Comparing neutral and negative pressure needleless connectors – A pilot randomised controlled trial

Dr Nicole Marsh1,2,3,4,5, Ms Emily Larsen1,2,3, Ms Catherine O’Brien1, Ms Hannah  Peach1, Professor Samantha  Keogh1,2,5, Dr Karen Davies1,6, Mr Gabor Mihala2,7, Ms Barbara Hewer1, Dr Catriona  Booker1, Professor Alexandra McCarthy4,8, Dr Julie Flynn9, Professor Claire Rickard2,4,6

1Royal Brisbane And Women’s Hospital, Herston, Australia
2School of Nursing and Midwifery; Alliance for Vascular Access, Teaching and Research, Griffith University, Nathan, Australia
3Patient-Centred Health Services, Menzies Health, Brisbane, Australia
4School of Nursing, Midwifery and Social Work, University of Queensland, St Lucia, Australia
5School of Nursing, Queensland University of Technology, Brisbane, Australia
6Herston Infectious Diseases Institute, Metro North Health , Brisbane , Australia
7School of Medicine and Dentistry, Griffith University, Nathan, Australia
8Mater Research Institute, University of Queensland, Brisbane, Australia
9University of Southern Queensland, Brisbane, Australia

Introduction: Needleless connectors (NCs) link peripheral intravenous catheters (PIVCs) with syringes and administration sets. There are multiple types of NCs with different structural and fluid displacement properties.  Negative pressure NCs create a negative displacement, allowing a small amount of blood to move (reflux) into catheter on disconnection, and neutral pressure NCs have been designed to limit blood reflux. It is unclear the impact fluid displacement has on catheter occlusion and infection as this is yet to be examined in a randomised control trial (RCT). The aim of this trial was to test the feasibility of a study protocol comparing the efficacy of neutral- and negative-pressure NCs.

Methods: A single-centre, parallel group, pilot RCT comparing neutral- (intervention) and negative-pressure (control) NCs in an Australian adult hospital. The primary feasibility outcomes were measured against predetermined criteria (e.g., eligibility, attrition). The primary efficacy outcome was all-cause PIVC failure analysed as time to event data.

Results: In total, 201 (100 control; 101 intervention) participants were enrolled between March and September 2020. All feasibility criteria were met except eligibility, which was lower (78%) than the 80% criterion. All-cause PIVC failure was significantly higher in the intervention group (39%) compared to control (19%). This equated to an adjusted hazard ratio of 1.92 (95% confidence interval 1.10–3.37). There were no catheter-related bloodstream infections in either group.

Conclusion: Preliminary findings suggest neutral NC are associated with an increased risk of PIVC failure. With minor modifications to participant eligibility screening, a larger multicentre RCT is feasible.


Biography: Professor  Nicole Marsh’s is the Nursing and Midwifery Director for Research at the Royal Brisbane and Women’s Hospital. Her program of research is focused on improving patient outcomes and decreasing complications associated with vascular access across the acute clinical care and community setting. Her PhD addressed risk factors for peripheral intravenous catheter failure in the adult population. In addition, she has been a Clinical Trial Co-ordinator for more than 30 single and multi-centre clinical trials.

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