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

Primary Purpose

Head Trauma

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ultrasonography
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head Trauma focused on measuring ultrasonography, optic nerve sheath, head trauma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sinan Karacabey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

effect of c-collar in optic nerve sheath diameter

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 25, 2018
Last Updated
June 16, 2021
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT03742427
Brief Title
Effect of Cervical Collar on the Optic Nerve Sheath Diameter in Minor Head Trauma
Official Title
Effect of Cervical Collar on the Optic Nerve Sheath in Minor Head Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 6, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Trauma
Keywords
ultrasonography, optic nerve sheath, head trauma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
effect of c-collar in optic nerve sheath diameter
Arm Type
Experimental
Arm Description
Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasonography
Intervention Description
optic nerve sheath diameter measurement will be done by ultrasonography on both eyes
Primary Outcome Measure Information:
Title
Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients
Description
We hypothesised that optic nerve sheath diameter raises after c-collar application in minor head trauma patients
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinan Karacabey
Organizational Affiliation
Marmara University
Official's Role
Study Director
Facility Information:
Facility Name
Sinan Karacabey
City
Istanbul
ZIP/Postal Code
34687
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28865838
Citation
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.
Results Reference
background
PubMed Identifier
28727580
Citation
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.
Results Reference
background

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

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