To compare pulse oximetry saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.
The study utilizes a single-site, physiology laboratory (Clinimark) to conduct this Post Market, non-randomized, prospective studies. The goal is to enroll a minimum of fifteen subjects. Subject pool goal of diversity across ethnicity, race and sex of varying skin tones to meet the study design requirements. The general purpose of Invasive Controlled Desaturation Studies is to support the SpO2 accuracy of the post market pulse oximetry sensors and paired monitor in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during low saturation conditions. This is achieved through paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of 60% to 100% SaO2 of the pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steady-state saturation periods. Arterial blood samples are periodically taken from an indwelling arterial catheter for use in the comparison. Pulse rate accuracy will be evaluated during the same data collection period as SpO2. Pulse rate will be compared to reference ECG heart rate.
Study Type
OBSERVATIONAL
Enrollment
15
Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples are collected at targeted levels of saturation.
Clinimark
Louisville, Colorado, United States
Comparison of pulse rate (BPM) by a pulse oximeter monitor and sensor, compared to ECG pulse rate measurement
To validate the proposed claims for pulse rate (BPM) accuracy in diverse subject population during Low Saturation over a specified saturation ranges.
Time frame: October 2022
Comparison of SPO2 saturation levels by a pulse oximeter to saturation measurements made by a multi-wavelength CO-oximeter.
To validate the proposed claims for SPO2 saturation accuracy in diverse subject population during Low Saturation over a specified saturation ranges.
Time frame: October 2022
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.