Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-12-14
2020-04-14
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Pulse oximeter calibration population
NightOwl
The NightOwl is a finger and/or forehead mounted device with, among other functions, the capability to acquire double-wavelength PPG, from which SpO2 can be derived
Interventions
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NightOwl
The NightOwl is a finger and/or forehead mounted device with, among other functions, the capability to acquire double-wavelength PPG, from which SpO2 can be derived
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* individuals subject to conditions that result in elevated levels of methaemoglobin.
* individuals with arterial cannulation or hypoxia at FiO2 = 0,21
13 Years
ALL
Yes
Sponsors
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Ectosense NV
INDUSTRY
Responsible Party
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Locations
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CMC
Genk, Limburg, Belgium
Countries
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Central Contacts
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Facility Contacts
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Rafael De Jongh, MD PhD
Role: primary
Other Identifiers
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17-023U1.1
Identifier Type: -
Identifier Source: org_study_id
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