- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica BORTZMEYER, nurse
- Phone Number: +33 02.32.88.89.90
- Email: jessica.bortzmeyer@chu-rouen.fr
Study Contact Backup
- Name: ROUSSEL Mélanie, MD
- Email: melanie.roussel@chu-rouen.fr
Study Locations
-
-
-
Amiens, France, 80 000
- CHU Amiens
-
Contact:
- Emilen ARNAUD
- Email: Arnaud.emilien@chu-amiens.fr
-
Angers, France, 49 100
- CHU Angers
-
Contact:
- Vanessa TOULIER
- Email: Vanessa.toulier@chu-angers.fr
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Clermont-Ferrand, France, 63 000
- Chu Clermont Ferrand
-
Contact:
- Dorian TEISSANDIER
- Email: dteissandier@chu-clermontferrand.fr
-
Créteil, France, 94 010
- APHP Henri Mondor
-
Contact:
- Christian Kassasseya
- Email: Christian.kassasseya@aphp.fr
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Dieppe, France, 76 202
- Ch Dieppe
-
Contact:
- Xavier LAKERMANCE
- Email: xlakermance@ch-dieppe.fr
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Eaubonne, France, 95 600
- APHP CH Simone Veil
-
Contact:
- Diarra SYLLAH
- Email: Diarrah.sylla@ch-simoneveil.fr
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Lyon, France, 69 495
- HCL Lyon Sud
-
Contact:
- marion Douplat
- Email: Marion.douplat@chu-lyon.fr
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Marseille, France, 13013
- HIA Laveran Marseille
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Contact:
- Nicolas CAZES
- Email: Nicolas.cazes@intradef.gouv.fr
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Nancy, France, 54 000
- CHRU Nancy
-
Contact:
- Tahar CHOUIHED
- Email: t.choulhed@chru-nancy.fr
-
Nantes, France, 44 093
- CHU Nantes
-
Contact:
- François JAVAUDIN
- Email: Francoi.javaudin@chu-nantes.fr
-
Paris, France, 75 010
- APHP Lariboisière
-
Contact:
- Anthony CHAUVIN
- Email: Anthony.chauvin@aphp.fr
-
Paris, France, 75 013
- AP HP Pitié Salpétrière
-
Contact:
- Amélie VROMANT
- Email: amelie.vromant@aphp.fr
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Paris, France, 75 018
- APHP Bichat
-
Contact:
- Donia BOUZID
- Email: Donia.bouzid@aphp.fr
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Paris, France, 76 012
- APHP St Antoine
-
Contact:
- Florent NOEL
- Email: Florent.noel@aphp.fr
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Rouen, France, 76 031
- CHU de Rouen
-
Contact:
- Jessica BORTZMEYER
- Email: jessica.bortzmeyer@chu-rouen.fr
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Toulouse, France, 31 300
- CHU Toulouse
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Contact:
- Thomas PARDON
- Email: Pardon.t@toulouse.fr
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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?
|
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?
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the proportion of obturator catheters placed improperly
Time Frame: day 1
|
Questions for the prescriber
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between the physician's final decision and nurse activity
Time Frame: day 1
|
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
|
day 1
|
|
Use of the numerical pain scale during obturator catheter placement
Time Frame: at the end of procedure (assessed up to 20 minutes)
|
pain during obturator catheter placement
|
at the end of procedure (assessed up to 20 minutes)
|
|
Micro-costing analysis
Time Frame: at the end of procedure (assessed up to 20 minutes)
|
Micro-costing analysis of the cost of a standard venous blood draw and a closed-catheter procedure
|
at the end of procedure (assessed up to 20 minutes)
|
|
Types of intravenous medications administered
Time Frame: day 1
|
Types of intravenous medications administered and available oral alternatives
|
day 1
|
|
Number of orders for obturator catheters
Time Frame: day 1
|
Number of orders for obturator catheters placement during the initial blood draw for each period throughout the entire enrollment period
|
day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Déborah LEBEDIEFF, MS, University Hospital, Rouen
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023/0302/HP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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