Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-13

Study Completion Date

2022-09-13

Brief Summary

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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.

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RECRUITING

Detailed Description

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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.

Conditions

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Hypoxia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective feasibility study,

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Remote Automated Monitoring System

Intervention Type OTHER

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

Interventions

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Remote Automated Monitoring System

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes