A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device
14. august 2017 oppdatert av: Yonsei University
Two-dimensional ultrasound guided approach does not guarantee first attempt success on internal jugular vein cannulation.
New attachable device recently was developed for accurate needle insertion when ultrasound is used.
Our randomized parallel simulation study will examine whether this device will improve the first attempt success rate when ultrasound guided internal jugular vein catheterization of simulated internal jugular vein.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This was a prospective, randomized, parallel trial using phantom simulating internal jugular vein.
After informed consent all subjects will be randomized to insert needle for internal jugular vein cannulation of phantom using ultrasound approach with or without this device. Video camera will record all procedure process and ultrasound image in real time. Researchers blinded to the study aim measured outcome variables based on recorded images.
Studietype
Intervensjonell
Registrering (Faktiske)
88
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Seoul, Korea, Republikken, 03722
- Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Adults over 20
- Resident in clinical hospital
- Ultrasound-guided internal jugular vein insertion without supervisor experience less than 10
Exclusion Criteria:
- If they have physical problem that is difficult to perform
- If they do not want to participate in this study
- If they can not understand the contents reading the informed consent
- If they have more than 10 ultrasound guided internal jugular vein insertion without supervisor
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: New device group
participants who are tested performance for ultrasound guided cannulation using device
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Study subjects assigned to each group were trained in ultrasound guided internal jugular venous cannulation (UGIJVC) in separate spaces.
On each session, subjects were educated about UGIJVC for 30 minutes, and the instructor who was in charge of session, consisted of experienced physicians who had 50 or more UGIJVC success experiences without a supervisor in clinical field.
The instructors explained the anatomical structure and the principles of UGIJVC and then demonstrated the procedures directly to the subjects using phantom.
After that, all subjects were instructed to perform hands on practice for 30 minutes.
In case group, the instructor trained subjects using device.
On the other hand in control group, UGIVJC was demonstrated as a conventional method of approaching the target vessel while confirming the needle tip on the ultrasound screen in real time without a device.
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Aktiv komparator: Conventional group
participants who are tested performance for ultrasound guided cannulation using conventional method
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participants who are tested performance for ultrasound guided cannulation using conventional method.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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First attempt success
Tidsramme: Within 2 minutes or after start to insertion attempt
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The first attempt success was defined as a successful attempt to perform a vein puncture in one attempt.
The number of attempts was counted each time a subject inserted a guide needle into the phantom surface, followed by withdrawal, redirect, or reinsertion.
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Within 2 minutes or after start to insertion attempt
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Posterior wall puncture of the internal jugular procedure, comfort level with procedure
Tidsramme: Within 2 minutes or after start to insertion attempt
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It was defined when the needle tip on the recorded ultrasound screen was confirmed to pass through the posterior wall measurement unit : Yes or no (categorical variable)
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Within 2 minutes or after start to insertion attempt
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Carotid artery puncture
Tidsramme: Within 2 minutes or after start to insertion attempt
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It was defined as the needle tip passing through the carotid lumen or the subject regurgitating artery water during cannulation attempt. measurement unit : Yes or no (categorical variable) |
Within 2 minutes or after start to insertion attempt
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Time to cannulation
Tidsramme: Within 2 minutes or after start to insertion attempt
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It was defined as the time from time out for procedure start to end point measurement unit : second
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Within 2 minutes or after start to insertion attempt
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Comfort level
Tidsramme: Within 2 minutes or after start to insertion attempt
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It was defined subjective opinion about difficulty during procedure for each subject measurement unit : 100-mm visual analogue scale with 0 being the least of the difficulties and 10 being the highest.
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Within 2 minutes or after start to insertion attempt
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. mars 2017
Primær fullføring (Faktiske)
24. juni 2017
Studiet fullført (Faktiske)
24. juni 2017
Datoer for studieregistrering
Først innsendt
28. juli 2017
Først innsendt som oppfylte QC-kriteriene
14. august 2017
Først lagt ut (Faktiske)
17. august 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1-2016-0081
Legemiddel- og utstyrsinformasjon, studiedokumenter
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