Midline Catheter Versus Long Peripheral Intravenous Catheter in Hospitalized Adult Patients

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Access Devices
• Intervention / Treatment: Device: PowerGlide Pro Midline catheter.

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.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eneida R Rabelo da Silva, ScD; Phone Number: 8084 55 51 33598084; Email: esilva@hcpa.edu.br
• Study Contact Backup: Name: Tiago Teixeira, MSc; Phone Number: 7878 55 51 33597878; Email: tteixeira@hcpa.edu.br

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035 903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: Eneida Rejane R da Silva, ScD; Phone Number: 55 51 33598084; Email: eneidarabelo@gmail.com
      • Principal Investigator: Eneida Rejane R da Silva, ScD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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).
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Eneida R Rabelo da Silva, ScD, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: vascular access device; midline catheter; long Peripheral Intravenous Catheter
• Other Study ID Numbers: 2022-0363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No