Sphb Haemoglobin in Vivo Validation Clinical Trial
Official title:
Validation of a Continuous Noninvasive Haemoglobin Determination Monitor (Radical 7 Pulse CO-Oximeter, SpHb) Compared to the Central Laboratory Coulter (LabHb) and a Point of Care (POC) Invasive Cooximeter (COoxHb) After in Vivo Adjustment.
Continuous haemoglobin determination could improve the outcomes of several patients in risk
of bleeding during surgery. An in vivo calibration has been introduced to the device after
our team found its need. The uncalilbrated validation of the Masimo Radical 7 continuous
haemoglobin monitor has been made in various papers, although it has been compared to point
of care devices, thus introducing an error as such point of care devices although validated
for haemoglobin determination, are not as accurate as the gold standard. The validation of
the gold standard calibrated device has not been described yet.
When compared to the accepted gold standard (cyanmethemoglobin method, Coulter), accuracy
and precision of the continuous haemoglobin monitor could be good enough to be used
interchangeably with the gold standard.
Continuous haemoglobin determination could improve the outcomes of several patients in risk
of bleeding during surgery.
The in vivo calibration has not been adjusted to the gold standard haemoglobin determination
in the literature yet.
Two blood samples will be withdrawn at the same time from an arterial line, one for the
central laboratory and the other one for the POC device. At the same exact time the SpHb
measurement will be recorded. At least eight samples are expected per patient. A maximum of
20 samples will be withdrawn per patient.
To compare bias, precision and limits of agreement among SpHb, LabHb and COoxHb the Bland
Altman method will be used with multiple observations per subject when the true value
varies. An error grid analysis will be made to know how it could affect to clinical decision
making.
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Observational Model: Case-Only, Time Perspective: Prospective