NightOwl Pulse Oximeter Calibration Study
Not Applicable
- Conditions
- Pulse Oximeter Calibration
- Interventions
- Device: NightOwl
- Registration Number
- NCT03774199
- Lead Sponsor
- Ectosense NV
- Brief Summary
Calibration of a software module that computes SpO2 based on photoplethysmography (PPG) traces acquired by a reflectance-based pulse oximeter which can be placed on the index finger or the forehead.
The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601- 2-61:2011)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- healthy subjects (ASA 1 and ASA 2) upon signing the informed consent. (ASA : american society of anesthesiologist's health score)
Exclusion Criteria
- smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels.
- individuals subject to conditions that result in elevated levels of methaemoglobin.
- individuals with arterial cannulation or hypoxia at FiO2 = 0,21
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pulse oximeter calibration population NightOwl -
- Primary Outcome Measures
Name Time Method A_rms determination Within 3 months after subject recruitment, the calibration and ARMS determination should have been performed. After calibration of the NightOwl SpO2 software module, the A_rms metric will be computed. This metric constitutes the performance metric proposed by ISO 80601-2-61:2011 Annex CC: Determination of accuracy. This metric captures the bias and precision of the computed SpO2 values compared to the benchmark.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CMC
🇧🇪Genk, Limburg, Belgium