Arterial Catheter to Monitor Glycemia (CAT-GLIC)

Consorci Hospitalari de Vic

Status and phase: Unknown; Phase 4

Conditions: Hyperglycemia; Critical Illness

Treatments: Procedure: Automated washing of the peripherical lines; Procedure: Manual and automated washing of the peripherical lines

Study type: Interventional

Funder types: Other

Identifiers

NCT01176279

CGLIC-2007-03

Details and patient eligibility

About

The technique of blood samples extraction from the radial artery through an arterial catheter with a 3-way stopcock and automated washing with valve of fast flow is better than the one carried out through a fixed reusable arterial blood sample syringe and its manual washing because it shows a minor incidence of the complications originated from technical manipulation as infection, pseudo-aneurysm, ischemia or thrombosis of radial artery or obstruction of the catheter.

The purpose of this study is to evaluate the efficacy, in terms of adverse effects, of blood samples obtention using an arterial catheter with needless connector closed system or an arterial catheter with an arterial blood sample syringe.

Also a second purpose is to compare once a day (at the same time) the values of glycose blood levels between bedside glucometer determination of arterial catheter extraction and capillar puncture, and lab determination of glycose from venous puncture, in order to determinate fluctuation in glycose levels due to peripherical hypoperfusion or to vasoactive drugs received by these in-intensive care unit patients.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admission in intensive care unit
• Insertion of a radial artery catheter for the invasive monitoring of haemodynamic pressure for a maximum of 5 days
• Need of insulin therapy by an intravenous continuous perfusion

Exclusion criteria

• Patients who do not accept to participate (or their relatives do not accept)
• Patients with a medical limitation of effort therapy
• Patients with FloTrac sensor from Edwards Lifesciences which does not allow to add a supplementary 3-way stopcock

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Manual and automated washing of the line

Active Comparator group

Description:

Place in the radial artery the system of invasive monitoring of the blood pressure (BD DTXPlus ™). Insert in line a second 3-way stopcock above the one that has the BD DTXPlus ™; this second 3-way stopcock will be called proximal key. On the distal 3-way stopcock key (the one of TM BD DTXPlus ™), put the needless connector included in the kit to make the extractions of blood. Connect an arterial blood sampling syringe on the proximal 3-way stopcock key. With the assembled system, it is necessary to print a curve of invasive determination of the blood pressure.

Treatment:

Procedure: Manual and automated washing of the peripherical lines

Automated washing of the line

Experimental group

Description:

Place in the radial artery the system of invasive monitoring of the blood pressure (BD DTXPlus ™). Insert in line a second 3-way stopcock above the one that has the BD DTXPlus ™; this second 3-way stopcock will be called proximal key. On the distal 3-way stopcock key (the one of BD DTXPlus™), put the needless connector included in the kit to make the extractions of blood. On the proximal 3-way stopcock key put a second identical needless connector: in the intervention group the two 3-way stopcock keys have, each one, a needless connector. With the assembled system, it is necessary to print a curve of invasive determination of the blood pressure.

Treatment:

Procedure: Automated washing of the peripherical lines