Controlling peripheral intravenous catheter failure by needleless connector design: A pilot randomised...

Area of Science:

• Medical Devices
• Infection Control
• Clinical Trials

Background:

• Needleless connectors (NCs) are crucial for intravenous therapy but can contribute to catheter failure.
• Different NC designs, categorized by pressure mechanism (positive, negative, neutral), exist with varying clinical implications.
• Limited comparative data exists on the efficacy of different NC pressure mechanisms in preventing catheter failure.

Purpose of the Study:

• To assess the feasibility of a randomized controlled trial protocol comparing neutral- and negative-pressure needleless connectors.
• To evaluate the efficacy of neutral- versus negative-pressure NCs in preventing peripheral intravenous catheter failure.

Main Methods:

• A single-center, parallel-group, pilot randomized controlled trial was conducted.
• Adult patients in an Australian hospital were randomized to either neutral- (intervention) or negative-pressure (control) NCs.
• Primary feasibility outcomes included eligibility and attrition rates; the primary efficacy outcome was all-cause peripheral intravenous catheter failure.

Main Results:

• 201 participants were enrolled; eligibility rate was 78%, below the 90% criterion, indicating a need for protocol adjustment.
• All-cause peripheral intravenous catheter failure was significantly higher in the neutral NC group (39%) compared to the negative-pressure NC group (19%).

Conclusions:

• The randomized controlled trial protocol is feasible for larger multicenter studies with minor modifications to participant screening.
• Neutral needleless connectors are associated with an increased risk of peripheral intravenous catheter failure compared to negative-pressure designs.