- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02665767
Telementoring for Identifying the Appendix Using Telesonography (TIAT)
A Feasibility Study of Telementoring for Identifying the Appendix Using Smartphone-based Telesonography
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A randomized cross-over study was conducted using a telesonography system that can transmit the ultrasound images displayed on the ultrasound monitor(ultrasound sequence video) and images showing the practitioner's operations(background video) to a smartphone without any interruption in motion over a Long Term Evolution (LTE) network. Thirty novice practitioners were randomly assigned to two groups. The subjects in group A (n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert, whereas those in group B (n=15) performed the same procedure under mentoring by an offsite expert.
Each subject performed the procedure on three simulated patients. After a four-week interval, they performed the procedure again under the other type of mentoring. A total of 90 ultrasound examinations were performed in each scenario. The primary outcomes were the success rate for identifying the appendix and the time required to identify the appendix.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Gyeonggi-do
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Guri-si, Gyeonggi-do, Korea, Republikken, 471-701
- Hanyang University Guri Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Without any experience in ultrasonography
Exclusion Criteria:
- Subjects who do not want to participate
- Subjects who has eye pain or any eye problem
- Subjects who has wrist pain
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: On-site sonography
The subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert.
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Aktiv komparator: Smartphone-based Telesonography
The subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an offsite expert.
|
The 30 participating examiners were randomly divided into two groups.
In phase one, group A performed ultrasonography under onsite mentoring and group B performed the same procedure under remote mentoring.
Each examiner was randomly assigned one expert and three SPs for phase one.
Four weeks later, they were partnered with the same expert and SPs to whom they had been assigned in phase one and performed the procedure under the other type of mentoring (phase two).
The examination order of the SPs was randomly assigned by choosing a number between one and six (1: A-B-C, 2: A-C-B, 3: B-A-C, 4: B-C-A, 5: C-A-B, 6: C-B-A) in each phase.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Success rate
Tidsramme: 8 months
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"Success" is meaning of identifying appendix in 10 minutes.
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8 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Time to identifying appendix
Tidsramme: 8 months
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8 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: YOONJE LEE, M.D., Departement of Emergency Medicine, Hanyang University Guri Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Hanyang University
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