An interventional study of Arterial blood draw and Oxygen reduction in Hypoxia, sponsored by Philips Clinical & Medical Affairs Global. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Philips Clinical & Medical Affairs Global · Not applicable, Interventional, and Screening
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:
During the study the following devices will be additionally used by the volunteers:
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):
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.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's planned enrollment of 66 is above the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Philips Clinical & Medical Affairs Global is the lead sponsor of 82 studies on the registry; 24 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Oxygen reduction
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%
Other: Oxygen reduction
Volunteers included in the Non-Invasive (Fast-Lying) group follow the NI (Rapid-sitting) protocol although in lying position.
Other: Oxygen reduction
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.
Procedure: Arterial blood draw · Other: Oxygen reduction
For the IN(Fast-Sitting) arm arterial blood will be collected to derive "Gold-standard" SaO2 reference values.
Volunteers undergo an ambient oxygen decrease from 21% to 10%
Algorithm validation
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).
Time frame: 90 minutes per test per participant
Plateau 1
Bias and 95% limits of agreement (LOA) of TDw1 SpO2 - Nellcor SpO2 in 90-100% Nellcor SpO2 range
Time frame: 90 minutes per test per participant
Plateau 2
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 80-90% Nellcor SpO2 range
Time frame: 90 minutes per test per participant
Plateau 3
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 70-80% Nellcor SpO2 range
Time frame: 90 minutes per test per participant
Plateau 4
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 70-100% Nellcor SpO2 range
Time frame: 90 minutes per test per participant
Statistics pooled subjects
Bland-Altman of pooled subjects' TDw1 SpO2 - Nellcor SpO2
Time frame: 90 minutes per test per participant
Statistics individual subject
Bland-Altman of Bias for each individual subject
Time frame: 90 minutes per test per participant
Statistics individual subject 2
Line listing for each individual subject
Time frame: 90 minutes per test per participant
Plan to share: No
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Philips Clinical & Medical Affairs Global