Midline Programme - Vascular Nursing Team

Integration of the Vascular Nursing Team of the Department of Haematooncology, University Hospital Ostrava for the needs of all clinical departments of the hospital. Assessment of local signs of inflammation in patients of the Department of Haematooncology and other clinical departments of the University Hospital Ostrava.

Study Overview

• Status: Completed
• Conditions: Inflammation; Local; Infection
• Intervention / Treatment: Device: Midline catheter

Detailed Description

The study subjects were indicated by a physician for Midline catheter insertion.

Prior to insertion of the catheter, the study subjects were fully informed and signed the informed consent with participation in the study.

Local signs of inflammation were recorded in the study subjects, together with basic demographic characteristics (age, sex, diagnosis), and complications during catheter insertion, the number of days when the Midline catheter was inserted, number of changes of the dressings, presence of neutropenia in the study subjects and the score of local inflammation according to Madonna.

• Degree 0- no pain or reaction in the surrounding
• Degree 1 - pain only, no reaction in the surrounding
• Degree 2 - pain and reddening
• Degree 3 - pain, reddening, swelling or painful stripe along the vein
• Degree 4 - puss, swelling, reddening and painful stripe along the vein The investigators also observed on which day the first signs of infection appeared.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Czechia
  • Czech Republic
    • Ostrava-Poruba, Czech Republic, Czechia, 708 52
      • University Hospital Ostrava

Participation Criteria

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

Patients with Midline catheter hospitalized at clinical department of the University Hospital Ostrava, Czech Republic

Description

Inclusion Criteria:

• insertion of Midline catheter by nurses from the Vascular Nursing Team
• age over 18 years

Exclusion Criteria:

- inability to insert the Midline catheter

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neutropenia patients, Dept. of Haematooncology; Patients with neutropenia from the Department of Haematooncology were included in this group.	Device: Midline catheter; Midline catheter is used for administration of intravenous therapy, and is inserted in a larger vein.
No neutropenia patients, Dept. of Haematooncology; Patients without neutropenia from the Department of Haematooncology were included in this group.	Device: Midline catheter; Midline catheter is used for administration of intravenous therapy, and is inserted in a larger vein.
No neutropenia patients, other clinical depts.; Patients with neutropenia from the other clinical departments of the University Hospital Ostrava were included in this group.	Device: Midline catheter; Midline catheter is used for administration of intravenous therapy, and is inserted in a larger vein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local signs of infection	Local signs of infection were recorded, using the scoring system according to Madonna - see detailed description.	3 days at minimum

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Kateřina Hašová, Mgr., University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: March 10, 2019
• First Submitted That Met QC Criteria: March 10, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Midline catheter; Vascular nursing team
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: KHO-02-Midline; RVO-FNOs/2017 (Other Grant/Funding Number: University Hospital Ostrava)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators have decided not to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No