- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jessica BORTZMEYER, nurse
- Numéro de téléphone: +33 02.32.88.89.90
- E-mail: jessica.bortzmeyer@chu-rouen.fr
Sauvegarde des contacts de l'étude
- Nom: ROUSSEL Mélanie, MD
- E-mail: melanie.roussel@chu-rouen.fr
Lieux d'étude
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Amiens, France, 80 000
- CHU Amiens
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Contact:
- Emilen ARNAUD
- E-mail: Arnaud.emilien@chu-amiens.fr
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Angers, France, 49 100
- CHU Angers
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Contact:
- Vanessa TOULIER
- E-mail: Vanessa.toulier@chu-angers.fr
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Clermont-Ferrand, France, 63 000
- Chu Clermont Ferrand
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Contact:
- Dorian TEISSANDIER
- E-mail: dteissandier@chu-clermontferrand.fr
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Créteil, France, 94 010
- APHP Henri Mondor
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Contact:
- Christian Kassasseya
- E-mail: Christian.kassasseya@aphp.fr
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Dieppe, France, 76 202
- Ch Dieppe
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Contact:
- Xavier LAKERMANCE
- E-mail: xlakermance@ch-dieppe.fr
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Eaubonne, France, 95 600
- APHP CH Simone Veil
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Contact:
- Diarra SYLLAH
- E-mail: Diarrah.sylla@ch-simoneveil.fr
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Lyon, France, 69 495
- HCL Lyon Sud
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Contact:
- Marion DOUPLAT
- E-mail: marion.douplat@chu-lyon.fr
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Marseille, France, 13013
- HIA Laveran Marseille
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Contact:
- Nicolas CAZES
- E-mail: Nicolas.cazes@intradef.gouv.fr
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Nancy, France, 54 000
- CHRU NANCY
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Contact:
- Tahar CHOUIHED
- E-mail: t.choulhed@chru-nancy.fr
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Nantes, France, 44 093
- CHU Nantes
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Contact:
- François JAVAUDIN
- E-mail: Francoi.javaudin@chu-nantes.fr
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Paris, France, 75 010
- APHP Lariboisière
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Contact:
- Anthony CHAUVIN
- E-mail: Anthony.chauvin@aphp.fr
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Paris, France, 75 013
- AP HP Pitié Salpétrière
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Contact:
- Amélie VROMANT
- E-mail: amelie.vromant@aphp.fr
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Paris, France, 75 018
- APHP Bichat
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Contact:
- Donia BOUZID
- E-mail: Donia.bouzid@aphp.fr
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Paris, France, 76 012
- APHP St Antoine
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Contact:
- Florent NOEL
- E-mail: Florent.noel@aphp.fr
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Rouen, France, 76 031
- CHU de Rouen
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Contact:
- Jessica BORTZMEYER
- E-mail: jessica.bortzmeyer@chu-rouen.fr
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Toulouse, France, 31 300
- CHU Toulouse
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Contact:
- Thomas PARDON
- E-mail: Pardon.t@toulouse.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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the proportion of obturator catheters placed improperly
Délai: day 1
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Questions for the prescriber
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day 1
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Correlation between the physician's final decision and nurse activity
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Déborah LEBEDIEFF, MS, University Hospital, Rouen
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Autres numéros d'identification d'étude
- 2023/0302/HP
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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