Measuring ionized calcium in blood, urine and saliva.
Research type
Research Study
Full title
Prospective, single arm study of equivalence between concentrations of ionized and total calcium in venous and capillary blood, urine and saliva measured on the main platform (Roche Calcium Gen.2) and Point of Care Devices (iSTAT and LAQUA twin Ca prototype) and their correlation with symptoms of hypocalcaemia in patients undergoing thyroid and parathyroid surgery at UCLH.
IRAS ID
236079
Contact name
Tom Kurzawinski
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2019/07/131, UCL Data Registration number
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
At least 1 in 5 patients that undergo thyroid and parathyroid surgery develop low calcium in the blood. This can cause acute symptoms of paraesthesia or muscle spasms and long term complications such as soft tissue calcification and psychiatric problems.
After surgery, calcium needs to be measured frequently both in and out of the hospital. Currently, 10 ml of venous blood is send to the main laboratory for analysis, an inefficient and slow process, which delays diagnosis and treatment.
There is an urgent need to develop a simple Point of Care testing device able to measure calcium concentration without delay either at the hospital bedside or at home.
LAQUAtwin is a handheld device designed to measure ionized calcium in water and soil. The modified LAQUAtwin Calcium prototype would allow testing for either venous or capillary blood calcium concentration in one minute with instantly available results. It can also measure calcium in urine or saliva samples.
Our study will assess ability of LAQUAtwin Ca prototype to measure ionized calcium in blood, urine and saliva in 30 patients undergoing thyroid and parathyroid surgery at UCLH. These measurements will be compared to current “gold standard” methods such as total calcium concentration performed by the main laboratory and i-STAT Analyzer. Correlation between symptoms and calcium concentrations will be assessed by asking patients to grade their symptoms using specially designed questionnaire.
The results of the study will be used to design and built new device able to measure calcium accurately, simply, quickly and cost efficiently, to the great benefit of patients and health care providers.REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/1740
Date of REC Opinion
27 Mar 2020
REC opinion
Further Information Favourable Opinion