Midline Catheter Versus Long Peripheral Intravenous Catheter in Hospitalized Adult Patients

Overview

This research seeks to compare two types of vascular access (catheters that are inserted into the vein) for patient treatment during hospitalization. This research will evaluate how long each catheter lasts before presenting problems that may lead to its removal from the vein (the most common are swelling on the site of the catheter, clogging of the catheter, infections, or other less common problems. Each patient will be randomly selected to receive either catheter. In this study, we will also estimate how much each patient will spend if any of the problems mentioned occur.

Full Title of Study: “Midline Catheter Versus Long Peripheral Intravenous Catheter in Hospitalized Adult Patients: Randomized Clinical Trial With Economic Analysis From the Perspective of the Public Health System.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2024

Detailed Description

This randomized, parallel, open, controlled, single-center clinical trial is blind to outcome analysis. The use of midline catheter will be compared, regarding duration of use without complications, to the use of long peripheral intravenous catheter during continuous our intermittent intravenous therapy in adult clinical patients who have been hospitalized for up to 30 days. The intervention group will consist of hospitalized adult clinical patients who were identified with difficult intravenous access (DIVA) and who received medical indication of continuous or intermittent intravenous therapy for more than five and a maximum of 30 days of treatment. These patients will receive PowerGlide ProTM Midline catheter. The control group will consist of patients with the same profile described as the intervention group and will receive the insertion of a long peripheral venous catheter Introcan Safety Deep Access. At the end of the study, an economic analysis will be carried out from the perspective of the public health system if the intervention group shows favorable results.

Interventions

  • Device: PowerGlide Pro Midline catheter.
    • The Intervention Group will be represented by hospitalized adult clinical patients who have been identified with difficult intravenous access. These patients will receive an ultrasound-guided insertion of the PowerGlide ProTM Midline 20G (10 cm).

Arms, Groups and Cohorts

  • Experimental: PowerGlide Pro Midline catheter.
    • The Intervention Group will be represented by hospitalized adult clinical patients who have been identified with difficult intravenous access. These patients will receive an ultrasound-guided insertion of the PowerGlide ProTM Midline 20G (10 cm).
  • No Intervention: Introcan Safety Deep Access long peripheral venous catheter.
    • The control group will be subjected to the same selection criteria as the patients in the intervention group; however, they will receive an ultrasound-guided insertion of a long peripheral venous catheter Introcan Safety Deep Access 20G (6.4 cm).

Clinical Trial Outcome Measures

Primary Measures

  • Lenght of time of vascular access without isolated or combined complications.
    • Time Frame: up to 30 days, end of therapy or withdrawal due to any complication
    • Time in days.

Secondary Measures

  • End of the proposed therapy with the same vascular access;
    • Time Frame: up to 30 days or end of therapy
    • Number of catheters used, the complementary materials used and their quantities, the type of dressing for fixing the catheter

Participating in This Clinical Trial

  • patients hospitalized in a clinical ward unit; – indicated for continuous or intermittent intravenous therapy more than five days; – identified with difficult intravenous access.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Hospital de Clinicas de Porto Alegre
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Eneida R Rabelo da Silva, ScD, Principal Investigator, Hospital de Clínicas de Porto Alegre
    • Overall Contact(s)
      • Eneida R Rabelo da Silva, ScD, 55 51 33598084, esilva@hcpa.edu.br

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