- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jessica BORTZMEYER, nurse
- Telefonnummer: +33 02.32.88.89.90
- E-post: jessica.bortzmeyer@chu-rouen.fr
Studer Kontakt Backup
- Navn: ROUSSEL Mélanie, MD
- E-post: melanie.roussel@chu-rouen.fr
Studiesteder
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Amiens, Frankrike, 80 000
- CHU Amiens
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Ta kontakt med:
- Emilen ARNAUD
- E-post: Arnaud.emilien@chu-amiens.fr
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Angers, Frankrike, 49 100
- CHU Angers
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Ta kontakt med:
- Vanessa TOULIER
- E-post: Vanessa.toulier@chu-angers.fr
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Clermont-Ferrand, Frankrike, 63 000
- CHU Clermont Ferrand
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Ta kontakt med:
- Dorian TEISSANDIER
- E-post: dteissandier@chu-clermontferrand.fr
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Créteil, Frankrike, 94 010
- APHP Henri Mondor
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Ta kontakt med:
- Christian Kassasseya
- E-post: Christian.kassasseya@aphp.fr
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Dieppe, Frankrike, 76 202
- Ch Dieppe
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Ta kontakt med:
- Xavier LAKERMANCE
- E-post: xlakermance@ch-dieppe.fr
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Eaubonne, Frankrike, 95 600
- APHP CH Simone Veil
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Ta kontakt med:
- Diarra SYLLAH
- E-post: Diarrah.sylla@ch-simoneveil.fr
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Lyon, Frankrike, 69 495
- HCL Lyon Sud
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Ta kontakt med:
- Marion DOUPLAT
- E-post: marion.douplat@chu-lyon.fr
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Marseille, Frankrike, 13013
- HIA Laveran Marseille
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Ta kontakt med:
- Nicolas CAZES
- E-post: Nicolas.cazes@intradef.gouv.fr
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Nancy, Frankrike, 54 000
- CHRU Nancy
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Ta kontakt med:
- Tahar CHOUIHED
- E-post: t.choulhed@chru-nancy.fr
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Nantes, Frankrike, 44 093
- CHU Nantes
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Ta kontakt med:
- François JAVAUDIN
- E-post: Francoi.javaudin@chu-nantes.fr
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Paris, Frankrike, 75 010
- APHP Lariboisière
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Ta kontakt med:
- Anthony CHAUVIN
- E-post: Anthony.chauvin@aphp.fr
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Paris, Frankrike, 75 013
- AP HP Pitié Salpétrière
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Ta kontakt med:
- Amélie VROMANT
- E-post: amelie.vromant@aphp.fr
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Paris, Frankrike, 75 018
- APHP Bichat
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Ta kontakt med:
- Donia BOUZID
- E-post: Donia.bouzid@aphp.fr
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Paris, Frankrike, 76 012
- APHP St Antoine
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Ta kontakt med:
- Florent NOEL
- E-post: Florent.noel@aphp.fr
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Rouen, Frankrike, 76 031
- CHU de ROUEN
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Ta kontakt med:
- Jessica BORTZMEYER
- E-post: jessica.bortzmeyer@chu-rouen.fr
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Toulouse, Frankrike, 31 300
- Chu Toulouse
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Ta kontakt med:
- Thomas PARDON
- E-post: Pardon.t@toulouse.fr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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the proportion of obturator catheters placed improperly
Tidsramme: day 1
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Questions for the prescriber
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day 1
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Correlation between the physician's final decision and nurse activity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Déborah LEBEDIEFF, MS, University Hospital, Rouen
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2023/0302/HP
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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