A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device
14 augusti 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
88
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Seoul, Korea, Republiken av, 03722
- Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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First attempt success
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Posterior wall puncture of the internal jugular procedure, comfort level with procedure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 mars 2017
Primärt slutförande (Faktisk)
24 juni 2017
Avslutad studie (Faktisk)
24 juni 2017
Studieregistreringsdatum
Först inskickad
28 juli 2017
Först inskickad som uppfyllde QC-kriterierna
14 augusti 2017
Första postat (Faktisk)
17 augusti 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 augusti 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 augusti 2017
Senast verifierad
1 augusti 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1-2016-0081
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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