Accuracy of Pulse Oximeters With Profound Hypoxia

Accuracy of Pulse Oximeters With Profound Hypoxia - Test Protocol

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05322382

Enrollment

Registered

2022-04-11

Start date

2021-06-02

Completion date

2021-06-03

Last updated

2022-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SpO2

Brief summary

This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017).

Detailed description

After local anesthetic injection, a 22-gauge catheter is inserted in one radial artery. Pulse oximeters are attached to fingers, ears, or flat body surfaces. Subjects are in a comfortable semi-recumbent position. Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. Stable, safe, and controlled hypoxia is breath-by-breath by breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of saturation.

Interventions

PROCEDUREA-line

Subjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. The subject is male or female, aged ≥18 and \<50. 2. The subject is in good general health with no evidence of any medical problems. 3. The subject is fluent in both written and spoken English. 4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion criteria

1. The subject is obese (BMI\>30). 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. Subject has diabetes. 5. Subject has a clotting disorder.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of pulse oximeter with profound hypoxia	2 days	Perform accurate measurement of a range of arterial HbO2 saturation from 100 to down to 70% during mild, moderate, and severe hypoxia.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026