The objective of this study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in critically ill patients.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Glucose prediction error, defined as [the YSI (the "gold standard") versus
the OptiScanner result, as well as all other measurement technologies used on
central venous blood].
* Clarke Error Grid analysis between the YSI and the OptiScanner result, to
show the percentage of paired data values falling within each zone.
* Linearity between the YSI and the OptiScanner, as well as all other
measurement technologies used on central venous blood.
Secondary outcome
* Glucose prediction error, defined as [the YSI versus all other measurement
technologies used on arterial blood].
* Clarke error grid analysis between the YSI and all other measurement
technologies used on arterial blood.
* Linearity between the YSI and all other measurement technologies used on
arterial blood.
Background summary
Critically ill patients frequently have hyperglycemia. Blood glucose control
with insulin prevents hyperglycemia but is associated with a higher incidence
of hypoglycemia and may even increase blood glucose variability. Both are
associated with adverse effects.
Blood glucose control with insulin utilizing manual systems for glucose
measurement is blood*consuming, since frequent blood draws for glucose
measurements are necessary in order to achieve adequate blood glucose control.
OptiScan Biomedical Corporation has developed a glucose monitoring technology,
called the OptiScanner, that measures the infrared absorption of glucose in a
very small sample of heparinized plasma, created from approximately 120 uL of a
patient*s blood.
The OptiScanner has been safe in healthy volunteers and patients outside the
Intensive Care unit.
Study objective
The objective of this study is to demonstrate the accuracy of the OptiScanner
in measuring blood glucose levels in critically ill patients.
Study design
Every 15 minutes the OptiScanner collects a little amount of blood - every 4
hours an extra blood sample will be collected from the same central catheter
for comparison. Results of these measurements will not be used to titrate
insulin.
Study burden and risks
It is standard practice to collect blood from an indwelling arterial line for
blood glucose measurement once every 4 hours - this will not be changed in this
study and remains the way to monitor blood glucose levels and titrate insulin.
The test patient will not be aware of the measurements: the Optiscanner is
connected to an existing central venous line; there is no need for extra
catheters, and blood will not be collected via extra venapunctures.
In total, 22 mL blood will be collected per day - this amount is negligible. In
addition, on 3 successive days an extra blood sample of 4 mL will be collected
- this amount is also negligible.
The total amount of saline that is used to return back the remainder of the
blood sample + the amount of saline to keep the line open is less than 350 mL
per day, which is also considered clinically insignificant.
Meibergdreef 9
Amsterdam, Nederland
NL
Meibergdreef 9
Amsterdam, Nederland
NL
Listed location countries
Age
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).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34465.018.10 |
| Other | volgt |