Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture

The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain.

The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room.

Study Overview

• Status: Not yet recruiting
• Conditions: IV Line Placement With Ultrasound
• Intervention / Treatment: Device: Standard ultrasound; Device: Ultra-portable ultrasound

Detailed Description

The main objective is to test the hypothesis that intravenous puncture guided by an ultraportable ultrasound machine is faster than puncture guided by a conventional ultrasound machine.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhone-alpes
    • Lyon, Rhone-alpes, France, 69007
      • Saint Joseph Saint Luc Hospital
      • Contact: Emmanuel VIVIER, MD; Phone Number: 0033478618209; Email: evivier@saintjosephsaintluc.fr
      • Contact: Fanny DOROSZEWSKI, Mrs; Phone Number: 0033478618398; Email: fdoroszewski@saintjosephsaintluc.fr
      • Principal Investigator: Emmanuel VIVIER, MD
      • Sub-Investigator: Raphaël STREIFF, MD
      • Sub-Investigator: Guillaume MARCOTTE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient aged at least 18 years old
2. Patient with an A-DIVA (Adult Difficult Intravenous Access) score > 1
3. Supported by a nurse trained in all the techniques used in the protocol
4. Patient having given free, informed and oral consent -

Exclusion Criteria:

1. Patient who has already been included in the study
2. Patient whose inclusion in the study would lead to a delay in treatment
3. Adult patient protected by law
4. Pregnant woman
5. Patient not benefiting from French Social Security system -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard ultrasound; Comparator	Device: Standard ultrasound; Placement of IV line using standard ultrasound.
Experimental: Ultra-portable ultrasound	Device: Ultra-portable ultrasound; Placement of IV line using ultra-portable ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intravenous (IV) line placement time	Time in minutes between tourniquet placement and dressing application after placement.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placement of the IV line successfully obtained from the first puncture	Percentage of cases where the placement of the IV line was obtained from the first puncture	12 months (estimated)
Number of skin perforations	Number of skin perforations required to establish the IV line	Day 0
Overall success rate after 3 punctures	Overall success rate after 3 punctures	Day 0
Use an alternative solution (central catheter)	Need to use an alternative solution (central catheter)	Day 0
Patient satisfaction with IV line placement	Patient satisfaction with intravenous line placement (assessed by Likert scale)	Day 0
Nurse satisfaction with IV line placement	Nurse satisfaction with intravenous line placement (assessed by Likert scale)	Day 0
Immediate complications related to intravenous access	Number of immediate complications related to intravenous access, including arterial puncture and/or hematoma formation	Day 0
Delayed complications related to intravenous access	Number of delayed complications related to intravenous access, including extravasation and/or the occurrence of infectious thrombophlebitis	Day 7
Date of IV line placement and removal	Delays between IV line placement and removal	Day 7

Collaborators and Investigators

• Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: IV line; Ultra-portable ultrasound; Standard ultrasound
• Other Study ID Numbers: ULTRACATHLON

Drug and device information, study documents

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