This study aims to evaluate the functional performance and feasibility of the Saturista system, a novel device designed for automated oxygen flow regulation based on continuous monitoring of oxygen saturation (SpO₂). The system integrates real-time physiological monitoring, wireless data transmission, and centralized visualization to support timely detection of oxygen desaturation and clinical decision-making.
A pilot feasibility study will be conducted in healthy volunteers using a scenario-based protocol, including baseline monitoring, controlled desaturation, probe disconnection, and signal recovery. The primary objective is to assess the system's ability to generate alarms in response to changes in SpO₂ and to display data in real time. Secondary objectives include evaluation of response time, signal management, and overall system stability.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Healthy adult volunteers aged 18 years or older
* Resting oxygen saturation (SpO₂) within the normal range at baseline
* Ability to understand the study procedures and provide written informed consent
* Willingness to participate in all planned testing scenarios
Exclusion Criteria:
* History of chronic respiratory disease, including asthma, chronic obstructive pulmonary disease, or interstitial lung disease
* Known cardiovascular disease or any condition that may affect oxygen saturation or hemodynamic stability
* Current respiratory symptoms, acute infection, or fever at the time of participation
* Anemia, peripheral circulatory disorders, or any condition that may interfere with pulse oximetry measurements
* Skin lesions, deformity, or injury at the intended probe placement site
* Pregnancy
* History of syncope, intolerance to short-duration breath-holding, or any condition that may increase risk during testing
* Inability or unwillingness to comply with study procedures
Primary outcome measure(s)
Real-Time Data Display Performance — Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session Proportion of measurements successfully displayed on the user interface in real time during all testing scenarios.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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