Safe-Infusion Study

A Non-Inferiority Randomized Clinical Trial Investigating Efficacy and Safety of an Innovative Medical Device in the Reduction of Mechanical Complications of Peripheral Intravenous Catheters

Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or dislodgement. These complications can collectively be named mechanical complications. This study aims to assess a new device's effectiveness in reducing mechanical complications associated with PIVCs through a non-inferiority randomized trial at two sites. A total of 548 patients will be recruited, with primary outcomes focused on complication rates and secondary outcomes examining adverse events, healthcare feedback, and economic impacts.

Study Overview

• Status: Recruiting
• Conditions: Medical Device; Intravenous Access
• Intervention / Treatment: Device: Intervention

Detailed Description

It is estimated that around 1.5 billion PIVC are sold yearly throughout the globe, and placing them is one of the most common invasive procedures in hospitalised patients, with up to 90% receiving one, yet there is a failure rate of up to 69%.1-5 Some of the most common causes of failure are considered to be phlebitis, subcutaneous infiltration, occlusion and dislodgement. These failure rates vary widely throughout the globe, where published data suggests rates of 8-44% for phlebitis, 5-21% for infiltration, 7.6-16% for occlusion and 5-10% for dislodgement.4,6-12 Phlebitis, commonly defined as an inflammatory process in the wall of a vein, resulting in a blood clot formation; while infiltration is defined as the inadvertent leakage of a solution into the surrounding tissue; occlusion is defined as catheter failure due to blockage, and dislodgement the accidental/ in adverted removal of the PIVC before intended.13 Previous studies have suggested that mechanical irritation could be an important factor resulting in PIVC failure.14-16 In the case of phlebitis, mechanical movements against the endothelial wall could initiate a cascade of prothrombotic events resulting in the formation of a blood clot, something that has been demonstrated in a simulated environment.14,17,18 Furthermore micromechanical movements of the PIVC could eventually lead the PIVC to migrate from within the vessel wall to be unintentionally placed outside the vessel, yet, still in the surrounding tissue causing infiltration. Occlusion is the sudden block of the PIVC, where flushing or aspirating from the PIVC is not possible. Dislodgement of a PIVC is the act of mechanical movement of the PIVC from the intravascular space to the surrounding environment outside of the body.

Therefore, there is a need to investigate potential new methods for prevention of these mechanical complications, and one method could be in the reduction of mechanical forces acting on the vessels. The aim of this study is to investigate the safety and effectiveness of a new medical device in reducing the number of mechanical complications during IV therapy.

To answer this aim, a non-inferiority randomized clinical trial will be executed at two sites, where patients having a vascular access will be examined in a systematic fashion. Inclusion criteria are: having VAD, >18 years of age, speak local language, absence of signs of phlebitis or infiltration, and a signed consent form. Exclusion criteria are: VAD for sampling only, pregnancy, unable to obtain informed consent, patients under palliative care and VAD for bolus infusion only.

A total of 548 patients will be recruited to this study, and it is estimated to take 5 months to complete. The primary outcomes/endpoints are to investigate the rate of mechanical complications in the form of phlebitis, infiltration, occlusion and dislodgement. While secondary outcomes/endpoints will be identifying the frequency and severity of any adverse events, healthcare opinions on the device and the economic burden of the mechanical complications. No follow up is planned in this trial.

• Study Type: Interventional
• Enrollment (Estimated): 548
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Blacker, Medical Doctor; Phone Number: +46737301399; Email: christopher.blacker@uu.com

Study Locations

• Portugal
  • Coimbra, Portugal, 3000-075
    • Recruiting
    • Centro Hospitalar E Universitário De Coimbra
    • Contact: PI; Phone Number: +351 239 400 400; Email: amarques@chuc.min-saude.pt
• Spain
  • Barcelona, Spain, 08830
    • Completed
    • Parc Sanitari Sant Joan de Deu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient has or will get a vascular access device (VAD) expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥2h and intermitted as an infusion lasting 15min to <2h.
• ≥18 years of age
• Speak and understand local language
• VADs already in place when the patient is admitted to the ward should not present with phlebitis or infiltration or occlusion
• Participants have signed the informed consent or have a legal authorized representative (LAR) who has provided this consent

Exclusion Criteria:

• The VAD is expected to be used for sampling only
• Pregnancy
• Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
• Patients under palliative care
• Bolus IV infusion, defined as an infusion time of <15 min

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard practise related to PIVC infusions according to hospital norm will be followed. Thereafter the planned IV therapy is initiated until completion.
Experimental: ReLink®; One or more investigational devices will be added to the infusion line. Standard practise procedure related to PIVC infusions according to hospital norm will be followed. Thereafter the planned IV therapy is initiated until completion.	Device: Intervention; The interventional device is a coupling device intended to prevent mechanical complications during peripheral intravenous infusions. While control will not receive the device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of mechanical complications of an IV therapy session using the device compared to using current 'state of the art'.	Mechanical complications are defied as following: Phlebitis -inflammation of a vein based on clinical diagnosis; Infiltration - the process of accidental leakage of fluids out of the veins into peripheral tissue; Occlusion - blocked PIVC, where flushing or aspirating from the PIVC is not possible; Dislodgment - the process of accidental/ unintentional complete removal of the PIVC before scheduled removal	Baseline PIVC data and immediatly after PIVC removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and severity of any adverse events		Through study participation (hospitlized in the ward), an average of 5 days
Healthcare workers opinion of investigational device	A questionnaire has been developed asking baseline data from healthcare worker. The questionnaire contains questions about 1) opinion about using the device again, 2) recommendation of the device, and 3) usage of the device for a relative. Each question is ranked from 0 to 5.	Immediately after the intervention
The economic cost of these disruptions to your facility in terms of man-hours, and resources.		Immediatly after PIVC removal

Collaborators and Investigators

• Sponsor: Interlinked AB
• Collaborators: Parc Sanitari Sant Joan de Déu; Centro Hospitalar e Universitário de Coimbra, E.P.E.
• Investigators: Principal Investigator: Ramon Mir Abellán, PhD, Parc Sanitari Sant Joan de Deu; Principal Investigator: António Manuel Marques, PhD, Centro Hospitalar e Universitário de Coimbra, E.P.E.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Interlinked 05-01-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All research results will be reported at a de-identified level, and any statistical correlations linked to personal data in terms of gender and/or age will be reported at an aggregated level.
• IPD Sharing Time Frame: Within 1 year of study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No