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

Not Applicable

Recruiting

• Conditions: IV Line Placement With Ultrasound
• Interventions: Device: Standard ultrasound; Device: Ultra-portable ultrasound

• Registration Number: NCT06296264
• Lead Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

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.

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 Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-06
• Study Start: 2024-08-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-04
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard ultrasound	Standard ultrasound	Comparator
Ultra-portable ultrasound	Ultra-portable ultrasound	-

Primary Outcome Measures

Name	Time	Method
Intravenous (IV) line placement time	Day 0	Time in minutes between tourniquet placement and dressing application after placement.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Saint Joseph Saint Luc Hospital; 🇫🇷 Lyon, Rhone-alpes, France