Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Opfølgningsundersøgelse, der validerer en blandet teknik

22. april 2026 opdateret af: Vidacare Corporation

En opfølgningsundersøgelse, der validerer en blandet teknik til identifikation af det proksimale Humerus Intraosseous Vascular Access Insertion Site

En opfølgningsundersøgelse, der validerer en blandet teknik til identifikation af det proksimale Humerus Intraosseous Vascular Access Insertion Site

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

I 2012 evaluerede efterforskerne fra Vidacare 4 teknikker, der almindeligvis anvendes til at identificere det proksimale humerus IO-indføringssted for at afgøre, om en teknik resulterede i en mere konsekvent vellykket placering af IO-nålesættet med et højere niveau af tillid blandt enhedsoperatører, der udfører teknikkerne. Resultater tyder på, at en kombination af de bedste egenskaber ved de 4 teknikker kan føre til optimal IO-nålesætplacering mere konsekvent. Denne undersøgelse er nødvendig for at validere den "blandede" proksimale humerus IO indsættelsesteknik for at bekræfte, at brugen af ​​teknikken resulterer i korrekt stedidentifikation blandt enhedsoperatører og resulterer i øget tillid. modtaget af klinikere, der udfører disse procedurer på faktiske patienter, vil enhedsoperatører omfatte licenserede/certificerede klinikere, herunder akutmedicinske teknikere/paramedicinere og sygeplejersker.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Texas
      • Spring Branch, Texas, Forenede Stater, 78070
        • Bulverde-Spring Branch EMS

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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • Aktuelt licenserede/certificerede akutmedicinske teknikere, paramediciner eller sygeplejerske Har ikke haft nogen formel træning i brugen af ​​det proksimale humerus IO-indføringssted Demonstrer korrekt brug af enheden og teknikken under træningsdelen og indhent godkendelse fra enhedstræneren til at deltage

Ekskluderingskriterier:

  • Tidligere træning i etablering af proximal humerus intraossøs vaskulær adgang

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Blended Technique for Intraosseous Insertion
Clinician device operators will be trained on the Blended Technique site identification method and perform one unilateral proximal humerus (PH) intraosseous needle insertion. The blended technique is: The arm is positioned with the elbow adducted and shoulder internally rotated with the hand over the abdomen. The operator places one hand in the axilla and the other hand along the midline of the upper arm laterally, to define the anterior and posterior borders. The vertical plane of insertion lies in the middle of these borders. Along the vertical axis, deeply palpate the PH until the junction of the surgical neck and humeral head is identified. The insertion site is the greater tubercle, about 1-2 cm superior to the surgical neck. Secondary confirmation is made by palpating the inter-tubercular groove with a 90º rotation of the arm, confirming the insertion site is lateral to the groove, and returning the arm back to a medially rotated position with the hand over the abdomen
Enhed: Intraosseous Vascular Access
Intraossesous Vascular Access in the proximal humerus
Andre navne:
  • EZ-IO
  • IO
  • Proksimal Humerus IO-adgang
Andet: Healthy Subjects: Blended Technique
Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.
Enhed: Intraosseous Vascular Access
Intraossesous Vascular Access in the proximal humerus
Andre navne:
  • EZ-IO
  • IO
  • Proksimal Humerus IO-adgang

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score
Tidsramme: Day 1 Within 10 minutes following procedure

X-ray images of the inserted IO needle will be used to evaluate placement success and scored. Each insertion is scored by a musculoskeletal radiologist for two measures: Insertion Site Accuracy (scale range 0 - 3) and Needle Tip Location (scale range -7 to 7) as described below.

The Total score is the sum of Insertion Site Accuracy Score and Needle Tip Location Score. Scale range -7 to 10; higher score indicates greater accuracy.

Insertion Site Accuracy Score Scale is 0 to 3 where higher scores indicate greater accuracy: 3=center of greater tubercle, 2=perimeter of greater tubercle, 1=junction of greater tubercle and shaft or head, and 0=outside the greater tubercle.

Needle tip Location Score Scale ranges from -7 to 7 where higher scores indicate more favorable needle tip location: 7=within center of proximal humerus (PH), 5=within PH not centered, 3= Near miss of PH, -3=In humeral head, -3=on epiphyseal line, -5=lateral miss (of the humerus), -7=medial miss (of the humerus).
Day 1 Within 10 minutes following procedure
Time to Intraosseous Catheter Placement
Tidsramme: 1 day, within 10 minutes of procedure
The amount of time it takes for the device operator to identify the proximal humerus intraosseous (IO) insertion site using their assigned proximal humerus IO site identification method and insert the IO needle. Timing starts from the time the participant begins to palpate the proximal humerus and stops when the IO needle is inserted.
1 day, within 10 minutes of procedure
Level of Confidence Score Pre-intraosseous Insertion
Tidsramme: Day 1 within 10 minutes of completing training
Device operators scored their perceived Level of Confidence with their assigned Intraosseous (IO) Insertion method. The score was reported following the completion of training but before performing the unilateral IO insertion. The Level of Confidence scale scores range from 1 to 5, where. 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=very confident, and 5=extremely confident. Higher scores indicate greater level of confidence.
Day 1 within 10 minutes of completing training
Level of Confidence Score Post-intraosseous Insertion
Tidsramme: Day 1 within 10 minutes of completing the unilateral intraosseous insertion
Device operators scored their perceived Level of Confidence with their assigned Intraosseous (IO) Insertion method for their one unilateral proximal humerus IO site procedure. The score was reported after performing the unilateral IO insertion. The Level of Confidence scale scores range from 1 to 5, where. 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=very confident, and 5=extremely confident. Higher scores indicate greater level of confidence.
Day 1 within 10 minutes of completing the unilateral intraosseous insertion
Ease of Use Score Pre-intraosseous Insertion
Tidsramme: Day 1 within 10 minutes of completing the unilateral intraosseous insertion
Device operators will score their perceived Ease of Use for their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The score was reported following the completion of training but before performing the unilateral IO insertion. The Ease of Use scale scores range from 1 to 5, where 1=very difficult, 2=difficult, 3=neutral, 4=easy, and 5=very easy. Higher scores indicate greater ease of use.
Day 1 within 10 minutes of completing the unilateral intraosseous insertion
Ease of Use Score Post-intraosseous Insertion
Tidsramme: Day 1 within 10 minutes of completing the unilateral insertion
Device operators will score their perceived Ease of Use for their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The score was reported after completing the unilateral intraosseous insertion. The Ease of Use scale scores range from 1 to 5, where 1=very difficult, 2=difficult, 3=neutral, 4=easy, and 5=very easy. Higher scores indicate greater ease of use.
Day 1 within 10 minutes of completing the unilateral insertion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraosseous Infusion Flow Rates
Tidsramme: Day 1 after establishing IO vascular access
Intraosseous infusion flow rates attained at tested infusion pressures, which may include Gravity; 100 mmHg, 200 mmHg and 300 mmHg.
Day 1 after establishing IO vascular access
Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart
Tidsramme: Day 1 after IO insertion
Time in seconds for fluid delivery from the proximal humerus to the heart, using visualization of contrast injection under fluoroscopy was performed and measured once for the participants in the Healthy Subjects: Blended Technique arm.
Day 1 after IO insertion
Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens
Tidsramme: Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access
Number of Participants with Laboratory Results Successfully Obtained from both intraosseous (IO) and peripheral venous blood specimens. Success was determined if the point-of-care laboratory analysis system provided laboratory results values for both IO and Peripheral Venous specimens. It was deemed unsuccessful if the point-of-care system provided no laboratory results values and/or noted an error for at least one specimen. An intraosseous blood specimen and a peripheral venous blood specimen were collected from each subject
Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access

Samarbejdspartnere og efterforskere

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

Sponsor

Vidacare Corporation

Efterforskere

  • Ledende efterforsker: Larry J Miller, MD, Vidacare Corporation

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

1. maj 2013

Primær færdiggørelse (Faktiske)

1. maj 2013

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

28. maj 2013

Først indsendt, der opfyldte QC-kriterier

30. maj 2013

Først opslået (Anslået)

31. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. april 2026

Sidst verificeret

1. maj 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2013-06 (AP HM)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

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 .

Kliniske forsøg med Vaskulær adgang

Kliniske forsøg med Intraosseous Vascular Access

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mongolia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner