Manual vs. Automated moNitoring Accuracy of GlucosE (MANAGE)

Conditions: Critical illness associated hyperglycemia
10018424

Registration Number: NL-OMON34611

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

* Informed consent.
* Age > 18 years.
* Admitted to the ICU of the Academic Medical Center.
* Expected ICU stay of * 3 days at the time of enrolment (as judged by Principle Investigator).
* APACHE II score of * 10.
* Existing central venous catheter + arterial catheter.
* No participating in any other investigational interventional study while enrolled in this study.

Exclusion Criteria

* Have received any investigational product or been treated with an investigational device within the past 30 days.
* Pregnancy.
* Untreatable colonization with multi*resistant bacteria (e.g., methicillin*resistant Staphylococcus aureus).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Glucose prediction error, defined as [the YSI (the gold standard) versus<br /><br>the OptiScanner result, as well as all other measurement technologies used on<br /><br>central venous blood].<br /><br>* Clarke Error Grid analysis between the YSI and the OptiScanner result, to<br /><br>show the percentage of paired data values falling within each zone.<br /><br>* Linearity between the YSI and the OptiScanner, as well as all other<br /><br>measurement technologies used on central venous blood.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Glucose prediction error, defined as [the YSI versus all other measurement<br /><br>technologies used on arterial blood].<br /><br>* Clarke error grid analysis between the YSI and all other measurement<br /><br>technologies used on arterial blood.<br /><br>* Linearity between the YSI and all other measurement technologies used on<br /><br>arterial blood.</p><br>