Clinical trial NCT05044585: Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers
Official title: Evaluation of RDS MultiSense® in Desaturation Analysis and Effects of Hypoxia on Circulating Oxidative Stress and Mitochondrial Respiration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Keywords: vital signs
connected device
real-time monitoring
hypoxia
SpO2
non-invasive blood pressure
cardio-respiratory monitoring
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
Collaborators: name: Rhythm Diagnostic Systems
First posted: 2021-09-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective feasibility study,
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: from patch placement to patch removal, assessed up to 3 hours
Secondary outcomes:
measure: Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
timeFrame: from patch placement to patch removal, assessed up to 3 hours
measure: Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
timeFrame: from patch placement to patch removal, assessed up to 3 hours
measure: Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
timeFrame: from patch placement to patch removal, assessed up to 3 hours
measure: Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
timeFrame: from patch placement to patch removal, assessed up to 3 hours
measure: Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
timeFrame: from patch placement to patch removal, assessed up to 3 hours
measure: Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
timeFrame: from patch placement to patch removal, assessed up to 3 hours
measure: Comparison of Mitochondrial respiration from PBMCs between hypoxia and normal oxygenation conditions.
timeFrame: from patch placement to patch removal, assessed up to 3 hours
measure: To evaluate the impact of skin pigmentation on SpO2 determination by the MultiSense® solution.
timeFrame: from patch placement to patch removal, assessed up to 3 hours
measure: To evaluate pulse transit time (PTT) as an indicator of blood pressure (BP) variation.
timeFrame: from patch placement to patch removal, assessed up to 3 hours
measure: To evaluate the reliability of the respiration rate determined by the MultiSense® solution
timeFrame: from patch placement to patch removal, assessed up to 3 hours
measure: 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.
timeFrame: from patch placement to patch removal, assessed up to 3 hours
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Clinical Investigation Center & Physiology and Functional Explorations unit at NHC
Study officials:
affiliation: Physiology and Functional Exploration, NHC Strasbourg, France
name: Bernard Geny, Pr
role: PRINCIPAL_INVESTIGATOR
References: