None listed
Conditions
Brief summary
Aims: To determine the feasibility of a larger study in patients with difficult intravenous access to compare short-bevelled peripheral intravenous catheters (SB-PIVCs) with standard PIVCs. Participants: 100 adult patients from medical/surgical and oncology/haematology wards. 3-4 staff PIVC inserters for process evaluation. Methods: Pilot randomised controlled trial. Patients will be randomised to have either a SB-PIVC or standard PIVC inserted to facilitate their clinical care. Patients will be visited daily by research nurses for data collection. The study will end when the PIVC is removed as clinically indicated. Small process evaluation included. Expected outcomes: It will be feasible to conduct a larger trial and first-time insertion success will be higher in the SB-PIVC group than the standard PIVC group.
Interventions
Short bevelled peripheral intravenous catheter (SB-PIVC) (Surflo Zero, 3D-Shin®, Terumo Corporation, Tokyo, Japan)
The intervention will be delivered once per patient. The intervention time period (ie. device dwell time) will be as clinically indicated. PIVCs will be followed for their entire dwell time.
The SB-PIVC will be used at the recruiting hospital and inserted by hospital-credentialled research staff whilst the patient is in hospital and as clinically indicated.
The device will be monit
Short bevelled peripheral intravenous catheter (SB-PIVC) (Surflo Zero, 3D-Shin®, Terumo Corporation, Tokyo, Japan) The intervention will be delivered once per patient. The intervention time period (ie. device dwell time) will be as clinically indicated. PIVCs will be followed for their entire dwell time. The SB-PIVC will be used at the recruiting hospital and inserted by hospital-credentialled research staff whilst the patient is in hospital and as clinically indicated. The device will be monitored daily for the entirety of it's dwell by research staff to assess for protocol adherence and device complications.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient greater than or equal to 16 years 2. PIVC required for greater than or equal to 24 hours 3. Identified as difficult PIVC insertion by meeting at least one of the following a. Lack of visible and/or palpable veins b. Medical history of DIVA or high risk for DIVA (eg. End-stage renal disease and receiving dialysis, IV drug user, sickle cell disease etc) c. Prior failed PIVC insertion attempt
Exclusion criteria
1. Veins deeper than 1 cm from skin surface 2. Unable to provide informed consent 3. Previous study enrolment 4. End-of-life pathway
Outcome results
None listed