Accuracy of Pulse Oximeters With Profound Hypoxia

Consolidated Research, Inc.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Hypoxemia

Interventions

Data acquisition using DT-400 pulse oximetry systemDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \- Exclusion Criteria: Pregnancy -

Locations (1)

Consolidated Research, Inc.

Cleveland, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Saturation level measurement

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

Time frame: Within 12 months of subject recruitment

Data from ClinicalTrials.gov

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