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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06296264
Enrollment
250
Registered
2024-03-06
Start date
2024-08-27
Completion date
2025-09-30
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IV Line Placement With Ultrasound

Keywords

IV line, Ultra-portable ultrasound, Standard ultrasound

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.

Interventions

Placement of IV line using standard ultrasound.

DEVICEUltra-portable ultrasound

Placement of IV line using ultra-portable ultrasound.

Sponsors

Centre Hospitalier Saint Joseph Saint Luc de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frameDescription
Intravenous (IV) line placement timeDay 0Time in minutes between tourniquet placement and dressing application after placement.

Secondary

MeasureTime frameDescription
Number of skin perforationsDay 0Number of skin perforations required to establish the IV line
Overall success rate after 3 puncturesDay 0Overall success rate after 3 punctures
Use an alternative solution (central catheter)Day 0Need to use an alternative solution (central catheter)
Patient satisfaction with IV line placementDay 0Patient satisfaction with intravenous line placement (assessed by Likert scale)
Placement of the IV line successfully obtained from the first puncture12 months (estimated)Percentage of cases where the placement of the IV line was obtained from the first puncture
Immediate complications related to intravenous accessDay 0Number of immediate complications related to intravenous access, including arterial puncture and/or hematoma formation
Delayed complications related to intravenous accessDay 7Number of delayed complications related to intravenous access, including extravasation and/or the occurrence of infectious thrombophlebitis
Date of IV line placement and removalDay 7Delays between IV line placement and removal
Nurse satisfaction with IV line placementDay 0Nurse satisfaction with intravenous line placement (assessed by Likert scale)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026