Determination of SpO2 and PR Accuracy Specifications at Rest (71Ag_Vital-0031)

Condition(s) studied

Investigational drug(s) / intervention(s)

Pulse oximeter: OLV-4202 pulse oximeter (SW version: 01-12)

Study summary

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest

Eligibility

Primary outcome measure(s)

• Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at varying desaturation levels (70% to 100%) — 30 minutes
  Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed. Run 1 stabilized room air period -\> stabilized plateaus at saturation level targets: room air, 92%, 87%, 82%, 77%, 72% Run 2 stabilized 100% O2 period -\> stabilized plateaus at saturation level targets: 100%, 93%, 88%, 83%, 78%, 73% SpO2 is observed breath by breath arterial saturation, which is in turn computed from end tidal PO2 and PCO2. FiO2 is reduced suddenly at first then adjusted to achieve a stable plateau value at the desired target. Each desaturation plateaus should not exceed 10 minutes. A blood draw is taken at stable FiO2 and +30 seconds. The gas mixture is then changed for the next value and repeated for each plateau value.
• Root-mean-square (Rms) of device Pulse Rate measurement with room air stabilization is within +-3 [1/min] of reference ECG Pulse Rate measurement at heart rates (30 to 300 [1/min]) — 30 minutes
  Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed. Run 1 stabilized room air period -\> stabilized plateaus at saturation level targets: room air, 92%, 87%, 82%, 77%, 72% Run 2 stabilized 100% O2 period -\> stabilized plateaus at saturation level targets: 100%, 93%, 88%, 83%, 78%, 73% Pulse rate is recorded from the test device and from the reference ECG monitor. PR data measurements are gathered during the stable plateau value at the desired saturation target. Each desaturation plateaus should not exceed 10 minutes. The gas mixture is then changed for the next value and repeated for each plateau value.

Trial sites (1)

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