evaluated with ultrasonics. This is typically done with a linear probe measuring the diameter of the optic nerve sheath 3 mm back from where the contrast is highest. The normal upper limit for adults is 5 mm, the values above are considered abnormal. Many studies have shown that an increased ONSD measured by bedside ultrasound correlates with increased IDC and in one study there is a correlation between ONSD> 5 mm and ICP> 20 cm H2O.

Cervical spine (c-arms) and cervical vertebrae are often temporarily immobilized in patients with head trauma. It has been shown that placement of c-arms increases IBP. The decrease in venous outflow caused by c-arms in the forehead is an important mechanism for this increase in ICP. The increase in ICP occurs simultaneously with the application of c-arms in cadaver. It is thought that increased ONSD in trauma patients may be related to c-arms.

If a c-collar application is found to increase ONSD, this trauma may make it difficult to use ONSD as an non-invasive estimate of ICP in patients.

To the best of our knowledge, there is a study in healthy individuals investigating the possible effect of c-collar administration on ONSD. However, there is no comparative study of patients with head trauma. The investigators tried to measure ONSD before and after placement of cervical limbs in cases with minor head trauma. The aim of our study is to identify changes in the optic nerve sheath measurement after placement of the c-arms, and to determine whether these changes are due to the time immobilized by the c-arms.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

effect of c-collar in optic nerve sheath diameter

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

Group Type: EXPERIMENTAL

ultrasonography

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

ultrasonography

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sinan Karacabey

Role: STUDY_DIRECTOR

Marmara University

Locations

Sinan Karacabey

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28865838 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28727580 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

09.2018.298

Identifier Type: -

Identifier Source: org_study_id