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Arterial Catheter to Monitor Glycemia

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01176279
Acronym
CAT-GLIC
Enrollment
100
Registered
2010-08-06
Start date
2008-04-30
Completion date
2011-12-31
Last updated
2010-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Hyperglycemia

Keywords

Critical illness, Hyperglycemia, Catheters, Indwelling, Intensive care unit

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.

Interventions

PROCEDUREManual and automated washing of the peripherical lines

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 ™.

PROCEDUREAutomated washing of the peripherical lines

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 ™.

Sponsors

Consorci Hospitalari de Vic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bacteremia episode originated from arterial catheterAt 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

MeasureTime frameDescription
Catheter colonizationAt 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.
Radial artery pseudo-aneurysmBetween 48 and 96 hours after catheter's withdrawalDiagnosed by the means of Doppler ultrasonography
Local infection at cutaneous point of arterial catheter insertionAt 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.
Arterial catheter obstructionFrom the date of arterial catheter insertion to withdrawal at seventh day or at any moment for any clinical reasonBlood sample obtention from arterial catheter is unavailable.
Glycose blood levelsDuring the two days of catheter manipulation
Ischemia or thrombosis of radial arteryBetween 48 and 96 hours after catheter's withdrawalDiagnosed by the means of Doppler ultrasonography

Countries

Spain

Contacts

Primary ContactPere Roura-Poch, MD
proura@chv.cat+34.937.02.77.13

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026