HypoxiaAPONCT05790616
Accuracy of Pulse Oximeters During Profound Hypoxia
A study testing Arterial blood draw and Oxygen reduction in people with Hypoxia, run by Philips Clinical & Medical Affairs Global at 1 site in Belgium.
Trial summary
This study is designed to calibrate and determine the accuracy for SpO2, pulse rate and respiratory rate of the newly in-house build Test Device wrist 1 (TDw1, or EVA) at Philips. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Arterial blood draw and Oxygen reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Jan 2023to 1 Nov 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects (ASA 1 and ASA 2) between 18 and 65 years of age upon signing the informed consent. (ASA: American Society of Anesthesiologist's health score). In each group, at least 30% of one gender need to be present, and at least 15% of participants have a Fitzpatrick's skin color scale of 5 or 6.
Who cannot join
- Heavy 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 methemoglobin.
- Individuals with low SpO2 or SaO2 (<95%) at FiO2 = 0,21
- Moderate to severe claustrophobia for small rooms
- Severe obesity (BMI > 35 kg/m2)
- Hemoglobinopathies
Show all 10Show fewer
- Arteriopathies, including Raynaud disease
- ASA 3 to 5 subjects
- Tattoo's, skin lesions,use of skin lotions or use of nail polish/fake nails at the region of interest for TDw and TDc
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hypoxia Centre of the Complementary Medical Centre (CMC)
Genk
Raf De Jongh
About this study
This study is designed to calibrate and determine the accuracy for SpO2, pulse rate and respiratory rate of the newly in-house build Test Device wrist 1 (TDw1, or EVA) at Philips.
SpO2, pulse rate and respiratory rate during hypoxia will be calculated by using data of well-known reference devices, including:
Read more
- A reference SpO2 sensor of Nellcor placed at a fingertip, that reflects also continuously the pulse rate Will be used to compare with the test device.
- A reference respiratory rate device that calculates the respiratory rate based on detection of end-tidal CO2 peaks by capnography.
- Oxygen saturation in arterial blood samples (SaO2), determined by a co-oximeter will be used to calculate the accuracy of the test device.
During the study the following devices will be additionally used by the volunteers:
- AppleWatch 7
- TDw2, watch build by philips, using the PPG and software technology developed by Philips
- A smartphone that detects reflected PPG signals from the reflected screen at the handpalm, by the build in frontfacing camera (TDc) of the smartphone
Volunteers will undergo progressive hypoxia (9 min/% O2) from 21 to 10% O2 in an altitude room, resulting in a volunteer's SpO2 of 73%. During this deliberated hypoxia, the volunteers wear the test and reference devices.
This study consists of 4 sub-studies (NI = non-invasive; IN = invasive with an arterial line):
- NI (Fast-Sitting): volunteers are seated in the hypoxia room in which the ambient oxygen concentration decreases at a speed of 9 min/% O2. If the volunteer reached a SpO2 ≤73% for more than 1 minute, he/she leaves the hypoxia room. And will breath air with 21% oxygen. Volunteers wear TDw1 and TDw2 and the reference devices.
- NI(Fast-Lying): identical to NI(Fast-Sitting) but volunteers lay on a mattress. Volunteers wear TDw1 and AppleWatch 7 and the reference devices.
- NI (Slow-Sitting): identical to NI (Fast-Sitting), but after one of the volunteers reaches a SpO2 ≤73% for more than one minute, oxygen in the room increases at a speed of 9 min/% O2 until normal ambient air oxygen concentration of 21%. Volunteers wear TDw1 and AppleWatch 7 and the reference devices.
- IN(Fast-Sitting): identical to NI(Fast-Sitting) but the volunteer's oxygen saturation in blood samples withdrawn via an arterial line is measured in the laboratory.
The NI studies include 18 healthy participants in each sub-study. After the first volunteers have completed the study, small adaptations in the software of the study devices is still possible, e.g. to increase the quality of the PPG-signals. After the three sub-studies are completed, the algorithm for conversion of raw PPG signals to SpO2, pulse rate and respiratory rate will be defined and fixed for the test devices.
During the IN-study, which can only be started after completion of all NI studies, an arterial catheter will be inserted in the radial artery of the 12 participating volunteers, in order to take several blood samples to measure oxygen saturation in the blood (25 samples at well-defined moments during the study per volunteer). Using these results of arterial oxygen saturation, the accuracy of the test devices can be calculated.
- Conditions
- Hypoxia
- Being tested
- Arterial blood draw, Oxygen reduction
- Keywords
- SpO2, photoplethysmography, camera based photoplethysmography
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial blood drawProcedure or surgery
For the IN(Fast-Sitting) arm arterial blood will be collected to derive "Gold-standard" SaO2 reference values.
Oxygen reductionOther
Volunteers undergo an ambient oxygen decrease from 21% to 10%
| Study group | Role | What they receive |
|---|---|---|
| NI(Fast-Sitting) | Experimental | Subgroup Non-Invasive (Fast-Sitting): sitting volunteers undergo an ambient oxygen decrease from 21% to 10% (SpO2 <73% for 1 minute) followed by a fast increase of ambient oxygen concentration.
Fast: if the study is completed for a volunteer reaching SpO2 ≤73%, the subject leaves the room and breaths 21% oxygen. The hypoxia inducing device is stopped after all subjects left the hypoxia room and the door of the hypoxia room is opened, allowing air with 21% O2 to enter the room. Airco fan stays running. Receives: Other: Oxygen reduction |
| NI(Slow-Sitting) | Experimental | Volunteers of subgroup Non-Invasive (Slow-Sitting) follow the NI (Rapid-Sitting) protocol, but after hypoxia at FiO2=0,10 oxygen normalization is programmed to increase at the same speed as the hypoxia creation.
Slow: after target hypoxia has been reached, air with 21% of oxygen is allowed to enter the room in such a way that the speed of increase of O2 to 21% is approximately equal to the decrease of the room's oxygen to 10% Receives: Other: Oxygen reduction |
| NI(Fast-Lying) | Experimental | Volunteers included in the Non-Invasive (Fast-Lying) group follow the NI (Rapid-sitting) protocol although in lying position. Receives: Other: Oxygen reduction |
| IN(Fast-Sitting) | Experimental | After full completion of the Non-Invasive (NI) studies, and a defined algorithm to compute SpO2 by TDw1 is achieved, the study is repeated as described for the NI (Rapid-Sitting) protocol, but arterial blood oxygen saturation (SaO2) will be determined during 5 stable ambient oxygen plateaus (the Invasive (Fast-Sitting) study). These results are used as benchmark to define the final accuracy of TDw1 for SpO2 reproduction. In this part of the study, according to the minimal requirements of the regulatory agencies, 12 volunteers that successfully completed the study will be included. Receives: Procedure: Arterial blood draw; Other: Oxygen reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm validation
- the calculation and validation of the algorithm for
- conversion of the modulation ratio R of theraw PPG signals to SpO2 for all wrist Test Devices.
- conversion of PPG signals to PR and RR.
- determining the accuracy of TDw1 and TDc with cooximetry as golden benchmark in the IN study.
- Looking for the feasibility of TDw2 for further development
The accuracy is represented by A(rms), and specifically for the NI study, the SpO2 range is continuous (SpO2 100- 73%, about 16 000 samples per volunteer). During the IN study the accuracy is represented by A(rms) and calculated for SpO2 versus Sa O2 (about 20 to 25 samples per volunteer).
Measured: 90 minutes per test per participant
Secondary outcomes (7)
Plateau 1
Bias and 95% limits of agreement (LOA) of TDw1 SpO2 - Nellcor SpO2 in 90-100% Nellcor SpO2 range
Measured: 90 minutes per test per participant
Plateau 2
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 80-90% Nellcor SpO2 range
Measured: 90 minutes per test per participant
Plateau 3
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 70-80% Nellcor SpO2 range
Measured: 90 minutes per test per participant
Plateau 4
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 70-100% Nellcor SpO2 range
Measured: 90 minutes per test per participant
Statistics pooled subjects
Bland-Altman of pooled subjects' TDw1 SpO2 - Nellcor SpO2
Measured: 90 minutes per test per participant
Statistics individual subject
Bland-Altman of Bias for each individual subject
Measured: 90 minutes per test per participant
Statistics individual subject 2
Line listing for each individual subject
Measured: 90 minutes per test per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start28 Jan 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raf De Jongh, MD, Principal investigator, Hypoxia Centre of the Complementary Medical Centre (CMC) Genk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790616
- Sponsor's protocol ID
- ITS_002
- Acronym
- APO
- Status last verified
- Mar 2023
- First submitted
- 10 Feb 2023
- Last updated
- 30 Mar 2023
- 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 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pulse Oximeters During Profound Hypoxia
- ClinicalTrials.gov ID
- NCT05790616
- Acronym / sponsor ID
- APO / ITS_002
- Conditions
- Hypoxia
- Keywords
- SpO2, photoplethysmography, camera based photoplethysmography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 30 Mar 2023 (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.
This study is designed to calibrate and determine the accuracy for SpO2, pulse rate and respiratory rate of the newly in-house build Test Device wrist 1 (TDw1, or EVA) at Philips.
SpO2, pulse rate and respiratory rate during hypoxia will be calculated by using data of well-known reference devices, including:
- A reference SpO2 sensor of Nellcor placed at a fingertip, that reflects also continuously the pulse rate Will be used to compare with the test device.
- A reference respiratory rate device that calculates the respiratory rate based on detection of end-tidal CO2 peaks by capnography.
- Oxygen saturation in arterial blood samples (SaO2), determined by a co-oximeter will be used to calculate the accuracy of the test device.
During the study the following devices will be additionally used by the volunteers:
- AppleWatch 7
- TDw2, watch build by philips, using the PPG and software technology developed by Philips
- A smartphone that detects reflected PPG signals from the reflected screen at the handpalm, by the build in frontfacing camera (TDc) of the smartphone
Volunteers will undergo progressive hypoxia (9 min/% O2) from 21 to 10% O2 in an altitude room, resulting in a volunteer's SpO2 of 73%. During this deliberated hypoxia, the volunteers wear the test and reference devices.
This study consists of 4 sub-studies (NI = non-invasive; IN = invasive with an arterial line):
- NI (Fast-Sitting): volunteers are seated in the hypoxia room in which the ambient oxygen concentration decreases at a speed of 9 min/% O2. If the volunteer reached a SpO2 ≤73% for more than 1 minute, he/she leaves the hypoxia room. And will breath air with 21% oxygen. Volunteers wear TDw1 and TDw2 and the reference devices.
- NI(Fast-Lying): identical to NI(Fast-Sitting) but volunteers lay on a mattress. Volunteers wear TDw1 and AppleWatch 7 and the reference devices.
- NI (Slow-Sitting): identical to NI (Fast-Sitting), but after one of the volunteers reaches a SpO2 ≤73% for more than one minute, oxygen in the room increases at a speed of 9 min/% O2 until normal ambient air oxygen concentration of 21%. Volunteers wear TDw1 and AppleWatch 7 and the reference devices.
- IN(Fast-Sitting): identical to NI(Fast-Sitting) but the volunteer's oxygen saturation in blood samples withdrawn via an arterial line is measured in the laboratory.
The NI studies include 18 healthy participants in each sub-study. After the first volunteers have completed the study, small adaptations in the software of the study devices is still possible, e.g. to increase the quality of the PPG-signals. After the three sub-studies are completed, the algorithm for conversion of raw PPG signals to SpO2, pulse rate and respiratory rate will be defined and fixed for the test devices.
During the IN-study, which can only be started after completion of all NI studies, an arterial catheter will be inserted in the radial artery of the 12 participating volunteers, in order to take several blood samples to measure oxygen saturation in the blood (25 samples at well-defined moments during the study per volunteer). Using these results of arterial oxygen saturation, the accuracy of the test devices can be calculated.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NI(Fast-Sitting) | Experimental | Other: Oxygen reductionSubgroup Non-Invasive (Fast-Sitting): sitting volunteers undergo an ambient oxygen decrease from 21% to 10% (SpO2 <73% for 1 minute) followed by a fast increase of ambient oxygen concentration. Fast: if the study is completed for a volunteer reaching SpO2 ≤73%, the subject leaves the room and breaths 21% oxygen. The hypoxia inducing device is stopped after all subjects left the hypoxia room and the door of the hypoxia room is opened, allowing air with 21% O2 to enter the room. Airco fan stays running. |
| NI(Slow-Sitting) | Experimental | Other: Oxygen reductionVolunteers of subgroup Non-Invasive (Slow-Sitting) follow the NI (Rapid-Sitting) protocol, but after hypoxia at FiO2=0,10 oxygen normalization is programmed to increase at the same speed as the hypoxia creation. Slow: after target hypoxia has been reached, air with 21% of oxygen is allowed to enter the room in such a way that the speed of increase of O2 to 21% is approximately equal to the decrease of the room's oxygen to 10% |
| NI(Fast-Lying) | Experimental | Other: Oxygen reductionVolunteers included in the Non-Invasive (Fast-Lying) group follow the NI (Rapid-sitting) protocol although in lying position. |
| IN(Fast-Sitting) | Experimental | Procedure: Arterial blood draw, Other: Oxygen reductionAfter full completion of the Non-Invasive (NI) studies, and a defined algorithm to compute SpO2 by TDw1 is achieved, the study is repeated as described for the NI (Rapid-Sitting) protocol, but arterial blood oxygen saturation (SaO2) will be determined during 5 stable ambient oxygen plateaus (the Invasive (Fast-Sitting) study). These results are used as benchmark to define the final accuracy of TDw1 for SpO2 reproduction. In this part of the study, according to the minimal requirements of the regulatory agencies, 12 volunteers that successfully completed the study will be included. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects (ASA 1 and ASA 2) between 18 and 65 years of age upon signing the informed consent. (ASA: American Society of Anesthesiologist's health score). In each group, at least 30% of one gender need to be present, and at least 15% of participants have a Fitzpatrick's skin color scale of 5 or 6.
Key exclusion criteria (10 listed)
- Heavy 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 methemoglobin.
- Individuals with low SpO2 or SaO2 (<95%) at FiO2 = 0,21
- Moderate to severe claustrophobia for small rooms
- Severe obesity (BMI > 35 kg/m2)
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 |
|---|---|---|
| Arterial blood drawFor the IN(Fast-Sitting) arm arterial blood will be collected to derive "Gold-standard" SaO2 reference values. | Procedure or surgery | IN(Fast-Sitting) |
| Oxygen reductionVolunteers undergo an ambient oxygen decrease from 21% to 10% | Other | IN(Fast-Sitting), NI(Fast-Lying), NI(Fast-Sitting), NI(Slow-Sitting) |
Primary outcome
Algorithm validation
Time frame: 90 minutes per test per participant
1. the calculation and validation of the algorithm for 1. conversion of the modulation ratio R of theraw PPG signals to SpO2 for all wrist Test Devices. 2. conversion of PPG signals to PR and RR. 2. determining the accuracy of TDw1 and TDc with cooximetry as golden benchmark in the IN study. 3. Looking for the feasibility of TDw2 for further development The accuracy is represented by A(rms), and specifically for the NI study, the SpO2 range is continuous (SpO2 100- 73%, about 16 000 samples per volunteer). During the IN study the accuracy is represented by A(rms) and calculated for SpO2 versus Sa O2 (about 20 to 25 samples per volunteer).
7 secondary outcomes
Plateau 1
Time frame: 90 minutes per test per participant
Plateau 2
Time frame: 90 minutes per test per participant
Plateau 3
Time frame: 90 minutes per test per participant
Plateau 4
Time frame: 90 minutes per test per participant
Statistics pooled subjects
Time frame: 90 minutes per test per participant
Statistics individual subject
Time frame: 90 minutes per test per participant
Statistics individual subject 2
Time frame: 90 minutes per test per participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- 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 principal investigator
Hypoxia Centre of the Complementary Medical Centre (CMC) Genk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial blood draw and Oxygen reduction in people with Hypoxia, run by Philips Clinical & Medical Affairs Global 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 1 inclusion and 10 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 30 Mar 2023. 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 Daphne van Scheppingen (+316 3857 3076, daphne.van.scheppingen@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algorithm validation (time frame: 90 minutes per test per participant). 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 30 Mar 2023.