An interventional study of Remote Automated Monitoring System in Hypoxia, sponsored by IHU Strasbourg. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by IHU Strasbourg · Not applicable, Interventional, and Other
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.
1,246 studies on the registry are indexed under Hypoxia; 239 are open to participants now.
This study's enrollment of 18 is below the median of 45 across 864 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →IHU Strasbourg is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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.
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
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)
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 superoxide dismutase (U/mg protein)
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 glutathione (µmol/g protein)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: from patch placement to patch removal, assessed up to 3 hours
Plan to share: No
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