Trials / Completed
CompletedNCT05044585
Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers
Evaluation of RDS MultiSense® in Desaturation Analysis and Effects of Hypoxia on Circulating Oxidative Stress and Mitochondrial Respiration in Healthy Volunteers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- IHU Strasbourg · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Remote Automated Monitoring System | The subject will be monitored with conventional monitoring devices as well as the MultiSense patch. |
Timeline
- Start date
- 2021-09-13
- Primary completion
- 2022-09-13
- Completion
- 2022-09-13
- First posted
- 2021-09-16
- Last updated
- 2023-02-28
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05044585. Inclusion in this directory is not an endorsement.