Accuracy of Pulse Oximeters With Profound Hypoxia
Not Applicable
Recruiting
- Conditions
- Hypoxemia
- Interventions
- Diagnostic Test: Data acquisition using DT-400 pulse oximetry system
- Registration Number
- NCT06022523
- Lead Sponsor
- Consolidated Research, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Exclusion Criteria
Pregnancy -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Acquisition Data acquisition using DT-400 pulse oximetry system Subjects will undergo profound hypoxia with stable plateaus.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Consolidated Research, Inc.
🇺🇸Cleveland, Ohio, United States