Clinical trial NCT06850610: Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus
Official title: Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxia
Keywords: hypoxia
pulse oximeter
accuracy
Owlet
Lead sponsor: Owlet Baby Care, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study tests the accuracy of pulse oximeters in a range of arterial oxygen levels from 100% down to 70%. This is done by comparing the test pulse oximeter readings of young, healthy, adult study participants with blood samples drawn from an artery in the wrist during brief plateaus of progressively lower oxygen saturations. The arterial blood sample is processed in a device called a multi-wavelength hemoximeter and compared to the simultaneous oximeter reading. During each set level of oxygen the participant may be asked to have a motion simulator device apply different types of movement to their hands to assess the pulse oximeter's accuracy during motion. This study will be evaluating the Owlet OSS 3.0 sensor, a component in 2 FDA cleared noninvasive pulse oximeters indicated for infants 1-18 months of age.

Testing should require approximately an hour and 15 minutes of the participant's time.

Detailed description: Several separate cohorts of study participants will be recruited and enrolled in accordance with laboratory time and staff availability. After informed consent is performed, a local anesthetic will be injected around the radial artery, and a 22-gauge radial artery catheter will be placed. Pulse oximeters/sensors under test will be attached to the subject along with FDA-cleared reference pulse oximeters. ECG electrodes will be placed on the subject to monitor the subject's heart rate. The Owlet Sensor under test placement and serial numbers will be documented for each subject. Subjects will be placed in a seated, semi-reclined position. Subjects will breathe a nitrogen-air-carbon dioxide mixture to produce the desired level of hypoxemia.

Each subject will undergo two cycles of three different hypoxia plateaus in the 90-100%, 80-90% and 70-80% range, with an average of 20-24 data pairs with a maximum range of 17-30 data points. Study subjects may be have a motion protocol applied to test the Owlet Sensor's accuracy during variable frequencies and amplitudes of movement.

The motions applied by the motion simulator will be 1) 2 Hz sine 10mm 2) 3 Hz sine 10mm 3) 4 Hz sine 10mm 4 ) Random motion 30mm peak, 20 to 200 mm / sec These motions are applied with the fingers tapping on the first cycle of hypoxia and rubbing on the second cycle. The subject will not perform the motion during the first blood sample of each plateau but will during the 2-4th samples separated by 30 seconds.

90% of participants will have at least one usable data point below 85% and at least 69% of subjects will have one usable data pair between 70-80%. As this procedure is evaluating a single user device, a new sensor will be applied to each study participant.

The skin tone distribution of subjects will be divided into 3 groups based on the 10 point Monk skin tone scale (MST) and Individual Typology Angle (ITA) measured by an ISO compliant colorimeter at the forehead and at the anatomic location of sensor placement. MST will be assessed with a printed color swatch that has been verified by a colorimeter. Enrollment of subjects must follow these criteria:

* At least 25% of subjects will be Monk Skin Tone (MST) 1-4 with an ITA greater than 30
* At least 25% of subjects will be MST 5-7 and have an ITA between -30 and 30
* At least 25%-of subjects will be MST 8-10 with an ITA less than -30 (with one half of MST 8-10 subjects having an ITA of less than -50)

Eligibility criteria: Inclusion Criteria:

1. The subject is in good general health with no evidence of any medical problems.
2. The subject is fluent in both written and spoken English.
3. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject is obese (BMI\>35).
2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
3. Diagnosis of asthma, sleep apnea, or use of CPAP.
4. The subject has diabetes.
5. The subject has a clotting disorder.
6. The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
7. The subject has any other serious systemic illness.
8. The subject has a carboxyhemoglobin level greater than 3% (determined during the first sample)
9. Any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigators' would interfere with the sensors working correctly.
10. The subject has a history of fainting or vasovagal response.
11. The subject has a history of sensitivity to local anesthesia.
12. The subject has a diagnosis of Raynaud's disease.
13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
14. The subject is pregnant, lactating or trying to get pregnant.
15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Primary outcomes:
measure: Pulse Oximeter Accuracy Measures
timeFrame: From enrollment to completion of 6 plateaus of hypoxia over an approximate 75 minute period.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Vital Signs Research Group
state: California
Study officials:
affiliation: Vital Signs Research Group
name: Koa Gudelunas
role: STUDY_DIRECTOR
References:
citation: Cohen PR, DiMarco MA, Geller RL, Darrisaw LA. Colorimetric Scale for Skin of Color: A Practical Classification Scale for the Clinical Assessment, Dermatology Management, and Forensic Evaluation of Individuals With Skin of Color. Cureus. 2023 Nov 1;15(11):e48132. doi: 10.7759/cureus.48132. eCollection 2023 Nov.
citation: Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pigmentation on pulse oximeter accuracy at low saturation. Anesthesiology. 2005 Apr;102(4):715-9. doi: 10.1097/00000542-200504000-00004.
citation: Okunlola OE, Lipnick MS, Batchelder PB, Bernstein M, Feiner JR, Bickler PE. Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. Respir Care. 2022 Feb;67(2):252-257. doi: 10.4187/respcare.09795. Epub 2021 Nov 12.
citation: Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2020 Dec 17;383(25):2477-2478. doi: 10.1056/NEJMc2029240. No abstract available.