To show accurate and proper functioning of the Medimate Lithium Analyzer
ID
Source
Brief title
Condition
- Exposures, chemical injuries and poisoning
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
From the measurements the correlation between the measurement systems, the
accuracy and liability are calculated.
After 8 weeks the investigator will notify the METC on the results. If the
study ends premature, than the METC will be notified within 15 days. A final
report will be submitted within one year.
Secondary outcome
not applicable
Background summary
Medimate has developed a point of care lithium analyzer. Using disposable
microchips patients can now test their lithium level at home with one droplet
of blood. The hypothesis is that the Medimate system has comparable accuracy
compared to commonly used laboratory equipment. This system enables diagnostics
at the point of care and patients will benefit form better control of their
lithium value when using this system.
Study objective
To show accurate and proper functioning of the Medimate Lithium Analyzer
Study design
Correlation study between validated laboratory equipment for lithium analysis
and Medimate Lithium Analyzer. Results of whole blood fingerprick sample taken
at the same instant as venous sample for laboratory equipment are to be
compared. Statistical information is found by using Students t number at an
accuracy of 95%. For showing good correlation 5 patients are calculated to be
sufficient. However, to show good linearity in the necessary range, between 0.6
and 1.2 mM, 10 patients are chosen. For the precision of each measurements at a
specific lithium value 16 measurements are calculated to be sufficient to
measure the mean with a confidence interval of +/- 0.05 mM at a standard
deviation of 0.1. Therefore 16 measurements per patient are chosen.
10 patients with variable lithium concentrations are to be measured. Each
patients will be measured 16 times by using in total 6 finger prick
measurements per patient during 1 day. About 5 minutes prior to the first
finger prick measurements a venous puncture will be realized and blood will be
measurement according to standard clinical procedure. The time necessary per
patient is 20-30 minutes. All measurements will be done during regular hospital
visits.
Study burden and risks
The study will be conducted according to the Declaration of Helsinki
(09.10.2004) and in accordance with the Medical Research Involving Human
Subjects Act (WMO)
Two places of risks are identified. Firstly, the moment of taking a finger
prick; this is done by experts from the hospital and is according to standard
self monitoring by glucose measurements. Secondly the moment of placing the
blood on the chip; all materials used in the chip indicate no hazardous risks
to the patient or handling person according to Directive 67/548/EEC.
De Veldmaat 10
7522 NM Enschede
Nederland
De Veldmaat 10
7522 NM Enschede
Nederland
Listed location countries
Age
Inclusion criteria
On lithium medication
Exclusion criteria
Not able to read or speak Dutch
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 | NL17372.044.07 |