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

BioSerenity

Status: Completed

Conditions: Healthy

Treatments: Device: EOXY device; Device: Gold standard oximeter; Procedure: SaO2 sampling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03614416

BIOSERENITY_80601-2-61

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

EOXY device and Gold standard oximter and SaO2 measures

Experimental 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

Treatment:

Procedure: SaO2 sampling

Device: Gold standard oximeter

Device: EOXY device