NCT03609879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

July 25, 2018

Last Update Submit

September 18, 2019

Conditions

Optic Nerve Sheath DiameterUltrasonography

Keywords

cervical collarsonographyadult patientsOptic nerve sheath diameterUltrasonography

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

without cervical collar

NO INTERVENTION

baseline - without cervical collar

with cervical collar

EXPERIMENTAL

scenarios with cervical collars

Device: Ambu Perfect ACEDevice: Philly One-Peace CollarDevice: Necloc CollarDevice: NexSplit PlusDevice: NECKLITE

Interventions

Ambu Perfect ACEDEVICE

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

with cervical collar
Philly One-Peace CollarDEVICE

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

with cervical collar
Necloc CollarDEVICE

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

with cervical collar
NexSplit PlusDEVICE

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

with cervical collar
NECKLITEDEVICE

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

with cervical collar

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • voluntary participation in the study

You may not qualify if:

  • head or the spine injury in the last 3 months
  • eye injuries in the last 3 months
  • amputation of the eyeball
  • Headache

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Medicine, Lazarski University

Warsaw, Masovian Voivodeship, 02-662, Poland

Location

Lazarsku University

Warsaw, Masovian Voivodeship, 02-662, Poland

Location

Related Publications (2)

  • 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. No abstract available.

    PMID: 26994678BACKGROUND

  • Ladny M, Smereka J, Ahuja S, Szarpak L, Ruetzler K, Ladny JR. Effect of 5 different cervical collars on optic nerve sheath diameter: A randomized crossover trial. Medicine (Baltimore). 2020 Apr;99(16):e19740. doi: 10.1097/MD.0000000000019740.

    PMID: 32311968DERIVED

Study Officials

  • Lukasz Szarpak

    Lazarski University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 1, 2018

Study Start

August 1, 2018

Primary Completion

March 22, 2019

Study Completion

March 22, 2019

Last Updated

September 20, 2019

Record last verified: 2019-09

Locations

PL(2)