Wireless Disposable SpO2 Sensor Hypoxia Testing Part 1, Non-invasive Development Test for the New LED Platform (SpO2 Dispo)

The purpose of the TruSignal sensor LED platform SpO2 sensor accuracy study with human volunteer participants is to collect SpO2 data from P-SA01PL and P-SP01PL prototype sensors and reference data to develop a calibration model for new TruSignal LED platform at different pigmentation values according to the Monk Skin Scale.

Study Overview

• Status: Not yet recruiting
• Conditions: SpO2 \(Peripheral Oxygen Saturation\) Measurement Validation
• Intervention / Treatment: Device: SpO2 Sensor Testing

Detailed Description

The rapid measure of oxygen saturation level using the pulse oximeter is an important vital sign, which is one of the most used monitoring devices in clinics. Blood oxygen levels are indicated as SpO2, showing the percent saturation of oxygen, and it becomes a non-invasive continuous oxygen monitoring for different ages.

GE Healthcare (GEHC) pulse oximetry is a transmissive pulse oximetry where the sensor is placed on a thin part of the patients body, usually a fingertip, where the probe passes two wavelengths of light through the body part to a photodetector. These two wavelengths of light are generated with carefully selected LEDs to maintain clinical accuracy constantly. The principle of pulse oximetry is based on the variation in the ratio of light absorbances. Pulse oximetry technology enables SpO2 with enhanced accuracy, durability, and infection control with single-patient use.

GEs current LED selection is based on early 1990s clinical studies and investigations and it has not been re-assessed ever since due to large dependence with various SpO2 monitoring systems, which requires separate validation in the clinics. In order to reduce component cost profiles and component availability risks, this study aims to select new LEDs for the next generation GE SpO2 probes and sensors. We aim to introduce and develop new SpO2 platforms to improve efficiency of modern LEDs.

The effect of skin pigmentation may affect the accuracy of pulse oximetry measurement. To respond to the recent concern related to effect of skin pigmentation in SpO2 accuracy (and expected changes in SpO2 standard and FDA Pulse Oximetry Guidance), the development data is collected with equal number of participants from light, medium, and darkly pigmented participant subgroups.

Here we will collect SpO2 data with simultaneous transfer standard SpO2 to develop a calibration model for the new LED platform. 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).

Funding for this study will be provided by GE HealthCare (GEHC). The purpose of the TruSignal sensor LED platform SpO2 sensor accuracy study with human volunteer participants is to collect SpO2 data from P-SA01PL and P-SP01PL prototype sensors and reference data to develop a calibration model for new TruSignal LED platform at different pigmentation values according to the Monk Skin Scale.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amie Robinson; Phone Number: 816-719-6765; Email: Amie.Robnison@GeHealthcare.com

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Element Materials Technology
      • Contact: Monica Rabanal, NP, Medical Director; Phone Number: 303-926-5432; Email: Monical.Rabanal@element.com
      • Principal Investigator: Monica Rabanal, NP, Medical Director
      • Sub-Investigator: Rachael Carlotta, LRCP, RRT, VA-BC
      • Sub-Investigator: Tanya Lange, LRCP, RRT, VA-BC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SpO2 Measurements - All Subjects; 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	The primary objective is to collect SpO2 data with simultaneous transfer standard SpO2 measurements (simulating blood sample SpO2).	1 Month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Objective	The safety objective is to collect safety information, including type and number of AEs, SAEs, and device issues.	1 Month

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Monica Rabanal, NP, Element Materials Technology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 29, 2024
• Primary Completion (Estimated): February 10, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 2023-061-MS-GES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No