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NCT03871010 Clinical Trial

Midline Programme - Vascular Nursing Team

Inflammation Clinical Trial

Official title:
Midline Programme - Vascular Nursing Team

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03871010
Other study ID # KHO-02-Midline
Secondary ID RVO-FNOs/2017
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date April 30, 2020

Study information
Verified date October 2020
Source University Hospital Ostrava
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Midline catheter
Midline catheter is used for administration of intravenous therapy, and is inserted in a larger vein.

Locations
Country Name City State
Czechia University Hospital Ostrava Ostrava-Poruba Czech Republic

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

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