Clinical trial NCT05884294: Midline Catheter Versus Long Peripheral Intravenous Catheter in Hospitalized Adult Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Devices
Keywords: vascular access device
midline catheter
long Peripheral Intravenous Catheter
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, parallel, open, controlled, and single-center clinical trial.
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: Lenght of time of vascular access without isolated or combined complications.
timeFrame: up to 30 days, end of therapy or withdrawal due to any complication
Secondary outcomes:
measure: First-attempt puncture success
timeFrame: up to 30 days or end of therapy
Other outcomes:
measure: Economic analysis
timeFrame: 30 days or end of therapy.
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Eneida R Rabelo da Silva, ScD
role: PRINCIPAL_INVESTIGATOR
References: