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In-line Filtration Reduces Postoperative Phlebitis.

NCT03193827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2017-06-21

No results posted yet for this study

Summary

The aim of this study is to demonstrate the efficacy of in-line filtration in reducing the incidence of postoperative phlebitis associated with peripheral short-term vascular access.

In this controlled trial, 268 surgical patients are 1:1 randomised to in-line filtration (study group) and standard care (control group). The incidence of phlebitis (defined as Visual Infusion Phlebitis, VIP score≥2) within 48hrs postoperatively is compared between the two groups, as well as the onset and severity of phlebitis and the reasons for removal of the cannula. The lifespan of venous cannulae and cost-of-care are compared for the study and control groups through a Kaplan-Meier curve. Multivariate Cox regression analysis is performed to evaluate the effect of in-line filtration on risk of phlebitis and cannula removal.

Conditions

  • Phlebitis

Interventions

DEVICE

In-line filtration

In-line filtration is used during anesthesia and postoperative 96 hrs in study group to purify endovascular fluids administrations reducing postoperative phlebitis

DEVICE

Standard treatment

Patients are treated with standard intravenous solutions and vascular access management

Sponsors & Collaborators

  • Careggi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2017-06-01
Completion
2017-06-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03193827 on ClinicalTrials.gov