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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03742427
Enrollment
50
Registered
2018-11-15
Start date
2018-05-06
Completion date
2018-12-30
Last updated
2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Trauma

Keywords

ultrasonography, optic nerve sheath, head trauma

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.

Interventions

DIAGNOSTIC_TESTultrasonography

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

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients20 minutesWe hypothesised that optic nerve sheath diameter raises after c-collar application in minor head trauma patients

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
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 ultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes
50
Total50

Baseline characteristics

CharacteristicEffect of C-collar in Optic Nerve Sheath Diameter
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
50 Participants
Age, Continuous39.44 years
STANDARD_DEVIATION 6.56
Optic Nerve Sheath Diameter4.71 milimeters
STANDARD_DEVIATION 0.22
Race and Ethnicity Not Collected— Participants
Region of Enrollment
Turkey
50 participants
Sex: Female, Male
Female
20 Participants
Sex: Female, Male
Male
30 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 50
other
Total, other adverse events
0 / 50
serious
Total, serious adverse events
0 / 50

Outcome results

Primary

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

Time frame: 20 minutes

ArmMeasureGroupValue (MEAN)Dispersion
Effect of C-collar in Optic Nerve Sheath DiameterSonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients20th minute5.26 MilimeterStandard Deviation 0.45
Effect of C-collar in Optic Nerve Sheath DiameterSonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients0th Minute4.71 MilimeterStandard Deviation 0.22
Effect of C-collar in Optic Nerve Sheath DiameterSonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients5th minute5.19 MilimeterStandard Deviation 0.41

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026