Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer

• Sponsor: BioSerenity (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03614416
• Collaborator: NAMSA (Other), Université Catholique de Louvain (Other)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: EOXY device; Device: Gold standard oximeter; Procedure: SaO2 sampling	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: No randomisation. All subjects will test simultaneously the gold standard and the EOXY deviceNo randomisation. All subjects will test simultaneously the gold standard and the EOXY device
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer
• Actual Study Start Date: Dec 8, 2017
• Actual Primary Completion Date: Dec 15, 2017
• Actual Study Completion Date: Nov 6, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: EOXY device and Gold standard oximter 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

Device: EOXY device; Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard; Device: 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; Procedure: SaO2 sampling; Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Université catholique louvain la neuve, centre sportif	Louvain-la-Neuve		Belgium	1348

Sponsors and Collaborators

• BioSerenity
• NAMSA
• Université Catholique de Louvain

Investigators

• Principal Investigator: marc FRANCAUX, UNIVERSITE CATHOLIQUE DE LOUVAIN

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 5, 2017

More Information

Publications

None provided.

• Responsible Party: BioSerenity
• ClinicalTrials.gov Identifier: NCT03614416
• Other Study ID Numbers: BIOSERENITY_80601-2-61
• First Posted: Aug 3, 2018
• Last Update Posted: Jan 12, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	EOXY Device and Gold Standard Oximeter and SaO2 Measures
Arm/Group Description	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
Period Title: Overall Study
STARTED	13
COMPLETED	13
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	EOXY Device and Gold Standard Oximeter and SaO2 Measures
Arm/Group Description	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
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	23.5
Sex: Female, Male (Count of Participants)
Female	3 30%
Male	7 70%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 20%
White	6 60%
More than one race	2 20%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Belgium	10 100%

Outcome Measures

1. Primary Outcome

Title	Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position
Description	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

Outcome Measure Data

Analysis Population Description

Subjects respecting the study conditions (no movements, good irrigation) 3 subjects excluded from analysis(no respect of study conditions) so 10 subjects analyzed

Arm/Group Title	EOXY Device and Gold Standard Oximeter and SaO2 Measures
Arm/Group Description	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
Measure Participants	10
Overall range 70-100% of O2	3.91
97-100% of O2	3.08
97-92% of O2	3.36
92-85% of O2	2.85
84-78% of O2	3.48
77-70% of O2	6.21

2. Primary Outcome

Title	Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position
Description	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

Outcome Measure Data

Analysis Population Description

Subjects respecting the study conditions (no movements, good irrigation) 3 subjects excluded from analysis(no respect of study conditions) so 10 subjects analyzed

Arm/Group Title	EOXY Device and Gold Standard Oximter and SaO2 Measures
Arm/Group Description	SPO2 measures provided from EOXY device 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 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard Gold standard oximeter: Sp02 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard SaO2 sampling: Sp02 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Measure Participants	10
Overall range 70-100% of O2	11.14
97-100% of O2	12.99
97-92% of O2	12.51
92-85% of O2	9.91
84-78% of O2	7.31
77-70% of O2	10.76

3. Primary Outcome

Title	Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EOXY Device and Gold Standard Oximeter and SaO2 Measures
Arm/Group Description	SPO2 measures provided from EOXY device 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 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard Gold standard oximeter: Sp02 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard SaO2 sampling: Sp02 measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Measure Participants	10
Overall range 70-100% of O2	6.02
97-100% of O2	7.09
97-92% of O2	6.63
92-85% of O2	6.57
84-78% of O2	5.06
77-70% of O2	3.96

4. Primary Outcome

Title	HR Accuracy Root-Mean Square (ARMS) at Forehead Position
Description	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

Outcome Measure Data

Analysis Population Description

People respecting study conditions (good irrigation and no movements)

Arm/Group Title	EOXY Device and Gold Standard Oximeter and SaO2 Measures
Arm/Group Description	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
Measure Participants	10
Overall range 70-100% of O2	12.2
97-100% of O2	10.0
97-92% of O2	11.7
92-85% of O2	11.5
84-78% of O2	14.3
77-70% of O2	13.0

5. Primary Outcome

Title	Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position
Description	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

Outcome Measure Data

Analysis Population Description

People respecting study conditions (good irrigation, no movements)

Arm/Group Title	EOXY Device and Gold Standard Oximeter and SaO2 Measures
Arm/Group Description	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
Measure Participants	10
Overall range 70-100% of O2	32.1
97-100% of O2	30.8
97-92% of O2	31.5
92-85% of O2	31.5
84-78% of O2	30.4
77-70% of O2	36.5

6. Primary Outcome

Title	Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position
Description	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

Outcome Measure Data

Analysis Population Description

People respecting study conditions (good irrigation and no movements)

Arm/Group Title	EOXY Device and Gold Standard Oximeter and SaO2 Measures
Arm/Group Description	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
Measure Participants	10
Overall range 70-100% of O2	21.1
97-100% of O2	22.3
97-92% of O2	24.6
92-85% of O2	19.2
84-78% of O2	19.1
77-70% of O2	20.6

Adverse Events

Time Frame	2 days for each subject (days of participation)
Arm/Group Title	EOXY Device and Gold Standard Oximeter and SaO2 Measures
Arm/Group Description	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
All Cause Mortality
	EOXY Device and Gold Standard Oximeter and SaO2 Measures
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	EOXY Device and Gold Standard Oximeter and SaO2 Measures
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	EOXY Device and Gold Standard Oximeter and SaO2 Measures
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.