Wireless Disposable SpO2 Sensor Hypoxia Testing

Not Applicable

Completed

Conditions: SpO2
Peripheral Oxygen Saturation Measurement

Interventions: Device: SpO2 Sensor Testing

Registration Number: NCT06211530

Lead Sponsor: GE Healthcare

Brief Summary: The purpose of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data on human participants.

Detailed Description: The primary objective of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data (simulating blood sample Spo2) on adult human subjects. Transfer standard is a validated pulse oximetry equipment with a calibration directly traceable to CO-oximetry. Test method and protocol is developed according to ISO 80601-2-61:2017 annex EE.3 (PROCEDURE for non-invasive laboratory testing on healthy adult volunteers) The safety objective is to collect safety information, including type and number of AEs, SAEs, and device issues.

This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

Inclusion Criteria

Participant is adult 18-50 years of age.
Biological Male or female of any race
Participant is a non-smoker or who has not smoked within 2 days prior.
Participant must have the ability to understand and provide written informed consent.
Participant is adult must be willing and able to comply with study procedures and duration.

Exclusion Criteria

Participant is considered as being morbidly obese (defined as BMI greater than 39.5)
Compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular sites utilized).
Tattoo in the optical path which would limit the ability to test sites needed for the study.
Females who are pregnant - confirmed by self-performed and self-reported positive urine pregnancy test performed on the day of the study unless the participant is known to be not of child-bearing potential
Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels greater than 3% as assessed per site standard operation procedure.
Participants with self-reported respiratory conditions such as: uncontrolled/severe asthma, flu, pneumonia/bronchitis, shortness of breath/respiratory distress, unresolved respiratory or lung surgery, emphysema, COPD, lung disease, and/or recent COVID (last 2 months).
Participants with self-reported heart or cardiovascular conditions such as: cardiovascular surgery - except successful minor surgery without clinical symptoms (i.e., PFO, PDA), chest pain (angina), previous heart attack, blocked artery, unexplained shortness of breath, congestive heart failure (CHF), history of stroke, transient ischemic attack, carotid artery disease, myocardial ischemia, myocardial infarction, cardiomyopathy, Cardiovascular implantable active medical device (such as pacemaker or automatic defibrillator), Heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia, and/or High blood pressure: systolic greater than140 mmHg or diastolic greater than 90 mmHg on 3 consecutive readings
Participants with self-reported health conditions such as: diabetes, uncontrolled thyroid disease, kidney disease/chronic renal impairment, history of seizures (except childhood febrile seizures), epilepsy, history of unexplained syncope, recent history of frequent migraine headaches, recent symptomatic head injury (within the last 2 months), Cancer requiring chemotherapy, radiation, or currently on treatment, Participants with self-reported known clotting disorders, history of bleeding disorders or personal history of prolonged bleeding from injury, history of blood clots, hemophilia, current use of blood thinner: prescription or daily use of aspirin, and/or Sickle Cell Trait or Disease.
Participants with severe contact allergies to standard adhesives, latex, silicone, or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported) 11. Unwillingness or inability to remove colored nail polish or non-clear artificial nails from test digits 12. Surgical hardware in pathway which would limit the ability to test sites needed for the study 13. Other known health condition, should be considered upon disclosure in health assessment form.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SpO2 Measurements - All Subjects	SpO2 Sensor Testing	Participants participating in this study will be connected to eight (8) Portrait Mobile P-SA01PL/P-SP01PL prototype sensors provided by GEHC and two reference monitors, Nellcor N-600X V 1.6.0.0 and a forehead sensor, used as standard operating procedures at the site. Data will be collected using the Portrait Hub patient monitor. The participants are exposed to a desaturation protocol that sequentially decreases the SpO2 in a stepwise fashion. The goal is to achieve six stable oxygenation plateaus between 100 and 70% SpO2, while recording simultaneous SpO2 readings from the prototype and reference devices. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.

Primary Outcome Measures

Name	Time	Method
Collection of Subject SpO2 Percentage Sensor Data With Transfer Standard Measurements for Validation	2 Weeks	The collection of SpO2 percentage sensor data with simultaneous transfer standard SpO2 percentage measurements (simulating blood sample SpO2) from each subject enrolled in the study.

Secondary Outcome Measures