- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04541446
Study Dynamic Haptic Robotic Trainer (DHRT) and DHRT+ for Central Venous Catheterization Insertion Training for Residents
Studieren Sie Dynamic Haptic Robotic Trainer (DHRT) und DHRT+ für das ZVK-Einführungstraining für Assistenzärzte
Human participants will include medical residents. Each year, the entering first-year medical residents at Milton S. Hershey Medical Center and Cedars-Sinai Medical Center will be taught to perform central venous catheterization using the Dynamic Haptic Robotic Trainer (DHRT) or the Advanced Dynamic Haptic Robotic Trainer (DHRT+). The resident's performance will be measured and evaluated by these devices during training. The technique of the training does not differ from what is currently taught at either institution. Residents will be required to pass the same skills assessment currently required at their institution. Upon successfully passing the skills assessment, residents will perform central venous catheterization procedures under supervision. The investigators will examine patient files at Milton S. Hershey Medical Center to determine changes in central line-related complication and infection rates associated with the introduction of these training devices.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Pennsylvania
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Hershey, Pennsylvania, Vereinigte Staaten, 17033
- Hershey Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
First-year resident undergoing central venous catheterization training at Milton S. Hershey Medical Center or Cedars-Sinai Medical Center, at least 18 years of age
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Residents to receive Dynamic Haptic Robotic Training
First-year residents at Milton S. Hershey Medical Center or Cedars Sinai Medical Center trained using the Dynamic Haptic Robotic Trainer (DHRT), a device that trains residents to safely perform the needle insertion component of central venous catheterization." |
Device trains medical residents to safely perform the needle insertion portion of Central Venous Catheterization. |
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Experimental: Residents to receive Advanced Dynamic Haptic Robotic Training
First-year residents at Milton S. Hershey Medical Center or Cedars Sinai Medical Center trained using the Advanced Dynamic Haptic Robotic Trainer (DHRT+), which offers whole-procedure training. |
Device offers whole procedural training for medical residents to safely perform the procedure of Central Venous Catheterization. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Internal Jugular Central Venous Catheters With and Without Mechanical Complication
Zeitfenster: Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
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Mechanical complications were defined as a composite outcome including hematoma, arterial puncture, pneumothorax, hemothorax, catheter misplacement, and vessel stenosis, identified using diagnosis codes from the International Classification of Diseases that were flagged as not present at the time of hospital admission. Outcome data reflects retrospective chart review at Milton S. Hershey Medical Center. DHRT deployment began June 2021; DHRT+ began June 2022. Data collection is complete. |
Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
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Number of Internal Jugular Central Venous Catheters With and Without Thrombotic Complication
Zeitfenster: Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
Thrombotic complications were defined as venous or arterial thrombosis, including catheter-associated device thrombosis, identified using diagnosis codes from the International Classification of Diseases that were flagged as not present at the time of hospital admission. Outcome data reflects retrospective chart review at Milton S. Hershey Medical Center. DHRT deployment began June 2021; DHRT+ began June 2022. Data collection is complete. |
Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
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Number of Internal Jugular Central Venous Catheters With and Without Infectious Complication
Zeitfenster: Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
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Infectious complications were defined as a composite outcome including catheter-site infection and central line-associated bloodstream infection, identified using diagnosis codes from the International Classification of Diseases that were flagged as not present at the time of hospital admission. Outcome data reflects retrospective chart review at Milton S. Hershey Medical Center. DHRT deployment began June 2021; DHRT+ began June 2022. Data collection is complete. |
Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Scarlett R Miller, Ph.D., Penn State University
- Hauptermittler: Jason Z. Moore, Ph.D., Penn State University
- Studienleiter: Sanaz Motamedi, PhD, Penn State University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- STUDY00012206
- R01HL127316 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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