- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07670637
Blended vs Conventional Training for ACLS
25. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
95
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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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200120
- Shanghai East Hospital Affiliated To Tongji University
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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
- Voksen
- Eldre voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
First-Attempt Pass Rate for Individual Assessments
Tidsramme: Up to 2 days.
|
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.
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Min Ding, MMED, Department of Post-Graduate Education, Shanghai East Hospital, Tongji University School of Medicine
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)
1. juli 2024
Primær fullføring (Faktiske)
31. desember 2024
Studiet fullført (Faktiske)
31. desember 2024
Datoer for studieregistrering
Først innsendt
16. juni 2026
Først innsendt som oppfylte QC-kriteriene
25. juni 2026
Først lagt ut (Faktiske)
26. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2024YS-296
- 2026-0345-YB-05 (Annet stipend/finansieringsnummer: Tongji University)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .