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

Completed

• Conditions: Infusion Site Injury

• Registration Number: NCT03719287
• Lead Sponsor: Solventum US LLC

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Study Start: 2019-01-07
• Primary Completion: 2019-07-31
• Study Completion: 2019-10-01
• Results First Submitted: 2021-02-22
• Results First Submitted QC: 2022-07-29
• Results First Posted: 2022-08-02
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of PIVCs Sites With at Least One Clinical or Mechanical Complication (PIVC-related Complications)	From PIVC insertion to the audit, up to 7 days.	Clinical complications are: phlebitis (grade 1-4), Hematoma, Ecchymosis, Skin injury, Local infection. Mechanical complications are: Catheter dislodgement, Occlusion, Extravasation, Infiltration (grade 1-4), Leaking at the insertion site.; Prevalence (%) = (Number of audited PIVC sites with at least one clinical or mechanical complication ÷ Number of audited PIVC sites) x 100

Secondary Outcome Measures

Name	Time	Method
Percentage of PIVC Sites With at Least One Clinical and One Mechanical Complication (PIVC-related Clinical and Mechanical Complications).	From PIVC insertion to the audit, up to 7 days.	Clinical complications are: phlebitis (grade 1-4), Hematoma, Ecchymosis, Skin injury, Local infection. Mechanical complications are: Catheter dislodgement, Occlusion, Extravasation, Infiltration (grade 1-4), Leaking at the insertion site.; Prevalence (%) = (Number of audited PIVC sites with at least one clinical and one mechanical complication ÷ Number of audited PIVC sites) x 100 PIVC sites with at least one clinical complication and one mechanical complication as well.
Percentage of PIVC Sites With at Least One Clinical Complication	From PIVC insertion to the audit, up to 7 days.	Specific clinical complications are: phlebitis (grade 1 - 4), Hematoma, Ecchymosis, Skin injury, Local infection.; Prevalence (%) = (Number of audited PIVC sites with at least one clinical complication ÷ Number of audited PIVC sites) x 100
Percentage of PIVC Sites With at Least One Mechanical Complication	From PIVC insertion to the audit, up to 7 days.	Mechanical complications are: Catheter dislodgement, Occlusion, Extravasation, Infiltration (grade 1-4), Leaking at the insertion site.; Prevalence (%) = (Number of audited PIVC sites with at least one mechanical complication ÷ Number of audited PIVC sites) x 100
Percentage of PIVC Sites With at Least One Related Quality Issue	From PIVC insertion to the audit, up to 7 days.	Quality Issues are: Unstable PIVC, Blood reflux,Uncontrolled IV infusion rate,Site dressing partially detached, Site dressing totally detached (site exposed to environment), Medical tape added to dressing edges, Unclean dressing, discomfort at insertion site with and without palpation, uncovered tubing access port, lack of visibility at the PIVC site.; Prevalence (%) = (Number of audited PIVC sites with at least one related quality issue ÷ Number of audited PIVC sites) x 100

Trial Locations

Locations (3)

Centro de Pequisa Clinica Sao Lucas; 🇧🇷 Campinas, Sao Paolo, Brazil

Hospital Erasto Gaertner (HEG); 🇧🇷 Curitiba, Parana, Brazil

Universidade Federal de Sao Paulo; 🇧🇷 São Paulo, Brazil