Status:
UNKNOWN
NightOwl Pulse Oximeter Calibration Study
Lead Sponsor:
Ectosense NV
Conditions:
Pulse Oximeter Calibration
Eligibility:
All Genders
13+ years
Phase:
NA
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. ...
Eligibility Criteria
Inclusion
- healthy subjects (ASA 1 and ASA 2) upon signing the informed consent. (ASA : american society of anesthesiologist's health score)
Exclusion
- 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
Key Trial Info
Start Date :
December 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 14 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03774199
Start Date
December 14 2018
End Date
April 14 2020
Last Update
March 21 2019
Active Locations (1)
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1
CMC
Genk, Limburg, Belgium, 3600