Head Trauma Clinical Trial
Official title:
Effect of Cervical Collar on the Optic Nerve Sheath in Minor Head Trauma Patients
Verified date | May 2021 |
Source | Marmara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 30, 2018 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Sinan Karacabey | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 20 minutes |
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