N/A N=295

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

Infusion Site Injury

Bottom Line

View on ClinicalTrials.gov: NCT03719287 ↗

Enrolled (actual)

295

Serious AEs

0.0%

Results posted

Aug 2022

Primary outcome: Primary: Percentage of PIVCs Sites With at Least One Clinical or Mechanical Complication (PIVC-related Complications) — 10; 6; 7 percentage of PIVC sites

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Solventum US LLC
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of PIVCs Sites With at Least One Clinical or Mechanical Complication (PIVC-related Complications)	10; 6; 7	—
SECONDARY Percentage of PIVC Sites With at Least One Clinical and One Mechanical Complication (PIVC-related Clinical and Mechanical Complications).	0; 0; 1.0	—
SECONDARY Percentage of PIVC Sites With at Least One Clinical Complication	7.0; 5.0; 5.0	—
SECONDARY Percentage of PIVC Sites With at Least One Mechanical Complication	3.0; 1.0; 3.0	—
SECONDARY Percentage of PIVC Sites With at Least One Related Quality Issue	61; 91; 77	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03719287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.