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 volunteersQualifiers
Visible with distention and easily palpable
Visible and easily palpable
Not visible and easily palpable
Visible and poorly palpable
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
B. Braun 6.35cm 20 gauge ultralong intravenous catheter
DeviceB Braun Medical Inc, 6.35cm 20 gauge ultralong intravenous catheter
BD 5.71 cm 20 gauge Accucath
DeviceBard Access Systems, Inc, BD 5.71 cm 20 gauge ultralong intravenous catheter with guide wire
Treatment groups
Trial outcomes
Primary outcomes
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 to insertion
Time to insertion(measured in minutes). Time to insertion is defined as needlestick to dressing application.
First-stick success rate
Number of patients with only one puncture of skin to achieve venous access
Secondary outcomes
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
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.
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).
Sponsors and contacts
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