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Safe-Infusion Study

NCT06727240 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 548

Last updated 2024-12-16

No results posted yet for this study

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.

Conditions

  • Intravenous Access
  • Medical Device

Interventions

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.

Sponsors & Collaborators

  • Parc Sanitari Sant Joan de Déu

    collaborator OTHER

  • Unidade Local de Saúde de Coimbra, EPE

    collaborator OTHER

  • Interlinked AB

    lead INDUSTRY

Principal Investigators

  • Ramon Mir Abellán, PhD · Parc Sanitari Sant Joan de Déu

  • António Manuel Marques, PhD · Unidade Local de Saúde de Coimbra, EPE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06727240 on ClinicalTrials.gov