1. No category

Technology
ALERT
Horizon Scanning Centre
February 2015
CoSense® End Tidal Carbon Monoxide
monitor for neonatal haemolytic
disease
TECHNOLOGY
CoSense® End Tidal Carbon Monoxide (ETCO) monitor
developed by Capnia, Inc. is a portable, non-invasive device
for the detection of haemolysis in neonates. The CoSense
test is for use soon after birth and at additional time points as
necessary to monitor the rate of haemolysis.
Cosense® measures ETCO by drawing a sample of gas from
the patient’s breath through a CoSense® Precision Sampling
Set, one end of which is inserted into one nostril and the
other end connects to the CoSense® device. As the breath
sample is drawn from the patient the device selects a valid
physiologic breath, segments the breath into different parts
and collects a gas sample from the end tidal portion of that
breath using an algorithm. This sample is transferred to an
© Capnia, inc.
electrochemical carbon monoxide (CO) sensor, which
measures the amount of CO in the sample in parts per million. Acquisition of the sample
takes less than a minute, and within another 3 minutes a result is provided on a touch screen
to the user.
The ETCO value measured by the CoSense® device can be used for the detection of
haemolysis. In particular, it can help risk stratify newborns where the presence of haemolysis
with jaundice is a predictor of adverse neurological outcomes such as low IQ, auditory
abnormalities and kernicterus. It can also determine which babies are at higher risk and may
need better monitoring or quicker treatment.
The CoSense® device received a CE mark in August 2013 and is expected to be launched
into NHS clinical use in July 2015.
This alert presents independent research funded by the National Institute for
Health Research (NIHR). The views expressed are those of the author and
not necessarily those of the NHS, the NIHR or the Department of Health.
NIHR Horizon Scanning Centre, University of Birmingham
Email: nihrhsc@contacts.bham.ac.uk
Web: www.hsc.nihr.ac.uk
NIHR Horizon Scanning Centre
POTENTIAL FOR IMPACT
Haemolysis is the rupturing of red blood cells (RBCs) and the release of their contents into
surrounding fluid (e.g. blood plasma). As the RBCs disintegrate, the haemoglobin is broken
into globin, iron and haem. When haem is catabolised, bilirubin and CO
are produced. Excess bilirubin production in a newborn can lead to its accumulation in the
brain with consequent irreversible damage manifesting as neurological deficits, seizures,
abnormal reflexes and eye movements.
Investigation of haemolysis in a neonate includes testing its blood for bilirubin levels, red
blood cell count, peripheral smear and antibodies (Coombs test). This might involve
repeated blood sampling over a period of time. The company claims that measuring CO
levels using the CoSense® device can detect haemolysis with a non-invasive breath test,
which is simple to use and minimal training is required. The company also claims a key
innovative feature of the CoSense® device is that a valid breath sample can be collected and
analysed using an algorithm in circumstances of very high and irregular breath rates in
neonates. This is important as neonates cannot follow instructions required in other breath
diagnostic devices.
The company claims that newborns with haemolysis can be identified earlier and more
accurately using the Cosense® ETCO monitor. They can then be treated with phototherapy
at lower levels of bilirubin. Conversely, if there is no haemolysis, newborns can be managed
with a higher threshold for treatment, discharged early or receive less rigorous follow-up. It is
anticipated that blood tests to detect haemolysis would not be performed in the vast majority
of cases, and would be replaced with the Cosense® device.
If proven effective, the CoSense® device should provide a non-invasive method to measure
ETCO, which can be used to identify newborns with jaundice who at a higher risk of
developing adverse neurodevelopmental outcomes. This may allow doctors to better plan inpatient and post-discharge care.
This technology is predicted to have an impact on the following domain(s) of the NHS
Outcomes Framework (www.england.nhs.uk/resources/resources-for-ccgs/out-frwrk):
Domain 1
Preventing people from dying prematurely;
Domain 3
Helping people to recover from episodes of ill health or following injury;
EVIDENCE
PUBLISHED PAPERS AND ABSTRACTS
Christensen RD, Lambert DK, Henry E et al. End-tidal carbon monoxide as an indicator of
the hemolytic rate. Blood Cells, Molecules, and Diseases 2014.
http://www.ncbi.nlm.nih.gov/pubmed/25624169.
Cuadrado MEC, Vreman HJ, Wong RJ et al. From bench to bedside: evaluation of a new
end-tidal carbon monoxide monitor to identify hemolysis in infants. Pediatrics Academic
Societies Meeting. May 2014. Poster presentation.
http://www.abstracts2view.com/pas/view.php?nu=PAS14L1_4112.242
Du L, Zou P, Chen L et al. Exhaled end-tidal carbon monoxide testing for hemolysis in
neonates with significant hyperbilirubinemia and positive direct anti-globulin test. Pediatrics
Academic Societies Meeting. May 2014. Poster presentation.
http://www.abstracts2view.com/pas/view.php?nu=PAS14L1_4112.247
2
NIHR Horizon Scanning Centre
Lal A, Patterson L, Goldrich A et al. Detection of elevated end-tidal carbon monoxide
concentration in children with sickle cell anemia. Pediatrics Academic Societies Meeting.
May 2014. Poster presentation.
http://www.abstracts2view.com/pas/view.php?nu=PAS14L1_4100.14
COMPLETED UNPUBLISHED STUDIES
Measuring end-tidal carbon monoxide of neonates who have severe jaundice, using a rapid,
painless, and non-invasive technique. Study 1040173.
INFORMATION FROM
This Alert is based on information from the company and a time-limited internet search.
3