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A randomised controlled trial to test the effect of long peripheral intravenous catheter with retractable coilded tip guidewire on first insertion success rate in emergency department – Trial Protocol

A randomised controlled trial to test the effect of long peripheral intravenous catheter with retractable coilded tip guidewire on first insertion success rate in emergency department – Trial Protocol

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000299707
Acronym
LOVE-DIVA
Enrollment
406
Registered
2022-02-16
Start date
2022-06-20
Completion date
2024-03-29
Last updated
2022-05-16

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

Conditions

None listed

Brief summary

The primary aim of this randomised controlled trial (RCT) is to compare the clinical and cost effectiveness of new generation peripheral intravenous catheter (PIVC) products with the standard care PIVCs. You may be eligible to participate in this trial if you are an emergency department patient more than the age of 18 and are requiring a peripheral venous catheter inserted as part of your therapy. All participants enrolled in this trial will be randomly allocated (by chance) to receive one of two PIVC options. This will be either the standard PIVC, or a PIVC with a retractable coiled guidewire. The allocated device will be kept from device insertion until the time of device removal. Participants and families will be asked to rate the satisfaction of the device, and the device will be observed closely to examine side effects, device failures and infections. It is hoped that the findings of this trial will provide information on which PIVC devices are most effective in preventing first insertion failure.

Interventions

Participants in this study are patients who have difficult intravenous access and require peripheral intravenous catheters (PIVC) in emergency departments. Consenting participants will have either AccuCath Ace™ Intravascular Cannula (AC-PIVC) in the intervention group or standard care PIVC in the control group. The PIVCs will be inserted by either the Research Nurse or the treating clinician. Intervention group: AC- PIVC. Long AccuCath™ (BD, Salt lake City, UT, USA) peripheral intravenous cathe

Participants in this study are patients who have difficult intravenous access and require peripheral intravenous catheters (PIVC) in emergency departments. Consenting participants will have either AccuCath Ace™ Intravascular Cannula (AC-PIVC) in the intervention group or standard care PIVC in the control group. The PIVCs will be inserted by either the Research Nurse or the treating clinician. Intervention group: AC- PIVC. Long AccuCath™ (BD, Salt lake City, UT, USA) peripheral intravenous catheter (5.8cm length) has a retractable coiled tip guidewire. The randomly allocated PIVCs will be inserted at the time of PVC insertion in ED until device removal. There will be daily checks of the PIVC site to monitor protocol adherence and assess for any complications.

Sponsors

Griffith University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

• >18 years • Require PIVC as part of treatment • Identified as difficult PIVC insertion by meeting at least one of the criteria: (1) lack of visible or palpable vein; (2) history of DIVA or medical history suggesting DIVA; (3) failed one PIVC insertion attempt • Informed written consent

Exclusion criteria

• Presence of a co-existent, or requiring a central venous access device (CVAD) or midline • Patients with upper arm limitations (e.g. mastectomy, renal patients) • Non-English-speaking patients without an interpreter • Patients requiring urgent care (e.g. triage category one) • Patient receiving end-of-life care • Previous enrolment in the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026