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

July 29, 2022 updated by: 3M

National, Cross-sectional, Multicenter Study to Estimate the Point Prevalence of Peripheral Intravenous Catheter-related Complications in Brazil: a Quality Improvement Study (PIVS)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

295

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Universidade Federal de Sao Paulo
    • Parana
      • Curitiba, Parana, Brazil
        • Hospital Erasto Gaertner (HEG)
    • Sao Paolo
      • Campinas, Sao Paolo, Brazil, 13034-685
        • Centro de Pequisa Clinica Sao Lucas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to the wards of the participating acute care hospitals that will be audited in the study. To minimize subject selection bias, all subjects will be identified and invited to participate in the study consecutively, as the auditor screens the ward on the day of the audit.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hospital #1
Patients who meet inclusion criteria in the first of three participating Brazil hospitals
Hospital #2
Patients who meet inclusion criteria in the second of three participating Brazil hospitals
Hospital #3
Patients who meet inclusion criteria in the third of the three participating Brazil hospitals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of PIVCs Sites With at Least One Clinical or Mechanical Complication (PIVC-related Complications)
Time Frame: 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
From PIVC insertion to the audit, up to 7 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of PIVC Sites With at Least One Clinical and One Mechanical Complication (PIVC-related Clinical and Mechanical Complications).
Time Frame: 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.
From PIVC insertion to the audit, up to 7 days.
Percentage of PIVC Sites With at Least One Clinical Complication
Time Frame: 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
From PIVC insertion to the audit, up to 7 days.
Percentage of PIVC Sites With at Least One Mechanical Complication
Time Frame: 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
From PIVC insertion to the audit, up to 7 days.
Percentage of PIVC Sites With at Least One Related Quality Issue
Time Frame: 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
From PIVC insertion to the audit, up to 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3M

Collaborators

Eurotrials Brasil Consultores Cientificos Ltda

Investigators

  • Principal Investigator: Joaquim Simoes Neto, MD, Centro de Pequisa Clinica Sao Lucas
  • Principal Investigator: Larissa S Victor, RN, Hospital Erasto Gaertner (HEG)
  • Principal Investigator: Ariane F Machado Avelar, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • EM-05-014222

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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