Pulse Oximeter Accuracy for Hypoxia

Overseen By Alisa L Niksch

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Owlet Baby Care, Inc.

Disqualifiers: Obesity, Heart disease, Lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 75 minutes

160 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy participants with no medical problems, it's likely that those on regular medications may not qualify.

What data supports the effectiveness of the treatment Owlet OSS 3.0 for hypoxia?

The research suggests that modern pulse oximeters, like the Owlet OSS 3.0, are generally accurate in measuring oxygen levels even in patients with poor blood flow, especially when placed on the earlobe. This indicates that the Owlet OSS 3.0 may be effective in accurately detecting hypoxia (low oxygen levels in the blood). ^{1 2 3 4 5}

Is the Owlet OSS 3.0 pulse oximeter safe for use in humans?

Pulse oximeters, including newer models like the Owlet OSS 3.0, are generally safe for use in humans, but their accuracy can vary based on conditions like skin pigmentation and blood flow. They are more accurate when placed on the earlobe and in patients with good blood flow, but may be less reliable in people with darker skin or poor circulation. ^{1 5 6 7 8}

How does the pulse oximeter treatment for hypoxia differ from other treatments?

The pulse oximeter treatment for hypoxia is unique because it focuses on accurately measuring oxygen levels in the blood, especially during low oxygen conditions, using advanced technology and algorithms. Unlike other treatments that might directly address hypoxia through medication or oxygen therapy, this approach aims to improve the precision of monitoring devices, which is crucial for effective management of the condition. ^{1 2 5 6 9}

What is the purpose of this trial?

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.

Research Team

Koa Gudelunas

Principal Investigator

Vital Signs Research Group

Eligibility Criteria

This trial is for young, healthy adults. Participants must be able to undergo brief periods of reduced oxygen levels and have blood samples taken from their wrist artery. They should also be comfortable with a motion simulator device being applied to their hands.

Inclusion Criteria

I am fluent in English, both in writing and speaking.

I am in good health with no major medical issues.

The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria

The subject has a history of sensitivity to local anesthesia.

The subject has any other condition, which in the opinion of the investigators, would make them unsuitable for the study.

The subject is pregnant, lactating or trying to get pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo standardized plateaus of oxygen desaturation to evaluate the accuracy of the Owlet noninvasive pulse oximeter during motion and nonmotion conditions

75 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Owlet OSS 3.0

Trial Overview The study is testing the accuracy of the Owlet OSS 3.0 pulse oximeter by comparing its readings against arterial blood samples during controlled hypoxia (low oxygen levels) and simulated hand movements in participants.

Participant Groups

Group I: Hypoxia Plateau Protocol Experimental Treatment 1 Intervention

Study participants that all undergo standardized plateaus of oxygen desaturation to evaluate the accuracy of the Owlet noninvasive pulse oximeter during motion and nonmotion conditions.

Who Is Running the Clinical Trial?

Owlet Baby Care, Inc.

Lead Sponsor

Trials

11

Recruited

9,600+

Findings from Research

A systematic review of 22 studies found that 75% of pulse oximeters are accurate in adults with poor peripheral perfusion, particularly newer models that use advanced algorithms.

Oximeters placed on the earlobe showed greater measurement accuracy compared to those placed on the fingertip, highlighting the importance of placement in obtaining reliable readings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of pulse oximeters in measuring oxygen saturation in patients with poor peripheral perfusion: a systematic review. Poorzargar, K., Pham, C., Ariaratnam, J., et al.[2022]

Among three iPhone pulse oximetry applications tested on 191 patients, the iOx app showed the best correlation with standard pulse oximetry, but still misclassified about 24% of patients' hypoxia status.

The other two apps, POx and Ox, demonstrated very poor accuracy in measuring SpO2 and detecting hypoxia, indicating that these applications should not be relied upon for accurate assessments in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of iPhone oximetry apps: A comparison with standard pulse oximetry measurement in the emergency department. Jordan, TB., Meyers, CL., Schrading, WA., et al.[2021]

In a study of 193 ICU patients, four different pulse oximeters were tested against arterial blood gas measurements, revealing significant bias in their SpO2 readings; the Philips oximeter overestimated oxygen saturation while the Nonin, Nellcor, and Masimo oximeters underestimated it.

The ability of these oximeters to detect moderate hypoxemia varied significantly, with the Nonin oximeter detecting hypoxemia in 92% of cases, while the Philips oximeter only detected it in 11%, highlighting potential clinical implications for oxygen therapy management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Multiple Pulse Oximeters in Stable Critically Ill Patients. Blanchet, MA., Mercier, G., Delobel, A., et al.[2023]

In a study of 33 open-heart surgery patients, three different pulse oximeters provided reliable readings of oxygen saturation and heart rate even during low cardiac index and low peripheral temperature conditions.

The accuracy of these oximeters was consistent with normal physiological states, suggesting they can be trusted in critical situations post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of three pulse oximeters at low cardiac index and peripheral temperature. Pälve, H., Vuori, A.[2019]

In a study involving 25 healthy volunteers, the accuracy of four different pulse oximeters decreased significantly as arterial oxygen saturation (SaO2) levels fell below 90%, leading to misleading SpO2 readings that were higher than actual levels.

The findings highlight the importance of using co-oximetry to confirm arterial blood oxyhemoglobin saturation during severe hypoxemia, as pulse oximeters may not provide reliable readings in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of pulse oximetry during hypoxemia. Thrush, D., Hodges, MR.[2022]

In a study using an in vitro circulation system, a benchtop pulse oximeter showed good accuracy in measuring oxygen saturation across various levels of anemia, except at the most severe anemia (10% hematocrit).

The handheld and fingertip pulse oximeters demonstrated decreased accuracy, particularly at lower hematocrit levels, highlighting that severe anemia can significantly affect pulse oximeter performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying pulse oximeter accuracy during hypoxemia and severe anemia using an in vitro circulation system. Gylys, R., Feiner, J., Pologe, J., et al.[2023]

During induced hypoxemia, pulse oximeters were generally accurate when oxygen saturation was high, but they consistently underreported saturation levels when actual values dropped to 75% or lower, highlighting a limitation in their performance under severe conditions.

Among the tested oximeters, the Ohmeda 3740 and Nellcor N200 were the quickest to detect desaturation, while the Novametrix Oxypleth was notably faster in returning to baseline saturation after resaturation with 100% oxygen, indicating variability in response times among different models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse oximeter performance during desaturation and resaturation: a comparison of seven models. Trivedi, NS., Ghouri, AF., Lai, E., et al.[2019]

Pulse oximeters have been found to be less accurate in patients with darker skin, which can lead to missed diagnoses of hypoxemia, highlighting a significant safety concern in their use.

The authors propose five key areas for research and regulatory changes to improve oximeter accuracy, including diversifying study subject pools and enhancing transparency in performance reporting, which could help ensure safer and more effective use of these devices across all skin types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. Okunlola, OE., Lipnick, MS., Batchelder, PB., et al.[2023]

A study tested the accuracy of pulse oximeters from 14 manufacturers on 125 subjects, revealing significant variability in their performance, especially at low oxygen saturation levels (O2Hb).

Most pulse oximeters tended to underestimate oxygen saturation, with some models showing substantial bias and poor precision, indicating that not all devices are equally reliable for monitoring patients with low oxygen levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Errors in 14 pulse oximeters during profound hypoxia. Severinghaus, JW., Naifeh, KH., Koh, SO.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Accuracy of pulse oximeters in measuring oxygen saturation in patients with poor peripheral perfusion: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The utility of iPhone oximetry apps: A comparison with standard pulse oximetry measurement in the emergency department. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Accuracy of Multiple Pulse Oximeters in Stable Critically Ill Patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Accuracy of three pulse oximeters at low cardiac index and peripheral temperature. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Accuracy of pulse oximetry during hypoxemia. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Quantifying pulse oximeter accuracy during hypoxemia and severe anemia using an in vitro circulation system. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Pulse oximeter performance during desaturation and resaturation: a comparison of seven models. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Errors in 14 pulse oximeters during profound hypoxia. [2019]