Development and Pilot Evaluation of an Artificial Intelligence-Assisted System for Automated Oxygen Flow Regulation: The Saturista Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 7
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
The Saturista system is a novel, integrated platform designed to support automated oxygen therapy management through continuous monitoring of oxygen saturation (SpO₂) and real-time decision support. The system combines pulse oximetry-based sensing, wireless data transmission, a cloud-based data infrastructure, and a web-based user interface within a distributed closed-loop control architecture.
In conventional clinical practice, oxygen therapy is typically adjusted manually based on intermittent assessment of oxygen saturation. This approach may delay recognition of physiological deterioration and timely intervention. The Saturista system addresses this limitation by enabling continuous monitoring, automated alarm generation, and centralized visualization of patient data at the nursing station.
The system consists of three main components: (i) a pulse oximetry-based monitoring module, (ii) an embedded device with wireless communication capabilities that regulates oxygen flow via a pneumatic valve mechanism, and (iii) a cloud-based software platform that processes physiological data and provides real-time visualization and alarm management.
This study is designed as a pilot feasibility study conducted in healthy volunteers to evaluate the technical and functional performance of the system. A scenario-based testing protocol will be applied, including baseline monitoring, controlled desaturation through short-duration breathing maneuvers, probe disconnection, and signal recovery. These scenarios simulate common clinical monitoring conditions and allow assessment of system responsiveness and reliability.
The primary outcome measures include the system's ability to detect decreases in SpO₂ and generate appropriate alarms, as well as its capacity to display physiological data in real time. Secondary outcomes include system response time, detection of signal loss, recovery performance, and overall operational stability.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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