- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00919308
Simulation Training for Ultrasound Guided Central Venous Catheter Insertion
Hypothesis #1: Residents who complete a structured, ultrasound guided simulation training protocol will have superior skills at central venous catheter (CVC) insertion on actual patients as compared to residents who are trained in CVC insertion according to the traditional, bedside apprenticeship model as measured by a reduced failure rate at CVC insertion.
Hypothesis #2: Residents who complete a structured, ultrasound guided simulation training protocol will have superior skills at CVC insertion on actual patients as compared to residents who are trained in CVC insertion according to the traditional, bedside apprenticeship model as measured by:
- a reduced number of attempts at venous cannulation,
- a decreased rate of technical errors and a decreased complication rate based on an independent rater's evaluation using a procedure checklist, and
- a decreased time to CVC insertion from opening the catheter kit to placement of sterile dressing as timed by an independent rater.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Connecticut
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New Haven, Connecticut, États-Unis, 06520
- Yale-New Haven Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Eligibility is determined by the program director of the residency programs.
- The racial, gender, and ethnic characteristics of the proposed subject population reflects the demographics of the interns and residents within the specialties of Emergency Medicine, Internal Medicine, General Surgery, Obstetrics and Gynecology and Anesthesia.
- None of the subjects are minors and all are in sufficient health to participate in their residency programs.
Exclusion Criteria:
- Of eligible subjects, the only exclusion criterion is unwillingness to participate in the project.
- No exclusion criteria shall be based on race, gender, or ethnicity.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Control, traditional bedside training
Postgraduate year 1 and 2 residents who are trained in central venous catheter insertion according to the traditional, bedside apprenticeship model.
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Simulation training
Postgraduate year 1 and 2 residents who complete a hands-on ultrasound guided simulation training protocol on a partial task training simulator until competence is achieved as measured by: the ability to cannulate a simulated vein under ultrasound guidance on first pass in five consecutive attempts and correct insertion of a central venous cannulator on a partial task training simulator with no technical errors.
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Completion of a hands-on ultrasound guided simulation training protocol on a partial task training simulator until competence is achieved as measured by the ability to cannulate a simulated vein under ultrasound guidance on first pass in five consecutive attempts and correct insertion of a central venous catheter on a partial task training simulator with no technical errors.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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The failure rate of central venous catheter insertion in the hospital setting on actual patients.
Délai: 21 months (January 2007-September 2008)
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21 months (January 2007-September 2008)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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The number of attempts at venous cannulation, and the rate of technical errors and complication rate of central venous catheter insertion in the hospital setting on actual patients
Délai: 21 months (January 2007-September 2008)
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21 months (January 2007-September 2008)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 0605001388
- 5U18HS016725-02 (Subvention/contrat AHRQ des États-Unis)
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