Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter Survival

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorewell Health East

About this trial

This is a prospective, parallel, non-blinded, two-arm randomized controlled trial of intravenous catheter failure evaluating the impact of a built-in guide wire. The objective of this study is to demonstrate that the control ultralong intravenous catheter (IV) without the guide wire is non-inferior to the experimental catheter with the guide wire. After obtaining consent, eligible patients will be randomly allocated to control Arm 1 (ultralong intravenous catheter) or experimental Arm 2 (ultralong intravenous catheter with guide wire) in a ratio of 1:1 via a computer-generated randomization schedule. The participants will be followed to collect data until the catheter is removed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Visible with distention and easily palpable

Visible and easily palpable

Not visible and easily palpable

Visible and poorly palpable

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • B. Braun 6.35cm 20 gauge ultralong intravenous catheter

    Device

    B Braun Medical Inc, 6.35cm 20 gauge ultralong intravenous catheter

  • BD 5.71 cm 20 gauge Accucath

    Device

    Bard Access Systems, Inc, BD 5.71 cm 20 gauge ultralong intravenous catheter with guide wire

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Arm 1 (6.35cm 20 gauge ultralong intravenous catheter)Active comparator 1 intervention
Group B: Arm 2 (5.71 cm 20 gauge Accucath)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survival of the BBraun 6.35 centimeter 20 gauge ultralong intravenous catheter compared to the BD 5.71 cm 20 gauge ultralong intravenous catheter with guide wire

Survival of catheter will be measured in hours from time of insertion to time of removal or failure. Functionality is defined as being able to aspirate blood and/or flush without resistance with 3-5 milliliters of saline. If unable, the catheter is considered to have failed.

Time frame
up to 15 days or the duration of the IV catheter
2

Time to insertion

Time to insertion(measured in minutes). Time to insertion is defined as needlestick to dressing application.

Time frame
First day of hospitalization
3

First-stick success rate

Number of patients with only one puncture of skin to achieve venous access

Time frame
First day of hospitalization

Secondary outcomes

1

Cost for all vascular needs during hospitalization

Cost per patient for vascular access during hospitalization, comprising of 1) direct costs of IV insertion based on labor and material costs per insertion attempt and estimated similar costs of rescue devices if needed and 2) cost of treatment based on estimated cost per hour

Time frame
up to 15 days or the duration of the IV catheter
2

Catheter Associated Thrombosis

Number of participants with all symptomatic catheter related upper extremity venous thrombosis inclusive of superficial thrombophlebitis, deep venous thrombosis, and pulmonary embolism will be confirmed by upper extremity doppler evaluation, computed tomography, and/or ventilation perfusion testing.

Time frame
up to 30 days post discharge
3

Catheter Associated bloodstream infection

Number of participants with catheter-associated bloodstream infection. Cases of infection will be identified using confirmed catheter-related blood stream infection data collected by the surveillance team within the epidemiology department as per the Centers for Disease Control definition of laboratory-confirmed blood-stream infection (CLABSI).

Time frame
up to 30 days post discharge

Other outcomes

Sponsors and contacts

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