Safe-Infusion Study

NCT ID: NCT06727240

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 548 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2025-03-31

Brief Summary

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.

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.

Conditions

Intravenous Access; Medical Device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: DEVICE

The interventional device is a coupling device intended to prevent mechanical complications during peripheral intravenous infusions. While control will not receive the device.

Control

Standard practise related to PIVC infusions according to hospital norm will be followed. Thereafter the planned IV therapy is initiated until completion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention

The interventional device is a coupling device intended to prevent mechanical complications during peripheral intravenous infusions. While control will not receive the device.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc Sanitari Sant Joan de Déu

OTHER

Sponsor Role: collaborator

Unidade Local de Saúde de Coimbra, EPE

OTHER

Sponsor Role: collaborator

Interlinked AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramon Mir Abellán, PhD

Role: PRINCIPAL_INVESTIGATOR

Parc Sanitari Sant Joan de Déu

António Manuel Marques, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidade Local de Saúde de Coimbra, EPE

Locations

Centro Hospitalar e Universitário de Coimbra

Coimbra, , Portugal

Site Status: RECRUITING

Parc Sanitari Sant Joan de Déu

Barcelona, , Spain

Site Status: COMPLETED

Countries

Portugal; Spain

Central Contacts

Christopher Blacker, Medical Doctor

Role: CONTACT

Phone: +46737301399

Email: christopher.blacker@uu.com

Facility Contacts

PI

Role: primary

Other Identifiers

Interlinked 05-01-11

Identifier Type: -

Identifier Source: org_study_id