Wireless Disposable SpO2 Sensor Hypoxia Testing

NCT06211530 | Completed Results FDA Device

• 1 other identifier: 2023-061-MS-GES
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

SpO2; Peripheral Oxygen Saturation Measurement

Outcome Measures

Primary Outcomes (1)

• Collection of Subject SpO2 Percentage Sensor Data With Transfer Standard Measurements for Validation

  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.

  2 Weeks

Other Outcomes (1)

• Number of Safety Events

  2 Weeks

Study Arms (1)

SpO2 Measurements - All Subjects

EXPERIMENTAL

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.

Device: SpO2 Sensor Testing

Interventions

SpO2 Sensor Testing 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.

SpO2 Measurements - All Subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Element Materials Technology

Louisville, Colorado, 80027, United States

Location

Related Publications (5)

• Foglia EE, Whyte RK, Chaudhary A, Mott A, Chen J, Propert KJ, Schmidt B. The Effect of Skin Pigmentation on the Accuracy of Pulse Oximetry in Infants with Hypoxemia. J Pediatr. 2017 Mar;182:375-377.e2. doi: 10.1016/j.jpeds.2016.11.043. Epub 2016 Dec 9.

  PMID: 27939107 BACKGROUND

• Tin W, Lal M. Principles of pulse oximetry and its clinical application in neonatal medicine. Semin Fetal Neonatal Med. 2015 Jun;20(3):192-7. doi: 10.1016/j.siny.2015.01.006. Epub 2015 Feb 18.

  PMID: 25704605 BACKGROUND

• Gehring H, Duembgen L, Peterlein M, Hagelberg S, Dibbelt L. Hemoximetry as the "gold standard"? Error assessment based on differences among identical blood gas analyzer devices of five manufacturers. Anesth Analg. 2007 Dec;105(6 Suppl):S24-S30. doi: 10.1213/01.ane.0000268713.58174.cc.

  PMID: 18048894 BACKGROUND

• Batchelder PB, Raley DM. Maximizing the laboratory setting for testing devices and understanding statistical output in pulse oximetry. Anesth Analg. 2007 Dec;105(6 Suppl):S85-S94. doi: 10.1213/01.ane.0000268495.35207.ab.

  PMID: 18048904 BACKGROUND

• Fouzas S, Priftis KN, Anthracopoulos MB. Pulse oximetry in pediatric practice. Pediatrics. 2011 Oct;128(4):740-52. doi: 10.1542/peds.2011-0271. Epub 2011 Sep 19.

  PMID: 21930554 BACKGROUND

Related Links

• FDA -- U.S. Food and Drug Administration. Pulse Oximeters -- Premarket Notification Submissions \[510(k)s\] - Guidance for Industry and Food and Drug Administration Staff. March 4, 2013.

Results Point of Contact

• Title: Principal Engineer
• Organization: GE HealthCare

100012917@gehealthcare.com

+358 (40) 7755194

Study Officials

• Monica Rabanal, NP

  Element Materials Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 18, 2024
• Study Start: January 30, 2024
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)