Pulse Oximeter CalibrationNOSCSNCT04194073
NightOwl SpO2 Calibration Study
A study testing Pulse oximeter calibration population (NightOwl) in people with Pulse Oximeter Calibration, run by Ectosense NV at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulse Oximeter Calibration
- What is being tested?
- Pulse oximeter calibration population (NightOwl)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Dec 2019to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects with American Society of Anaesthesiologists health score (ASA) of 1 or 2, upon signing of informed consent.
- 15% of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study
Who cannot join
- smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhemoglobin levels.
- individuals subject to conditions that result in elevated levels of methaemoglobin.
- individuals with arterial cannulation or hypoxia at FiO2 = 0,21
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CMC
Genk, Limburg, 3600
Raf De Jongh, MD PhD, 0032 / 477 / 514 772, raf.dejongh@skynet.be
About this study
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)
Read the detailed description
- Trial objectives The main objective of this trial is to calibrate the parameters of a software module that computes SpO2 from the digitized raw red and infrared PPG traces of the NightOwl sensor placed at the fingertip. A CO-oximeter subsequently analyses the blood samples to derive "Gold-standard" SaO2 values to which the SpO2 samples can be compared. To obtain a spectrum of SpO2 levels between 100 and 73 % of healthy subjects, FiO2 will be progressively decreased in a hypoxia chamber under the guidance of an anaesthesiologist.
- Endpoints Computation of Arms, 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 gold standard blood gas analysis method. The software modules' SpO2 computation accuracy (defined as Arms) will first be compared using the temporally paired oxygen saturation (SaO2) readings of the CO-oximeter benchmark.
- Trial Design The trial is designed as open blind, non-randomized trial for clinical data acquisition. Approximately 10 healthy subjects will be included in the study.
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.
- Conditions
- Pulse Oximeter Calibration
- Being tested
- Pulse oximeter calibration population (NightOwl)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeter calibration population (NightOwl)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Pulse oximeter calibration population | Experimental | All subjects within this single arm of the study will undergo the calibration experiment as described in the Detailed Description Receives: Device: Pulse oximeter calibration population (NightOwl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months after subject recruitment, the calibration and A_rms determination should have been performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start7 Dec 2019
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse Oximeter CalibrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ectosense NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raf De Jongh, MD PhD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194073
- Sponsor's protocol ID
- 19/0073/U
- Acronym
- NOSCS
- Status last verified
- Dec 2019
- First submitted
- 7 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NightOwl SpO2 Calibration Study
- ClinicalTrials.gov ID
- NCT04194073
- Acronym / sponsor ID
- NOSCS / 19/0073/U
- Conditions
- Pulse Oximeter Calibration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ectosense NVIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
- Trial objectives The main objective of this trial is to calibrate the parameters of a software module that computes SpO2 from the digitized raw red and infrared PPG traces of the NightOwl sensor placed at the fingertip. A CO-oximeter subsequently analyses the blood samples to derive "Gold-standard" SaO2 values to which the SpO2 samples can be compared. To obtain a spectrum of SpO2 levels between 100 and 73 % of healthy subjects, FiO2 will be progressively decreased in a hypoxia chamber under the guidance of an anaesthesiologist.
- Endpoints Computation of Arms, 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 gold standard blood gas analysis method. The software modules' SpO2 computation accuracy (defined as Arms) will first be compared using the temporally paired oxygen saturation (SaO2) readings of the CO-oximeter benchmark.
- Trial Design The trial is designed as open blind, non-randomized trial for clinical data acquisition. Approximately 10 healthy subjects will be included in the study.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse oximeter calibration population | Experimental | Device: Pulse oximeter calibration population (NightOwl)All subjects within this single arm of the study will undergo the calibration experiment as described in the Detailed Description |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subjects with American Society of Anaesthesiologists health score (ASA) of 1 or 2, upon signing of informed consent.
- 15% of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study
Key exclusion criteria (3 listed)
- smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhemoglobin levels.
- individuals subject to conditions that result in elevated levels of methaemoglobin.
- individuals with arterial cannulation or hypoxia at FiO2 = 0,21
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Pulse oximeter calibration population |
Primary outcome
A_rms determination
Time frame: Within 3 months after subject recruitment, the calibration and A_rms 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raf De Jongh, MD PhD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse oximeter calibration population (NightOwl) in people with Pulse Oximeter Calibration, run by Ectosense NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederik Massie, MSc (0032474942710, frederik.massie@ectosense.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A_rms determination (time frame: Within 3 months after subject recruitment, the calibration and A_rms determination should have been performed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.