Safe-Infusion Study

December 11, 2024 updated by: Interlinked AB

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
548

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Centro Hospitalar e Universitario de Coimbra
        • Contact:
  • Spain
      • Barcelona, Spain, 08830
        • Completed
        • Parc Sanitari Sant Joan de Deu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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'.
Time Frame: Baseline PIVC data and immediatly after PIVC removal

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency and severity of any adverse events
Time Frame: Through study participation (hospitlized in the ward), an average of 5 days
Through study participation (hospitlized in the ward), an average of 5 days
Healthcare workers opinion of investigational device
Time Frame: Immediately after the intervention
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.
Time Frame: Immediatly after PIVC removal
Immediatly after PIVC removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Interlinked AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Parc Sanitari Sant Joan de Déu
Centro Hospitalar e Universitário de Coimbra, E.P.E.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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