Healthy
Conditions
Brief summary
The purpose of the study is to test the performance and safety of the Bioserenity pulse oxymeter EOXY. For that, and in agreement with ISO60601-2-61 norm and FDA regulation, measures of heart rate, with a gold-standard, and SaO2 measures generated by blood samples will be compared with Sp02 and heart rate measures that are generated by our EOXY. Thirteen healthy subjects will participate in the study in total. Three subjects will be enrolled during a primary phase .They will participate at a secondary phase as well as ten others subjects. The purpose of the primary phase is to test the body area where the measurement can be done. The purpose of the secondary phase is to measure SpO2 and HR in desaturation conditions.
Detailed description
The primary objective is to evaluate and document the SpO2 accuracy of the pulse oximeter equipment, evaluating the performance of the device compared to invasive method blood sampling (SaO2) by CO-Oximeter in healthy subjects during invasive controlled desaturation study at different ranges (100 % to 70% SaO2). Subject safety during desaturation and saturation period, will be evaluated by reviewing vital sign: heart rate (HR) continuously and blood pressure/temperature between each desaturation plateau. There are two secondaries objectives, the measurement of the variation of the fraction of inspired oxygen (FiO2), and the validation of the algorithm for data review and analysis. For the study primary phase, the purpose of this phase is to test the body area where the SpO2 is better detected and define 3 measurement areas. For this, three healthy volunteers will be placed in normal O2 saturation, the SpO2 will be measured using the Bioserenity oximeter (noninvasive method) and will be compared to a gold-standard oximeter CE-marked. The investigator will determine the best area in the body where the SpO2 could be taken for the following subjects. During a second phase, the measurement of Sp02 and HR with EOXY, will be performed in O2 saturation conditions up to 100% and then in desaturation by plateau from 100 % to 70%. 3 EOXY pulse oximeter recorded the SpO2 at the same time in 3 different areas of the body. As required by the standard, Sp02 measures will be simultaneously compared to SaO2 values measured by blood sampling taken from an indwelling arterial catheter. The HR obtained with EOXY will be compared simultaneously to a gold standard oximeter CE-marked. As the example in the standard, it was choosen to do the test on the 70-100% range, with 5 plateaus (100%-97%, 97%-92%, 92%-85%, 84%-78%, 77%-70%) and to collect five Sp02 and Sa02 values (blood samples) and five HR measures, per plateau, for each of 13 subjects. The desaturation will be controlled thanks' the FiO2 measures, that should allow to bring subjects near target levels of desaturation plateau.
Interventions
DEVICEEOXY device
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
DEVICEGold standard oximeter
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
PROCEDURESaO2 sampling
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Sponsors
NAMSA
Université Catholique de Louvain
BioSerenity
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
No randomisation. All subjects will test simultaneously the gold standard and the EOXY device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy subject (Man/ Women) \> 18 years old * Subject signed informed consent prior to any screening procedure * Subject in good health (COHb \< 3% , MetHb \< 2%, CtHb \> 10mg/dL) * Healthy adult capable of undergoing controlled hypoxemia to the level called for in the protocol with minimal medical risk
Exclusion criteria
* Smokers or individuals exposed to high levels of carbon monoxide that result in elevation of carboxy hemoglobin levels * Individual subject to conditions that result in elevated levels of methemoglobin * Subject who would be placed at undue medical risk associated with any procedure called for in the protocol * Subject with open wounds * Pregnant woman (negative pregnancy test needed) * Subject allergic to silicon, polyamide and silver yarn * Subject with cardiorespiratory disorders likely to worsen with thoracic pressure applied by the textile band * Subject with mental or motor impairment preventing him from expressing pain * Subject with blood or skin disorder that may impacting results * Subject with behavioral disorders, too agitated or too aggressive * Subject with sensorial disorders, insensible to skin pain * Subject susceptible to tension/pressure based headaches
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position | 1 day | For each desaturation plateau, SpO2 ARMS are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements |
| Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position | 1 day | For each desaturation plateau, SpO2 ARMS (Accuracy Root-Mean Square) are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements |
| Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position | 1 day | For each desaturation plateau, SpO2 ARMS are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements |
| HR Accuracy Root-Mean Square (ARMS) at Forehead Position | 1 day | For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements |
| Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position | 1 day | For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements |
| Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position | 1 day | For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EOXY Device and Gold Standard Oximeter and SaO2 Measures Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter
EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | EOXY Device and Gold Standard Oximeter and SaO2 Measures |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 23.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment Belgium | 10 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
HR Accuracy Root-Mean Square (ARMS) at Forehead Position
For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements
Time frame: 1 day
Population: People respecting study conditions (good irrigation and no movements)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | HR Accuracy Root-Mean Square (ARMS) at Forehead Position | Overall range 70-100% of O2 | 12.2 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | HR Accuracy Root-Mean Square (ARMS) at Forehead Position | 97-100% of O2 | 10.0 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | HR Accuracy Root-Mean Square (ARMS) at Forehead Position | 97-92% of O2 | 11.7 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | HR Accuracy Root-Mean Square (ARMS) at Forehead Position | 92-85% of O2 | 11.5 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | HR Accuracy Root-Mean Square (ARMS) at Forehead Position | 84-78% of O2 | 14.3 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | HR Accuracy Root-Mean Square (ARMS) at Forehead Position | 77-70% of O2 | 13.0 percentage of ARMS (accuracy) |
Primary
Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position
For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements
Time frame: 1 day
Population: People respecting study conditions (good irrigation and no movements)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position | Overall range 70-100% of O2 | 21.1 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position | 97-100% of O2 | 22.3 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position | 97-92% of O2 | 24.6 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position | 92-85% of O2 | 19.2 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position | 84-78% of O2 | 19.1 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position | 77-70% of O2 | 20.6 percentage of ARMS (accuracy) |
Primary
Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position
For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements
Time frame: 1 day
Population: People respecting study conditions (good irrigation, no movements)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position | 84-78% of O2 | 30.4 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position | 77-70% of O2 | 36.5 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position | Overall range 70-100% of O2 | 32.1 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position | 97-100% of O2 | 30.8 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position | 97-92% of O2 | 31.5 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position | 92-85% of O2 | 31.5 percentage of ARMS (accuracy) |
Primary
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position
For each desaturation plateau, SpO2 ARMS are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position | Overall range 70-100% of O2 | 6.02 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position | 97-100% of O2 | 7.09 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position | 97-92% of O2 | 6.63 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position | 92-85% of O2 | 6.57 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position | 84-78% of O2 | 5.06 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position | 77-70% of O2 | 3.96 percentage of ARMS (accuracy) |
Primary
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position
For each desaturation plateau, SpO2 ARMS are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements
Time frame: 1 day
Population: Subjects respecting the study conditions (no movements, good irrigation) 3 subjects excluded from analysis(no respect of study conditions) so 10 subjects analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position | Overall range 70-100% of O2 | 3.91 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position | 97-100% of O2 | 3.08 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position | 92-85% of O2 | 2.85 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position | 84-78% of O2 | 3.48 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position | 77-70% of O2 | 6.21 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position | 97-92% of O2 | 3.36 percentage of ARMS (accuracy) |
Primary
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position
For each desaturation plateau, SpO2 ARMS (Accuracy Root-Mean Square) are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements
Time frame: 1 day
Population: Subjects respecting the study conditions (no movements, good irrigation) 3 subjects excluded from analysis(no respect of study conditions) so 10 subjects analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position | 92-85% of O2 | 9.91 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position | 84-78% of O2 | 7.31 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position | Overall range 70-100% of O2 | 11.14 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position | 97-100% of O2 | 12.99 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position | 97-92% of O2 | 12.51 percentage of ARMS (accuracy) |
| EOXY Device and Gold Standard Oximeter and SaO2 Measures | Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position | 77-70% of O2 | 10.76 percentage of ARMS (accuracy) |