Effect of Cervical Collar on Intracranial Pressure

September 18, 2019 updated by: Łukasz Szarpak, Lazarski University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Masovian
      • Warsaw, Masovian, Poland, 02-662
        • Faculty of Medicine, Lazarski University
      • Warsaw, Masovian, Poland, 02-662
        • Lazarsku University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: without cervical collar
baseline - without cervical collar
Experimental: with cervical collar
scenarios with cervical collars
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
Device: 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
Device: Necloc Collar
patient with a fitted cervical collar (Neclock Collar) established by an experienced instructor. Cervical collar set up for 20 minutes
Device: NexSplit Plus
patient with a fitted cervical collar (NexSplit Plus) established by an experienced instructor. Cervical collar set up for 20 minutes
Device: NECKLITE
patient with a fitted cervical collar (NECKLITE) established by an experienced instructor. Cervical collar set up for 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day after
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.
1 day after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lazarski University

Collaborators

The Cleveland Clinic
Wroclaw Medical University

Investigators

  • Principal Investigator: Lukasz Szarpak, Lazarski University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

March 22, 2019

Study Completion (Actual)

March 22, 2019

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ONSD_2018_UL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Research data will be available from the principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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