Effect of Cervical Collar on Intracranial Pressure

Ultrasonography Clinical Trial

Official title:

Effect of Cervical Collar on Optic Nerve Sheath Diameter Measured Sonographically. A Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03609879
• Other study ID #: ONSD_2018_UL
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: March 22, 2019

Study information

• Verified date: September 2019
• Source: Lazarski University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The routine use of cervical collar in emergency medical conditions has recently been questioned. The application of cervical collars, as their opponents point out, results in deterioration of intubation conditions, intensification of pain in the region of mastoid processes, and impaired venous outflow from the head.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• voluntary participation in the study

Exclusion Criteria:

• head or the spine injury in the last 3 months

• eye injuries in the last 3 months

• amputation of the eyeball

• Headache

Related Conditions & MeSH terms

• Optic Nerve Sheath Diameter
• Ultrasonography

Intervention

Device:
• Ambu Perfect ACE
patient with a fitted cervical collar (Ambu Perfect ACE) established by an experienced instructor. Cervical collar set up for 20 minutes
• Philly One-Peace Collar
patient with a fitted cervical collar (Philly One-Peace Collar) established by an experienced instructor. Cervical collar set up for 20 minutes
• Necloc Collar
patient with a fitted cervical collar (Neclock Collar) established by an experienced instructor. Cervical collar set up for 20 minutes
• NexSplit Plus
patient with a fitted cervical collar (NexSplit Plus) established by an experienced instructor. Cervical collar set up for 20 minutes
• NECKLITE
patient with a fitted cervical collar (NECKLITE) established by an experienced instructor. Cervical collar set up for 20 minutes

Locations

Country	Name	City	State
Poland	Faculty of Medicine, Lazarski University	Warsaw	Masovian
Poland	Lazarsku University	Warsaw	Masovian

Sponsors (3)

Lead Sponsor	Collaborator
Lazarski University	The Cleveland Clinic, Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Szarpak L, Truszewski Z, Kurowski A, Samarin S, Evrin T, Adamczyk P, Czyzewski L. Knowledge, attitude, and practices of paramedics regarding optic nerve sheath diameter ultrasonography. Am J Emerg Med. 2016 Jun;34(6):1160-1. doi: 10.1016/j.ajem.2016.02.063. Epub 2016 Mar 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic nerve sheath diameter 5 minutes after collar placement	During each evaluation with Optic nerve sheath diameter, at least three measurements were attempted from each eye. The ONSD was measured 3 mm behind the retina. All scans were performed using a 13-6 MHz linear-array probe and a high resolution optimization setting.	1 day after
Primary	Optic nerve sheath diameter 20 minutes after collar placement	During each evaluation with Optic nerve sheath diameter, at least three measurements were attempted from each eye. The ONSD was measured 3 mm behind the retina. All scans were performed using a 13-6 MHz linear-array probe and a high resolution optimization setting.	1 day after