Midline Catheter Versus Long Peripheral Intravenous Catheter in Hospitalized Adult Patients

Vascular Access Devices Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884294
• Other study ID #: 2022-0363
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Eneida R Rabelo da Silva, ScD
• Phone: 55 51 33598084
• Email: esilva[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• patients hospitalized in a clinical ward unit;

• indicated for continuous or intermittent intravenous therapy more than five days;

• identified with difficult intravenous access.

Related Conditions & MeSH terms

• Vascular Access Devices

Intervention

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).

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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