Accuracy of Pulse Oximeters With Profound Hypoxia

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06022523

Enrollment

Registered

2023-09-05

Start date

2022-11-09

Completion date

2024-11-09

Last updated

2023-09-05

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

Conditions

Hypoxemia

Keywords

Hypoxia, Pulse oximetry

Brief summary

The goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. The study is designed in accordance with ISO 80601- 2-61,2ed:2017-12 & 2018-02.

Interventions

DIAGNOSTIC_TESTData acquisition using DT-400 pulse oximetry system

Acquisition of photopleth data during profound hypoxia using a Consolidated Research DT-400 pulse oximetry system.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Exclusion criteria

Pregnancy -

Design outcomes

Primary

Measure	Time frame	Description
Saturation level measurement	Within 12 months of subject recruitment	Induction of hypoxia by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide to allow measurement of oxyhemoglobin saturation between 70-100%. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable

Countries

United States

Outcome results

None listed

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