- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07584590
A Brief Intervention by Nurses to Reduce the Prescribing of Occluded Peripheral Venous Catheters in the Emergency Department (PERFEKTO)
Peripheral venous catheters are frequently inserted in hospitals, with approximately 25 million placed annually in France (HAS data, 2005). The occluded peripheral venous catheter with extension tubing has become the standard in some emergency departments, offering advantages such as patient mobility, the ability to perform repeated blood draws, and the administration of intravenous medications. A 2018 meta-analysis revealed that one in three devices was unnecessary. The placement of a occluded peripheral venous is associated with a more painful insertion, higher cost, and an increased risk of infection and thromboembolism, and blood samples obtained via the occluded peripheral venous catheter are more often hemolyzed than those obtained by direct venipuncture.
Communication between physicians and nurses is essential to ensure optimal patient care. A brief intervention by the nurse when a physician prescribes a occluded peripheral venous catheter can help clarify the appropriateness of this prescription, which could lead to reduced pain for the patient, time savings for healthcare providers, and material cost savings for the hospital.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jessica BORTZMEYER, nurse
- Número de teléfono: +33 02.32.88.89.90
- Correo electrónico: jessica.bortzmeyer@chu-rouen.fr
Copia de seguridad de contactos de estudio
- Nombre: ROUSSEL Mélanie, MD
- Correo electrónico: melanie.roussel@chu-rouen.fr
Ubicaciones de estudio
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Amiens, Francia, 80 000
- CHU Amiens
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Contacto:
- Emilen ARNAUD
- Correo electrónico: Arnaud.emilien@chu-amiens.fr
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Angers, Francia, 49 100
- CHU Angers
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Contacto:
- Vanessa TOULIER
- Correo electrónico: Vanessa.toulier@chu-angers.fr
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Clermont-Ferrand, Francia, 63 000
- Chu Clermont Ferrand
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Contacto:
- Dorian TEISSANDIER
- Correo electrónico: dteissandier@chu-clermontferrand.fr
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Créteil, Francia, 94 010
- APHP Henri Mondor
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Contacto:
- Christian Kassasseya
- Correo electrónico: Christian.kassasseya@aphp.fr
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Dieppe, Francia, 76 202
- Ch Dieppe
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Contacto:
- Xavier LAKERMANCE
- Correo electrónico: xlakermance@ch-dieppe.fr
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Eaubonne, Francia, 95 600
- APHP CH Simone Veil
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Contacto:
- Diarra SYLLAH
- Correo electrónico: Diarrah.sylla@ch-simoneveil.fr
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Lyon, Francia, 69 495
- HCL Lyon Sud
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Contacto:
- marion Douplat
- Correo electrónico: Marion.douplat@chu-lyon.fr
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Marseille, Francia, 13013
- HIA Laveran Marseille
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Contacto:
- Nicolas CAZES
- Correo electrónico: Nicolas.cazes@intradef.gouv.fr
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Nancy, Francia, 54 000
- Chru Nancy
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Contacto:
- Tahar CHOUIHED
- Correo electrónico: t.choulhed@chru-nancy.fr
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Nantes, Francia, 44 093
- CHU Nantes
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Contacto:
- François JAVAUDIN
- Correo electrónico: Francoi.javaudin@chu-nantes.fr
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Paris, Francia, 75 010
- APHP Lariboisière
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Contacto:
- Anthony CHAUVIN
- Correo electrónico: Anthony.chauvin@aphp.fr
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Paris, Francia, 75 013
- AP HP Pitié Salpétrière
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Contacto:
- Amélie VROMANT
- Correo electrónico: amelie.vromant@aphp.fr
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Paris, Francia, 75 018
- APHP Bichat
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Contacto:
- Donia BOUZID
- Correo electrónico: Donia.bouzid@aphp.fr
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Paris, Francia, 76 012
- APHP St Antoine
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Contacto:
- Florent NOEL
- Correo electrónico: Florent.noel@aphp.fr
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Rouen, Francia, 76 031
- CHU de ROUEN
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Contacto:
- Jessica BORTZMEYER
- Correo electrónico: jessica.bortzmeyer@chu-rouen.fr
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Toulouse, Francia, 31 300
- CHU Toulouse
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Contacto:
- Thomas PARDON
- Correo electrónico: Pardon.t@toulouse.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients assigned a triage score of 3A, 3B, or 4 according to the French triage scale, or 3 or 4 according to the CIMU triage scale, by the triage nurse
- Patients with a blood draw order involving the placement of an occluded catheter
- Age 18 years or older
- Patients who have read and understood the information sheet
- Patients who have given their verbal consent to participate in the study
- Patients enrolled in a social security program
Exclusion Criteria:
- Patients admitted to the emergency department with a pre-existing intravenous line
- Patients treated by the Mobile Emergency and Resuscitation Unit outside the hospital
- Patients with a blocked catheter who did not undergo an initial blood draw
- Patient with known neurocognitive disorders incompatible with informed consent
- Pregnant or breastfeeding woman
- Patient under legal guardianship (guardianship or conservatorship) or patient deprived of liberty
- Patient refusing to participate in the study
- Patient participating in another interventional research study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Questions for the prescriber
Once the nurse has received the doctor's order for a blood draw with a KTO, she will ask the prescribing physician: Is the KTO being prescribed for: the administration of medication?
The injection of a contrast agent?
A second blood draw?
For each question, there are three possible answers: Yes? No? Maybe?
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Once the nurse has received the doctor's order for a blood draw with a KTO, she will ask the prescribing physician: Is the KTO being prescribed for: the administration of medication?
The injection of a contrast agent?
A second blood draw?
For each question, there are three possible answers: Yes? No? Maybe?
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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the proportion of obturator catheters placed improperly
Periodo de tiempo: day 1
|
Questions for the prescriber
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day 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation between the physician's final decision and nurse activity
Periodo de tiempo: day 1
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Correlation between the physician's final decision and the performance of a repeat biopsy, the administration of contrast dye, or the administration of intravenous treatment
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day 1
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Use of the numerical pain scale during obturator catheter placement
Periodo de tiempo: at the end of procedure (assessed up to 20 minutes)
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pain during obturator catheter placement
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at the end of procedure (assessed up to 20 minutes)
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Micro-costing analysis
Periodo de tiempo: at the end of procedure (assessed up to 20 minutes)
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Micro-costing analysis of the cost of a standard venous blood draw and a closed-catheter procedure
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at the end of procedure (assessed up to 20 minutes)
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Types of intravenous medications administered
Periodo de tiempo: day 1
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Types of intravenous medications administered and available oral alternatives
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day 1
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Number of orders for obturator catheters
Periodo de tiempo: day 1
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Number of orders for obturator catheters placement during the initial blood draw for each period throughout the entire enrollment period
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day 1
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Déborah LEBEDIEFF, MS, University Hospital, Rouen
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2023/0302/HP
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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