Wireless Disposable SpO2 Sensor Hypoxia Testing

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-30

Study Completion Date

2024-02-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SpO2 System Accuracy Testing With Different Sensors

NCT01613222

Pulse Oximetry

COMPLETED NA

The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus

NCT06516809

Healthy

COMPLETED

RDS MultiSense® SpO2 Validation Study

NCT05359328

Hypoxia

COMPLETED NA

A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunteers

NCT05895682

Oxygen Saturation

COMPLETED NA

Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings

NCT04233827

Pulse Oximetry

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SpO2 Peripheral Oxygen Saturation Measurement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SpO2 Measurements - All Subjects

Participants participating in this study will be connected to sensors. The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.

Group Type EXPERIMENTAL

SpO2 Sensor Testing

Intervention Type DEVICE

Participants participating in this study will be connected sensors.The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SpO2 Sensor Testing

Participants participating in this study will be connected sensors.The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Participant is considered as being morbidly obese (defined as BMI greater than 39.5)
2. 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).
3. Tattoo in the optical path which would limit the ability to test sites needed for the study.
4. 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
5. 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.
6. 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).
7. 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
8. 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.

10\. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes