Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers (HYPO)

Evaluation of RDS MultiSense® in Desaturation Analysis and Effects of Hypoxia on Circulating Oxidative Stress and Mitochondrial Respiration in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Other: Remote Automated Monitoring System

Detailed Description

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
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • Clinical Investigation Center & Physiology and Functional Explorations unit at NHC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Automated Monitoring System; Two MultiSense® patches will be placed on each volunteer. The monitoring will last no more than 3 hours, during an induced and controlled hypoxia.	Other: Remote Automated Monitoring System; The subject will be monitored with conventional monitoring devices as well as the MultiSense patch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	from patch placement to patch removal, assessed up to 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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 superoxide dismutase (U/mg protein)	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 glutathione (µmol/g protein)	from patch placement to patch removal, assessed up to 3 hours
Comparison of Mitochondrial respiration from PBMCs between hypoxia and normal oxygenation conditions.	Mitochondrial respiration from PBMCs is assessed by high-resolution respirometry by analysis of the kinetic of the respirometry results and comparison between each hypoxia /post-hypoxia data point with the baseline.	from patch placement to patch removal, assessed up to 3 hours
To evaluate the impact of skin pigmentation on SpO2 determination by the MultiSense® solution.	Comparison of the MultiSense® SpO2 performances with the reference between light and dark-pigmented subjects. Qualitative comparison of the raw PPG signal between light and dark-pigmented skin subjects.	from patch placement to patch removal, assessed up to 3 hours
To evaluate pulse transit time (PTT) as an indicator of blood pressure (BP) variation.	Comparison of blood pressure variation measured by a standard cuff device with PTT variation measured by the MultiSense® acquisition system.	from patch placement to patch removal, assessed up to 3 hours
To evaluate the reliability of the respiration rate determined by the MultiSense® solution	Determination of the quality of respiration rate provided by the MultiSense® patch in comparison to measurements made with reference medical devices in the hospital setting, in terms of accuracy. Accuracy is defined as an average measurement variation less than 5% of the respiration rate mean value to the reference standard.	from patch placement to patch removal, assessed up to 3 hours
To compare the quality of MultiSense® data from a patch worn on the chest and from a patch worn on the upper back in different body posture and to evaluate the impact of strip exact localization on the chest.	Qualitative comparison of the raw PPG signal between the two patches location for each subject (chest and back). Comparison of the SpO2 derived by each MultiSense® patch to the reference during the resting period in different lying positions (supine, prone, left and right side).	from patch placement to patch removal, assessed up to 3 hours

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Collaborators: Rhythm Diagnostic Systems
• Investigators: Principal Investigator: Bernard Geny, Pr, Physiology and Functional Exploration, NHC Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: hypoxia; non-invasive blood pressure; SpO2; vital signs; real-time monitoring; cardio-respiratory monitoring; connected device
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 21-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No