NCT05884294

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

January 2, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

January 27, 2023

Last Update Submit

June 16, 2025

Conditions

Keywords

vascular access devicemidline catheterlong Peripheral Intravenous Catheter

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • First-attempt puncture success

    up to 30 days or end of therapy

Other Outcomes (1)

  • Economic analysis

    30 days or end of therapy.

Study Arms (2)

PowerGlide Pro Midline catheter.

EXPERIMENTAL

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.

Introcan Safety Deep Access long peripheral venous catheter.

NO INTERVENTION

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).

Interventions

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).

PowerGlide Pro Midline catheter.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* patients hospitalized in a clinical ward unit; * indicated for continuous or intermittent intravenous therapy more than five days; * identified with difficult intravenous access.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035 903, Brazil

Location

Related Publications (1)

  • Teixeira TO, Hansel LA, Ceratti RDN, Brum ID, Fernandes AGDS, Saline CG, Junges M, Rabelo-Silva ER. Midline catheter (10 cm) versus long peripheral intravenous catheter (6.4 cm): Randomized clinical trial protocol with economic analysis. PLoS One. 2025 Apr 24;20(4):e0319587. doi: 10.1371/journal.pone.0319587. eCollection 2025.

Study Officials

  • Eneida R Rabelo da Silva, ScD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study will be blind to statistical analysis.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized, parallel, open, controlled, and single-center clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2023

First Posted

June 1, 2023

Study Start

January 2, 2024

Primary Completion

February 27, 2025

Study Completion

March 1, 2025

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations