SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study
Condition: Hypoxia; Desaturation of Blood
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft
      Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation
      during hypoxic state throughout motion and non-motion conditions under one system
      configuration.

      The purpose of this Non-Randomized, Prospective,Observational study is to conduct a hypoxia
      study to directly compare a prototype OxySoft pulse oximeter system to arterial oxygen
      saturation.
    

Detailed description: 
      The study utilizes a single-site, physiology laboratory for non-randomized, prospective,
      interventional studies. The goal is to enroll a range of twelve (12) to sixteen (16) healthy
      adult volunteers. Subjects may be of any race,ranging in pigmentation from light to dark to
      meet the study design requirements.

      The general purpose of Invasive Controlled Desaturation Studies during motion is to validate
      the SpO2and pulse rate accuracy in comparison to reference-standard measurements of blood
      SaO2 by a CO-oximeter during motion conditions. This is achieved through paired observations
      of SpO2 and SaO2values over the specified SpO2 accuracy range of 70 % to 100 % SaO2 of the
      prototype 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.In the unlikely event that the ECG monitor
      malfunctions, the Pulse rate reference may be taken using the average pulse rate value from
      the transfer standard pulse oximeters. This study is designed to support an FDA submission
      for pulse rate and saturation accuracy in a diverse subject population during motion
      conditions over a specified saturation range for the Oxysoft pulse oximetry system.

      The FDA Guidance Document for Pulse Oximeters and ISO 80601-2-61 define the accepted
      guideline for evaluation and documenting the SpO2 accuracy in humans. The OxySoft sensor is
      not FDA approved for the intended study population, healthy adults. To support the
      development of Nellcor pulse oximeter systems, data is required to test the performance of
      the sensors with pulse oximetry systems in the adult patient population. In order to
      accurately validate sensors, manipulation of oxygen and nitrogen levels through the
      administration of oxygen and nitrogen gas will occur. Measurements of SpO2and pulse rate
      accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter
      during motion and non-motion conditions will be taken and analyzed to support development of
      Nellcor technology and support FDA submission.
    

Intervention name(s): Non-Invasive Controlled Hypoxia; Introduction of Motion conditions: tapping or rubbing
Intervention type(s): Device; Other
Intervention description(s): 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.; Standard motions include tapping or rubbing at periodic intervals with amplitudes of 1-2 cm and 1-4 Hz with a random variation in frequency will occur at each plateau. Each plateau will have both an interval of tapping and rubbing. Signals are recorded by a validated, computerized data acquisition system (CAS). The device values are sampled once per second and averaged over the time taken to draw the blood sample, taking into account circulation time delays and differences in device response times
Other intervention name(s): Desaturation; Blood Sampling
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will be a minimum of twelve subjects, ranging in pigmentation from
        light to dark to skin tones including subjects with deep pigmentation and the subject
        selection will be an equitable distribution of males and females.
      
Keywords: Oxygen Saturation; Invasive Controlled Desaturation