Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers

IHU Strasbourg18 enrolled

Overview

In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 30 healthy volunteers under induced and controlled hypoxia.

The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in real-time, remotely and continuously 11 clinical key-indicators by being attached to the patient thorax: ECG trace, heart rate, oxygen saturation, respiratory rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion index, skin temperature, physical activity and body position. Designed to be worn continuously for at least seven days, the patient can keep the patch during his sleep or in the shower. The aim of this study is to determine the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System under induced hypoxia, in terms of accuracy. The study population includes 30 healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypoxia

Interventions

Remote Automated Monitoring SystemOTHER

The subject will be monitored with conventional monitoring devices as well as the MultiSense patch.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men or women between 18 to 50 years of age. * Subject able to receive and understand information related to the study and give written informed consent. * Subject is a non-smoker or an ex-smoker (stopped smoking for at least 6 months). * Subject demographics include a range of dark skin pigmentations, including at least 30% of the total pool, assessed by phototypes V and VI according to the Fitzpatrick scale (Questionnaire score between 28 and 40). * Subject is healthy (assessed by a physical examination AND normal ECG AND absence of medical treatment except for the birth control pill). * Subject authorizing the treatment of their personal data collected during the study (box checked in the consent form). * Subject affiliated to the French social security system. Exclusion Criteria: * Subject with antecedent of allergies to adhesives or silicone or a skin disease that would preclude the use of an adhesive. * Subject with an implantable device such as a pacemaker. * Pregnant or lactating women (assessed by a negative ß-HCG test). * Subject with a high-altitude stay during the previous 4 weeks (more than 1 week spent over 3,500 meters). * Subject with Raynaud's syndrome. * Subject in exclusion period (determined by a previous or a current study). * Subject under guardianship or trusteeship. * Subject under the protection of justice.

Locations (1)

Clinical Investigation Center & Physiology and Functional Explorations unit at NHC

Strasbourg, France

Outcomes

Primary Outcomes

Determination of the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System, in terms of accuracy.

Accuracy is defined as an average measurement variation less than 3.5% of the mean value to the reference standard. The data for analysis will be equally distributed across the SpO2 range of 70-100%.

Time frame: from patch placement to patch removal, assessed up to 3 hours

Secondary Outcomes

Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions

comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of anion superoxide (µmol/min)

Time frame: from patch placement to patch removal, assessed up to 3 hours

Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions

comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of lipids peroxidation (µg/mL)

Time frame: from patch placement to patch removal, assessed up to 3 hours

Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions

comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of protein carbonylation (ng/mL)

Time frame: from patch placement to patch removal, assessed up to 3 hours

Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions

comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of catalase (U/mg protein)

Data from ClinicalTrials.gov

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