Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Intravenous (IV) line placement time
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 -
Exclusion Criteria
- •Patient who has already been included in the study
- •Patient whose inclusion in the study would lead to a delay in treatment
- •Adult patient protected by law
- •Pregnant woman
- •Patient not benefiting from French Social Security system -
Arms & Interventions
Ultra-portable ultrasound
Intervention: Ultra-portable ultrasound (Device)
Standard ultrasound
Comparator
Intervention: Standard ultrasound (Device)
Outcomes
Primary Outcomes
Intravenous (IV) line placement time
Time Frame: Day 0
Time in minutes between tourniquet placement and dressing application after placement.
Secondary Outcomes
- Overall success rate after 3 punctures(Day 0)
- Patient satisfaction with IV line placement(Day 0)
- Date of IV line placement and removal(Day 7)
- Placement of the IV line successfully obtained from the first puncture(12 months (estimated))
- Immediate complications related to intravenous access(Day 0)
- Nurse satisfaction with IV line placement(Day 0)
- Number of skin perforations(Day 0)
- Use an alternative solution (central catheter)(Day 0)
- Delayed complications related to intravenous access(Day 7)