Arterial Catheter to Monitor Glycemia

Phase 4

• Conditions: Critical Illness; Hyperglycemia
• Interventions: Procedure: Automated washing of the peripherical lines; Procedure: Manual and automated washing of the peripherical lines

• Registration Number: NCT01176279
• Lead Sponsor: Consorci Hospitalari de Vic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Status Verified: 2010-07
• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-05
• Last Update Submitted: 2010-08-05
• Study First Posted: 2010-08-06
• Last Update Posted: 2010-08-06
• Primary Completion: 2011-07
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated washing of the line	Automated washing of the peripherical lines	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.
Manual and automated washing of the line	Manual and automated washing of the peripherical lines	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.

Primary Outcome Measures

Name	Time	Method
Bacteremia episode originated from arterial catheter	At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)	Catheter-related bloodstream infection as defined in Appendix A of "Guidelines for the Prevention of Intravascular Catheter-Related Infections". Centers for disease control and prevention (CDC) 2002 August 9: 51(RR10); 27.

Secondary Outcome Measures

Name	Time	Method
Arterial catheter obstruction	From the date of arterial catheter insertion to withdrawal at seventh day or at any moment for any clinical reason	Blood sample obtention from arterial catheter is unavailable.
Radial artery pseudo-aneurysm	Between 48 and 96 hours after catheter's withdrawal	Diagnosed by the means of Doppler ultrasonography
Glycose blood levels	During the two days of catheter manipulation
Catheter colonization	At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)	Localized catheter colonization as defined in Appendix A of "Guidelines for the Prevention of Intravascular Catheter-Related Infections". Centers for disease control and prevention (CDC) 2002 August 9: 51(RR10); 27.
Local infection at cutaneous point of arterial catheter insertion	At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)	Exit site infection as defined in Appendix A of "Guidelines for the Prevention of Intravascular Catheter-Related Infections". Centers for disease control and prevention (CDC) 2002 August 9: 51(RR10); 27.
Ischemia or thrombosis of radial artery	Between 48 and 96 hours after catheter's withdrawal	Diagnosed by the means of Doppler ultrasonography

Trial Locations

Locations (1)

Vic Hospital Consortium - Consorci Hospitalari de Vic; 🇪🇸 Vic, Catalonia, Spain