Pulse Oximeter Calibration Clinical Trial
Official title:
NightOwl SpO2 Calibration Study
Calibration of a software module that computes Oxygen saturation(SpO2) based on
photoplethysmography (PPG) traces acquired by the NightOwl reflectance-based PPG sensor which
is placed on the finger.
The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of pulse oximeter equipment (ISO
80601- 2-61:2011)
1. Trial objectives The main objective of this trial is to calibrate the parameters of a
software module that computes SpO2 from the digitized raw red and infrared PPG traces of
the NightOwl sensor placed at the fingertip. A CO-oximeter subsequently analyses the
blood samples to derive "Gold-standard" SaO2 values to which the SpO2 samples can be
compared. To obtain a spectrum of SpO2 levels between 100 and 73 % of healthy subjects,
FiO2 will be progressively decreased in a hypoxia chamber under the guidance of an
anaesthesiologist.
2. Endpoints Computation of Arms, the performance metric proposed by ISO 80601-2-61:2011
Annex CC: Determination of accuracy. This metric captures the bias and precision of the
computed SpO2 values compared to the gold standard blood gas analysis method. The
software modules' SpO2 computation accuracy (defined as Arms) will first be compared
using the temporally paired oxygen saturation (SaO2) readings of the CO-oximeter
benchmark.
3. Trial Design The trial is designed as open blind, non-randomized trial for clinical data
acquisition. Approximately 10 healthy subjects will be included in the study.
Groups of up to 3 subjects will enter a hypoxia chamber. These subjects will have six
NightOwl sensors attached, one placed on the index, middle, and ring finger of each hand. For
each patient, one Nonin pulse oximeter with a real time SpO2 display will be placed on the
pinkie, such that the SpO2 values can be monitored in real time. The NightOwl will transfer
data to a smartphone, which serves as a data acquisition hub during the study. Once all
sensors have been attached and data acquisition has started, FiO2 (percentage of oxygen in
the space being measured) of the hypoxia chamber will gradually and be lowered over a course
of approximately 2 hours, under the guidance of an anaesthesiologist. The investigators will
attempt to create 5 stable plateaus of FiO2 values to allow for arterial blood sample drawing
of a stable SaO2 value. As soon as SpO2 measured by a Nonin device of any subject drops below
73% for one minute, this particular subject will leave the hypoxia chamber immediately. As
soon as all subjects have left the chamber, FiO2 will be returned to the oxygen level of the
environment. The above is repeated for the next group of subjects until the warranted number
of subjects is reached. During the procedure, for each subject, approximately 25 arterial
blood samples will be drawn from an arterial catheter, of which the exact time of extraction
will be noted.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03774199 -
NightOwl Pulse Oximeter Calibration Study
|
N/A |