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Completed

NCT Number: NCT03719287

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

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.

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Key information

Conditions

Infusion Site Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Erasto Gaertner (HEG), Curitiba, Paraná, Brazil

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M
  • Eurotrials Brasil Consultores Cientificos Ltda

Registry information

Official study title

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

Acronym: PIVS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2018
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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