Clinical trial NCT06727240: Safe-Infusion Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intravenous Access
Medical Device
Lead sponsor: Interlinked AB
Sponsor class: INDUSTRY
Collaborators: name: Parc Sanitari Sant Joan de Déu
name: Centro Hospitalar e Universitário de Coimbra, E.P.E.
First posted: 2024-12-10
Enrollment: 548
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The rate of mechanical complications of an IV therapy session using the device compared to using current 'state of the art'.
timeFrame: Baseline PIVC data and immediatly after PIVC removal
Secondary outcomes:
measure: Frequency and severity of any adverse events
timeFrame: Through study participation (hospitlized in the ward), an average of 5 days
measure: Healthcare workers opinion of investigational device
timeFrame: Immediately after the intervention
measure: The economic cost of these disruptions to your facility in terms of man-hours, and resources.
timeFrame: Immediatly after PIVC removal
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra
city: Barcelona
country: Spain
facility: Parc Sanitari Sant Joan de Déu
Study officials:
affiliation: Parc Sanitari Sant Joan de Déu
name: Ramon Mir Abellán, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar e Universitário de Coimbra, E.P.E.
name: António Manuel Marques, PhD
role: PRINCIPAL_INVESTIGATOR
References: