Accuracy of Pulse Oximeters During Profound Hypoxia

Hypoxia Clinical Trial

— APO  

Official title:

Accuracy of Pulse Oximeters During Profound Hypoxia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05790616
• Other study ID #: ITS_002
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: March 2023
• Source: Philips Clinical & Medical Affairs Global
• Contact: Daphne van Scheppingen
• Phone: +316 3857 3076
• Email: daphne.van.scheppingen[@]philips.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Hypoxia

Intervention

Procedure:
• Arterial blood draw
For the IN(Fast-Sitting) arm arterial blood will be collected to derive "Gold-standard" SaO2 reference values.

Other:
• Oxygen reduction
Volunteers undergo an ambient oxygen decrease from 21% to 10%

Locations

Country	Name	City	State
Belgium	Hypoxia Centre of the Complementary Medical Centre (CMC)	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	90 minutes per test per participant
Secondary	Plateau 1	Bias and 95% limits of agreement (LOA) of TDw1 SpO2 - Nellcor SpO2 in 90-100% Nellcor SpO2 range	90 minutes per test per participant
Secondary	Plateau 2	Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 80-90% Nellcor SpO2 range	90 minutes per test per participant
Secondary	Plateau 3	Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 70-80% Nellcor SpO2 range	90 minutes per test per participant
Secondary	Plateau 4	Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 70-100% Nellcor SpO2 range	90 minutes per test per participant
Secondary	Statistics pooled subjects	Bland-Altman of pooled subjects' TDw1 SpO2 - Nellcor SpO2	90 minutes per test per participant
Secondary	Statistics individual subject	Bland-Altman of Bias for each individual subject	90 minutes per test per participant
Secondary	Statistics individual subject 2	Line listing for each individual subject	90 minutes per test per participant