Study to Estimate the Point Prevalence of Peripheral Intravenous Catheter-related Complications in Brazil (PIVS)

Solventum US LLC

Status: Completed

Conditions: Infusion Site Injury

Study type: Observational

Funder types: Industry

Identifiers

NCT03719287

EM-05-014222

Details and patient eligibility

About

A multi-center, national prevalence study where: (1) baseline SPIVC therapy complications of hospitalized adult patients that meet the inclusion/exclusion criteria of the study and (2) the compliance of clinicians to the Hospital's evidence based practice will be measured in Brazil.

Full description

At each participating research site, select nurse clinicians who are experienced or experts in short peripheral I.V. catheter (SPIVC) therapy, will audit medical records and observe the SPIVC sites of adult patients in various hospital wards until a minimum total of 300 SPIVC sites are audited among 3 Brazilian acute care hospitals. The wards audited will be selected by the Investigator and will be audited during a specified time period until at least 100 SPIVCs are audited. The time to complete the study will depend on the size of the select wards, the number of nurse auditors and the number of monitoring visits required.

There are no treatments. The short peripheral I.V. catheter-related medical devices (products) observed during the study are currently approved by Brazil regulatory agencies, purchased by the hospital and available to the clinician at the time of the study.

Enrollment: 295 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subject, aged 18 years or older at the time of the study's audit of the ward;
• Subject admitted into one of the wards audited at the study site;
• Subject available for observation at the time of the audit;
• Subject with at least one inserted PIVC;
• Subject that voluntarily signed and dated the informed consent form (ICF) prior to study entry, if required by the study site's Ethics Committee.

Exclusion criteria

• Subject under treatment at the study site's outpatient clinics;
• Subject admitted into a mental health ward, emergency ward or burn unit;
• Subject awaiting transfer to another facility.

Trial design

295 participants in 3 patient groups

Hospital #1

Description:

Patients who meet inclusion criteria in the first of three participating Brazil hospitals

Hospital #2

Description:

Patients who meet inclusion criteria in the second of three participating Brazil hospitals

Hospital #3

Description:

Patients who meet inclusion criteria in the third of the three participating Brazil hospitals