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SureCRIC Standardized Patient Study

26. oktober 2021 opdateret af: InnoVital Systems, Inc.

SureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway.

Cricothyroid membrane identification accuracy has been reported to be 30-62% in the literature [Bai15, Ell10, Kri15, Lam15]. The current study assesses SureCRIC-assisted medic performance in identifying the cricothyroid membrane in a diverse standardized patient population.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study is a two-arm, open-label study involving users - largely licensed paramedics or combat medics - identifying the cricothyroid membranes on healthy volunteers. The Control Group will perform cricothyroid membrane identification on healthy male and female volunteers of varying heights, weights, and BMI's with the standard, freehand approach. The Experimental Group will perform cricothyroid membrane identification on the volunteers with the help of the SureCRIC. An expert verifier (senior otolaryngologist) will verify correct cricothyroid membrane identification and will not be blinded in order to reduce any error that may be introduced by SureCRIC removal and subsequent skin movement. The primary endpoint is a pass/fail assessment for cricothyroid membrane identification. The main secondary endpoint is time to cricothyroid membrane identification. The study design was recommended by FDA. The study, per FDA guidance, is not designed for statistical comparisons and only descriptive statistics are provided.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20008
        • National Center for Human Factors in Healthcare

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Participants (Users):

Inclusion Criteria:

  • Paramedic or military combat medic
  • Trained to perform a cricothyrotomy

Exclusion Criteria:

  • Current or former instructor of cricothyrotomy, airway management, or anatomy
  • Experience performing cricothyrotomy on a patient in the last 6 months
  • Training on cricothyrotomy in the last 3 months
  • Previous or current participation in a study related to cricothyrotomy
  • Any condition or physical impairment that limits dexterity and/or tactile feedback
  • Performed two or more cricothyrotomies on live humans
  • Previous exposure to the SureCRIC

Healthy Volunteers (Standardized Patients):

Inclusion Criteria:

  • Less than 10th percentile height female
  • 50th percentile height female
  • Greater than 90th percentile height female
  • Less than 10th percentile height male
  • 50th percentile height male
  • Greater than 90th percentile height male

Exclusion Criteria:

  • Previous exposure to the SureCRIC
  • Age under 18 or over 60
  • Any skin condition including, but not limited to, eczema and hives
  • Skin that is thin, fragile, sensitive and/or prone to redness or irritation including skin that maintains a red, irritated appearance after the light application of pressure
  • Easy bruising or use of any blood thinning medication (including aspirin)
  • Beard on the neck
  • Use of a steroid medication by mouth or in a topical formulation like a cream or ointment
  • Any of the following chronic conditions: chronic kidney disease, chronic liver disease, coagulation disorders such as hemophilia or von Willebrand disease, low or dysfunctional platelets (e.g., thrombocytopenia), leukemia, Cushing's syndrome, Ehlers Danlos syndrome, celiac disease, any condition that causes easy bruising or sensitive or fragile skin.
  • Previous neck surgery, previous neck trauma, thyroid mass or enlargement, or other neck abnormalities
  • Any condition that would make lying supine or without a pillow painful or impossible

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SureCRIC
SureCRIC-aided cricothyroid membrane identification
Enhed: SureCRIC
SureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway.
Aktiv komparator: Freehand
Freehand cricothyroid membrane identification
Andet: Freehand
Freehand palpation approach to identification of the cricothyroid membrane

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes
Tidsramme: 1 day
pass/fail assessment for CTM identification as gauged by expert (senior orolaryngologist)
1 day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Cricothyroid Membrane Identification
Tidsramme: 1 day
time to cricothyroid membrane identification as measured by direct observation
1 day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

InnoVital Systems, Inc.

Samarbejdspartnere

Medstar Health Research Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. oktober 2017

Primær færdiggørelse (Faktiske)

27. oktober 2017

Studieafslutning (Faktiske)

27. oktober 2017

Datoer for studieregistrering

Først indsendt

23. marts 2018

Først indsendt, der opfyldte QC-kriterier

4. april 2018

Først opslået (Faktiske)

5. april 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SureCRIC_SP1
  • W81XWH-14-C-0011 (Anden identifikator: Defense Health Program)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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