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Accuracy of Pulse Oximeters During Profound Hypoxia (APO)

Primary Purpose

Hypoxia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Arterial blood draw
Oxygen reduction
Sponsored by
Philips Clinical & Medical Affairs Global
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypoxia focused on measuring SpO2, photoplethysmography, camera based photoplethysmography

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hypoxia Centre of the Complementary Medical Centre (CMC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

NI(Fast-Sitting)

NI(Slow-Sitting)

NI(Fast-Lying)

IN(Fast-Sitting)

Arm Description

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.

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%

Volunteers included in the Non-Invasive (Fast-Lying) group follow the NI (Rapid-sitting) protocol although in lying position.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Plateau 1
Bias and 95% limits of agreement (LOA) of TDw1 SpO2 - Nellcor SpO2 in 90-100% Nellcor SpO2 range
Plateau 2
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 80-90% Nellcor SpO2 range
Plateau 3
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 70-80% Nellcor SpO2 range
Plateau 4
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 70-100% Nellcor SpO2 range
Statistics pooled subjects
Bland-Altman of pooled subjects' TDw1 SpO2 - Nellcor SpO2
Statistics individual subject
Bland-Altman of Bias for each individual subject
Statistics individual subject 2
Line listing for each individual subject

Full Information

First Posted
February 10, 2023
Last Updated
March 16, 2023
Sponsor
Philips Clinical & Medical Affairs Global
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1. Study Identification

Unique Protocol Identification Number
NCT05790616
Brief Title
Accuracy of Pulse Oximeters During Profound Hypoxia
Acronym
APO
Official Title
Accuracy of Pulse Oximeters During Profound Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
SpO2, photoplethysmography, camera based photoplethysmography

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NI(Fast-Sitting)
Arm Type
Experimental
Arm Description
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.
Arm Title
NI(Slow-Sitting)
Arm Type
Experimental
Arm Description
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%
Arm Title
NI(Fast-Lying)
Arm Type
Experimental
Arm Description
Volunteers included in the Non-Invasive (Fast-Lying) group follow the NI (Rapid-sitting) protocol although in lying position.
Arm Title
IN(Fast-Sitting)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arterial blood draw
Intervention Description
For the IN(Fast-Sitting) arm arterial blood will be collected to derive "Gold-standard" SaO2 reference values.
Intervention Type
Other
Intervention Name(s)
Oxygen reduction
Intervention Description
Volunteers undergo an ambient oxygen decrease from 21% to 10%
Primary Outcome Measure Information:
Title
Algorithm validation
Description
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).
Time Frame
90 minutes per test per participant
Secondary Outcome Measure Information:
Title
Plateau 1
Description
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
Title
Plateau 2
Description
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 80-90% Nellcor SpO2 range
Time Frame
90 minutes per test per participant
Title
Plateau 3
Description
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 70-80% Nellcor SpO2 range
Time Frame
90 minutes per test per participant
Title
Plateau 4
Description
Bias and 95% LOA of TDw1 SpO2 - Nellcor SpO2 in 70-100% Nellcor SpO2 range
Time Frame
90 minutes per test per participant
Title
Statistics pooled subjects
Description
Bland-Altman of pooled subjects' TDw1 SpO2 - Nellcor SpO2
Time Frame
90 minutes per test per participant
Title
Statistics individual subject
Description
Bland-Altman of Bias for each individual subject
Time Frame
90 minutes per test per participant
Title
Statistics individual subject 2
Description
Line listing for each individual subject
Time Frame
90 minutes per test per participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daphne van Scheppingen
Phone
+316 3857 3076
Email
daphne.van.scheppingen@philips.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raf De Jongh, MD
Organizational Affiliation
Hypoxia Centre of the Complementary Medical Centre (CMC) Genk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hypoxia Centre of the Complementary Medical Centre (CMC)
City
Genk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raf De Jongh

12. IPD Sharing Statement

Plan to Share IPD
No

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Accuracy of Pulse Oximeters During Profound Hypoxia

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