Arterial Catheter to Monitor Glycemia

Study Overview
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Brief Summary
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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.

Official Title
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Randomised Clinical Trial to Evaluate the Obtention of Blood Samples Through an Arterial Catheter to Monitor Glycose Levels

Conditions
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Critical Illness, Hyperglycemia

Intervention / Treatment
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* Procedure: Manual and automated washing of the peripherical lines
* Procedure: Automated washing of the peripherical lines


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual and automated washing of the line<br>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. | Procedure: Manual and automated washing of the peripherical lines<br>* The extractions of the blood for the analysis of the glycaemia will be made puncturing the needless connector inserted in the distal 3-way stopcock key once an hour during 48 hours. Obtain 2cc of blood using the arterial blood sampling syringe connected to the proximal key. This volume of rejection is reserved in the syringe itself. In accordance with the current protocol of disinfection, the needless connector inserted on the distal key will be disinfected. With a disposable sterile syringe the needless connector is punctured and a minimum blood amount is obtained for the determination of the glycaemia. Once the sample has been obtained, the rejection volume reserved is returned to the bloodstream. This arterial blood sampling syringe is cleaned aspirating serum manually in order to wash the line. Additional line washing is made through the fast flow valve of the system BD DTXPlus ™.<br>|
| Experimental: Automated washing of the line<br>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. | Procedure: Automated washing of the peripherical lines<br>* The extractions of the blood for the analysis of the glycaemia will be made puncturing the needless connector inserted in the distal 3-way stopcock key once an hour during 48 hours. In accordance with the current protocol of disinfection, the two needless connectors inserted on the two 3-way stopcock keys will be disinfected. With a disposable sterile syringe the needless connector on proximal 3-way stopcock is punctured and 2cc of blood are aspirated. This volume of rejection is reserved in the syringe itself and it is not disconnected. With a second disposable sterile syringe the needless connector on distal 3-way stopcock key is punctured and a minimum blood amount is obtained for the determination of the glycaemia. Once the sample has been obtained, the rejection volume reserved in the disposable syringe connected to the proximal 3-way stopcock is returned to the bloodstream. Line washing will be made through the fast flow valve of the system BD DTXPlus ™.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteremia episode originated from arterial catheter | 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. | At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local infection at cutaneous point of arterial catheter insertion | 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. | At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason) | 
| Catheter colonization | 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. | At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason) | 
| Radial artery pseudo-aneurysm | Diagnosed by the means of Doppler ultrasonography | Between 48 and 96 hours after catheter's withdrawal | 
| Ischemia or thrombosis of radial artery | Diagnosed by the means of Doppler ultrasonography | Between 48 and 96 hours after catheter's withdrawal | 
| Arterial catheter obstruction | Blood sample obtention from arterial catheter is unavailable. | From the date of arterial catheter insertion to withdrawal at seventh day or at any moment for any clinical reason | 
| Glycose blood levels |  | During the two days of catheter manipulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical illness, Hyperglycemia, Catheters, Indwelling, Intensive care unit