Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service (KatECHO)

Compare the number of attempts to place a peripheral venous catheter in the group of patients hospitalized in the post-emergency unit and benefiting from echo guidance and therapeutic communication, to the group of patients hospitalized on the post-emergency unit using traditional technique.

Study Overview

• Status: Recruiting
• Conditions: Catheterization, Peripheral; Echography; Hospital Units
• Intervention / Treatment: Device: ultrasound guidance and therapeutic communication

• Study Type: Interventional
• Enrollment (Estimated): 276
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Duhoo; Phone Number: +33476767094; Email: jduhoo@chu-grenoble.fr
• Study Contact Backup: Name: Melanie Arnaud; Phone Number: +33476767838; Email: marnaud3@chu-grenoble.fr

Study Locations

• France
  • La Tronche, France, 38700
    • Recruiting
    • Chu Grenoble Alpes
    • Contact: Julie Duhoo; Phone Number: 0476767094; Email: jduhoo@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hospitalized in the post-emergency unit
• Requiring the placement of a venous catheter in the post-emergency unit
• Affiliation to social security or benefiting from such a scheme
• Informed and written consent signed

Exclusion Criteria:

• Protected person (art. L1121-5 to L1121-8 of the CSP)
• Patient included in another interventional study
• Patient already included for a first catheter placement in the post-emergency unit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: echo guidance; insertion of a peripheral venous catheter with ultrasound guidance and therapeutic communication	Device: ultrasound guidance and therapeutic communication; insertion of a peripheral venous catheter with ultrasound guidance and therapeutic communication
No Intervention: conventional; insertion of a peripheral venous catheter conventionally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful placement of a venous catheter on the first attempt	percentage of successful placement of a venous catheter on the first attempt	within the hour after insertion of peripheral venous catheter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient experience	not validated Satisfaction questionnaire and pain scale. score between 0 and 30 corresponding to high satisfaction	within the hour after insertion of peripheral venous catheter
number of attempts to insert a peripheral venous catheter	Average in each group of the number of attempts	within the hour during insertion of peripheral venous catheter
number of calls for a second nurse in the service	Average in each group of the number of service's interveners for a catheter placement	within the hour during insertion of peripheral venous catheter
number of calls to a nurse anesthetist	Average in each group of the number of external interveners	within the hour during insertion of peripheral venous catheter
location of the final placement site	Proportion of patients in each group according to the location of the final placement site	within the hour during insertion of peripheral venous catheter
the caliber of the catheter placed	Proportion of patients in each group according to the caliber of the catheter placed	within the hour during insertion of peripheral venous catheter
infectious or thromboembolic events	total number of infectious or thromboembolic events at the implantation site during the patient's stay in the post-emergency unit	4 days
duration of catheter placement	Average duration, in minutes, of catheter placement in each group	within the hour during insertion of peripheral venous catheter
functional life of the catheter	functional life of the catheter, by group.	4 days
Satisfaction of nursing staff	not validated Satisfaction questionnaire for nursing staff in the post-emergency unit . score between 0 and 55 corresponding to a high satisfaction	at the end of study inclusion, at 6 month

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Study Chair: Perrine Dumanoir, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 38RC19.419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No