Effect of Cervical Collar on Intracranial Pressure

Not Applicable

Completed

• Conditions: Optic Nerve Sheath Diameter; Ultrasonography
• Interventions: Device: Ambu Perfect ACE; Device: Philly One-Peace Collar; Device: Necloc Collar; Device: NexSplit Plus; Device: NECKLITE

• Registration Number: NCT03609879
• Lead Sponsor: Lazarski University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-07-25
• Study Start: 2018-08-01
• Study First Posted: 2018-08-01
• Primary Completion: 2019-03-22
• Study Completion: 2019-03-22
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
with cervical collar	Necloc Collar	scenarios with cervical collars
with cervical collar	Philly One-Peace Collar	scenarios with cervical collars
with cervical collar	Ambu Perfect ACE	scenarios with cervical collars
with cervical collar	NexSplit Plus	scenarios with cervical collars
with cervical collar	NECKLITE	scenarios with cervical collars

Primary Outcome Measures

Name	Time	Method
Optic nerve sheath diameter 5 minutes after collar placement	1 day after	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.
Optic nerve sheath diameter 20 minutes after collar placement	1 day after	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.

Trial Locations

Locations (2)

Faculty of Medicine, Lazarski University; 🇵🇱 Warsaw, Masovian, Poland

Lazarsku University; 🇵🇱 Warsaw, Masovian, Poland