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

NCT06296264 | Recruiting

• 1 other identifier: ULTRACATHLON
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IV Line Placement With Ultrasound

Keywords

IV line; Ultra-portable ultrasound; Standard ultrasound

Outcome Measures

Primary Outcomes (1)

• Intravenous (IV) line placement time

  Time in minutes between tourniquet placement and dressing application after placement.

  Day 0

Secondary Outcomes (9)

• Placement of the IV line successfully obtained from the first puncture

  12 months (estimated)

• Number of skin perforations

  Day 0

• Overall success rate after 3 punctures

  Day 0

• Use an alternative solution (central catheter)

  Day 0

• Patient satisfaction with IV line placement

  Day 0

Study Arms (2)

Standard ultrasound

OTHER

Comparator

Device: Standard ultrasound

Ultra-portable ultrasound

EXPERIMENTAL

Device: Ultra-portable ultrasound

Interventions

Standard ultrasound DEVICE

Placement of IV line using standard ultrasound.

Standard ultrasound

Ultra-portable ultrasound DEVICE

Placement of IV line using ultra-portable ultrasound.

Ultra-portable ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient who has already been included in the study
• Adult patient protected by law
• Pregnant woman
• Patient not benefiting from French Social Security system -

Sponsors & Collaborators

• Centre Hospitalier Saint Joseph Saint Luc de Lyon: lead

Study Sites (1)

Saint Joseph Saint Luc Hospital

Lyon, Auvergne-Rhône-Alpes, 69007, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 6, 2024
• Study Start: August 27, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

FR (1)