Comparison between two types of peripheral vein catheter

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-48z55v
• Date of registration: 24/03/2017
• Prospective Registration: No
• Primary sponsor: Universidade Federal do Paraná
• Public title: Comparison between two types of peripheral vein catheter
• Scientific title: Effectiveness of peripheral venous catheter
• Date of first enrolment: 21/09/2015
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-48z55v
• Study type: Intervention
• Study design: Prevention trial, parallel, open, randomized controlled with two arms.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Gabriella Lemes Rodrigues de Oliveira
• Affiliation: Universidade Federal do Paraná

• Name: Gabriella Lemes Rodrigues de Oliveira
• Affiliation: Universidade Federal do Paraná

Key inclusion & exclusion criteria

Inclusion criteria: Age over 18 years; being hospitalized in research units; requires obtaining peripheral intravenous access for intravenous therapy.
Exclusion criteria: Present peripheral venous fragility or any other condition that could impair the puncture with peripheral intravenous catheter; insertion of the catheter in the external jugular vein; have previously participated in the search, regardless of randomization group.


Age minimum: 18Y
Age maximum: 100Y
Gender: -

Health Condition(s) or Problem(s) studied

E04.555.720

H01.770.644.145.360.500

C23.550.340

E05.325.095

M01.060.116

Pathological conditions, signs and symptoms. Adult; Catheterization Peripheral; Comparative effectiveness research; /complications; phlebitis; infiltration; traction; extravasation of diagnostic and therapeutic materials; catheter obstruction; infection.

C01.539

Q35.020

SP4.021.197.118.504

C14.907.617.718

E02.148.224

Intervention(s)

Device

E02.148.224

E02.319.267.082.500

The sample size calculation, coming from a pilot test, pointed the minimum requirement of 74 adult patients admitted to medical units for each group researched. A catheter was only evaluated by the patient, since its insertion to removal of the same (range one to 22 days).Puncture and handling of catheters was held exclusively by the nursing staff, properly trained to do so.

Experimental group: we included 90 adult patients of both genders, who used peripheral intravenous catheter with closed infusion system.

Control group: we included 95 patients of both genders, in use of short flexible catheter (habitual use in the studied hospital) in the peripheral catheterization for intravenous infusions.

Primary Outcome(s)

The expected outcomes are the primary are local complications of peripheral venous catheterization, verified through direct observation of the devices, as well as reading the records in physical records. The incidence of complications is detected based on literature Phillips (2001) and Infusion Nurses Society (INS, 2016).

Secondary Outcome(s)

Measurement and comparison of the length of stay in days of catheters in each group researched, free of complications, by direct observation of the devices and reading the records. Analysis of risk factors associated with local complications resulting by statistical calculations with the aid of SPSS program. Analysis of the findings outcomes is being performed.

Source(s) of Monetary Support

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Secondary Sponsor(s)

Hospital de Clínicas da Universidade Federal do Paraná