- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07670637
Blended vs Conventional Training for ACLS
25. juni 2026 opdateret af: Min Ding, Shanghai East Hospital of Tongji University
Blended Learning Approach Versus Conventional Training in Advanced Cardiovascular Life Support Training: A Randomized Controlled Trial With Cost-Effectiveness Analysis
The investigators conducted a stratified randomized controlled trial with an embedded cost-effectiveness analysis at a tertiary hospital in China.
Participants were randomized to either traditional instructor-led ACLS training (ILT ACLS) or blended-learning HeartCode ACLS training (HC ACLS).
The primary outcome was the overall first-attempt ACLS certification pass rate.
A cost-effectiveness analysis was conducted from the institutional perspective using certification pass rate as the effectiveness measure.
Costs estimation included program delivery costs and productivity losses associated with participant training time.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
95
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200120
- Shanghai East Hospital Affiliated To Tongji University
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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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Second-year resident physicians and nurses
- Working in the emergency, critical care, or anesthesiology departments
- Valid Basic Life Support (BLS) certification
- No prior Advanced Cardiovascular Life Support (ACLS) training
- Physical ability to perform chest compressions, bag-mask ventilation, and defibrillation
- Willing and able to provide written informed consent
Exclusion Criteria:
- Individuals without a valid BLS certification
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: HeartCode ACLS
Participants received blended-learning HeartCode ACLS training, which combines online self-paced modules with hands-on practice sessions.
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A blended-learning ACLS course combining online HeartCode self-paced modules with instructor-facilitated hands-on practice sessions.
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Aktiv komparator: Instructor-Led ACLS Training
Participants received traditional instructor-led ACLS training (ILT ACLS) delivered entirely in-person by certified instructors.
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A traditional, entirely in-person ACLS course delivered by certified instructors, following standard American Heart Association (AHA) guidelines, without online pre-learning components.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall First-Attempt ACLS Certification Pass Rate
Tidsramme: Up to 2 days.
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The proportion of participants who pass the ACLS certification examination on their first attempt after completing the assigned training program.
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Up to 2 days.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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First-Attempt Pass Rate for Individual Assessments
Tidsramme: Up to 2 days.
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Proportion of participants who pass each of the three individual assessments (high-quality BLS, airway management, and Megacode) on the first attempt.
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Up to 2 days.
|
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CPR Quality - Compression Depth
Tidsramme: Up to 2 days.
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Mean chest compression depth (mm) recorded during Megacode assessment, measured by high-fidelity manikin with QCPR technology.
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Up to 2 days.
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CPR Quality - Compression Rate
Tidsramme: Up to 2 days.
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Mean chest compression rate (compressions per minute) recorded during Megacode assessment.
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Up to 2 days.
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CPR Quality - Chest Recoil
Tidsramme: Up to 2 days.
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Proportion of compressions with adequate chest recoil (percentage) recorded during Megacode assessment.
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Up to 2 days.
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Training Cost per Participant
Tidsramme: Through study completion, an average of 6 months.
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Mean total training cost per participant (in RMB), including program delivery costs (equipment, facilities, materials, personnel) and productivity losses.
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Through study completion, an average of 6 months.
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Participant Satisfaction
Tidsramme: Up to 2 days.
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Learner satisfaction measured using the AHA ACLS Classroom Course Evaluation Form, completed immediately after course completion.
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Up to 2 days.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Min Ding, MMED, Department of Post-Graduate Education, Shanghai East Hospital, Tongji University School of Medicine
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)
1. juli 2024
Primær færdiggørelse (Faktiske)
31. december 2024
Studieafslutning (Faktiske)
31. december 2024
Datoer for studieregistrering
Først indsendt
16. juni 2026
Først indsendt, der opfyldte QC-kriterier
25. juni 2026
Først opslået (Faktiske)
26. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2024YS-296
- 2026-0345-YB-05 (Andet bevillings-/finansieringsnummer: Tongji University)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data (IPD) will not be shared because the informed consent did not include provisions for data sharing.
Additionally, data sharing is restricted by applicable Chinese privacy laws (Personal Information Protection Law) regarding personal performance data.
Given the single-center design and moderate sample size, the generalizability of the data is limited, and the study does not involve investigational products or regulatory submission.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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