Effect of Cervical Collar on Intracranial Pressure

NCT ID: NCT03609879

Last Updated: 2019-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-03-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Optic Nerve Sheath Diameter Ultrasonography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

without cervical collar

baseline - without cervical collar

Group Type NO_INTERVENTION

No interventions assigned to this group

with cervical collar

scenarios with cervical collars

Group Type EXPERIMENTAL

Ambu Perfect ACE

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

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

NexSplit Plus

Intervention Type DEVICE

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

NECKLITE

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ambu Perfect ACE

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

Intervention Type 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

Intervention Type DEVICE

Necloc Collar

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

Intervention Type DEVICE

NexSplit Plus

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

Intervention Type DEVICE

NECKLITE

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wroclaw Medical University

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Lazarski University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ɓukasz Szarpak

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lukasz Szarpak

Role: PRINCIPAL_INVESTIGATOR

Lazarski University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine, Lazarski University

Warsaw, Masovian Voivodeship, Poland

Site Status

Lazarsku University

Warsaw, Masovian Voivodeship, Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26994678 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32311968 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ONSD_2018_UL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Subaxial Cervical Traumatic Injuries
NCT06297395 NOT_YET_RECRUITING
TopSpin360 in Female Varsity Athletes
NCT03844087 COMPLETED PHASE1/PHASE2