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OpenTrials
Completed

NCT Number: NCT03609879

Effect of Cervical Collar on Intracranial Pressure

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.

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Key information

Conditions

Optic Nerve Sheath Diameter Ultrasonography

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Lazarski University, Warsaw, Masovian Voivodeship, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambu Perfect ACE

Device

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

Device

patient with a fitted cervical collar (Philly One-Peace Collar) established by an experienced instructor. Cervical collar set up for 20 minutes

Necloc Collar

Device

patient with a fitted cervical collar (Neclock Collar) established by an experienced instructor. Cervical collar set up for 20 minutes

NexSplit Plus

Device

patient with a fitted cervical collar (NexSplit Plus) established by an experienced instructor. Cervical collar set up for 20 minutes

NECKLITE

Device

patient with a fitted cervical collar (NECKLITE) established by an experienced instructor. Cervical collar set up for 20 minutes

Primary outcomes

  1. Optic nerve sheath diameter 5 minutes after collar placement

    Time frame: 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.

  2. Optic nerve sheath diameter 20 minutes after collar placement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lazarski University

Other

Collaborators

  • The Cleveland Clinic
  • Wroclaw Medical University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2018
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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