An interventional study of Pulse oximeter calibration population (NightOwl) in Pulse Oximeter Calibration, sponsored by Ectosense NV. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-11.
Sponsored by Ectosense NV (part of ResMed) · Not applicable, Interventional, and Basic science
Calibration of a software module that computes Oxygen saturation(SpO2) based on photoplethysmography (PPG) traces acquired by the NightOwl reflectance-based PPG sensor which is placed on the finger.
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)
Groups of up to 3 subjects will enter a hypoxia chamber. These subjects will have six NightOwl sensors attached, one placed on the index, middle, and ring finger of each hand. For each patient, one Nonin pulse oximeter with a real time SpO2 display will be placed on the pinkie, such that the SpO2 values can be monitored in real time. The NightOwl will transfer data to a smartphone, which serves as a data acquisition hub during the study. Once all sensors have been attached and data acquisition has started, FiO2 (percentage of oxygen in the space being measured) of the hypoxia chamber will gradually and be lowered over a course of approximately 2 hours, under the guidance of an anaesthesiologist. The investigators will attempt to create 5 stable plateaus of FiO2 values to allow for arterial blood sample drawing of a stable SaO2 value. As soon as SpO2 measured by a Nonin device of any subject drops below 73% for one minute, this particular subject will leave the hypoxia chamber immediately. As soon as all subjects have left the chamber, FiO2 will be returned to the oxygen level of the environment. The above is repeated for the next group of subjects until the warranted number of subjects is reached. During the procedure, for each subject, approximately 25 arterial blood samples will be drawn from an arterial catheter, of which the exact time of extraction will be noted.
Ectosense NV is the lead sponsor of 6 studies on the registry; none are open to participants now.
First submitted before Ectosense NV became part of ResMed.
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Exclusion Criteria:
individuals with arterial cannulation or hypoxia at FiO2 = 0,21
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects within this single arm of the study will undergo the calibration experiment as described in the Detailed Description
Device: 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
A_rms determination
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.
Time frame: Within 3 months after subject recruitment, the calibration and A_rms determination should have been performed
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2019 (actual). Primary completion is estimated for Jan 2020, 1 month after the start.
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This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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