The SATURİSTA Device (SATURİSTA)
Development and Pilot Evaluation of an Artificial Intelligence-Assisted System for Automated Oxygen Flow Regulation: The Saturista Device
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
The findings of this study are expected to provide preliminary evidence regarding the feasibility and functional performance of the Saturista system and to inform the design of future clinical studies in patient populations.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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Istanbul, Turecko (Türkiye)
- Istinye University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
The study population consists of healthy adult volunteers recruited for a pilot feasibility evaluation of the Saturista system. Participants are individuals without known respiratory or cardiovascular disease and with normal baseline oxygen saturation levels.
The purpose of selecting a healthy population is to assess the technical performance and functional reliability of the system under controlled conditions before clinical testing in patient populations. All participants will undergo a structured, scenario-based testing protocol, including baseline monitoring, controlled desaturation maneuvers within safe physiological limits, probe disconnection, and signal recovery.
This population allows for standardized assessment of the system's ability to monitor SpO₂, generate alarms, display real-time data, and manage signal-related events without the confounding effects of underlying clinical conditions.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Healthy Adult Volunteers (Pilot Feasibility Cohort)
This cohort includes healthy adult volunteers participating in a pilot feasibility study to evaluate the functional performance of the Saturista system. Participants will undergo a structured, scenario-based testing protocol under controlled conditions. The protocol includes baseline monitoring, controlled desaturation through short-duration breathing maneuvers, probe disconnection, and signal recovery. The purpose of this cohort is to assess the system's ability to monitor oxygen saturation (SpO₂), generate alarms in response to predefined threshold changes, display data in real time, and manage signal interruption and recovery. No therapeutic intervention is applied, and all procedures are conducted within safe physiological limits under supervision. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Real-Time Data Display Performance
Časové okno: Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
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Proportion of measurements successfully displayed on the user interface in real time during all testing scenarios.
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Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Alarm Response Time
Časové okno: Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
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Time (in seconds) between a decrease in SpO₂ below the predefined threshold and activation of the system alarm.
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Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Display Delay
Časové okno: Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
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Time (in seconds) between SpO₂ measurement and visualization on the user interface.
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Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
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Signal Recovery Performance
Časové okno: Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
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Proportion of scenarios in which the system successfully resumes valid data acquisition and terminates alarms after probe reconnection.
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Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
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Technical Reliability
Časové okno: Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
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Frequency of technical issues or system failures observed during testing sessions.
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Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic(R) during admission with exacerbation of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 14;13:3997-4003. doi: 10.2147/COPD.S183762. eCollection 2018.
- McMullan J, Hart KW, Barczak C, Lindsell CJ, Branson R. Supplemental Oxygen Requirements of Critically Injured Adults: An Observational Trial. Mil Med. 2016 Aug;181(8):767-72. doi: 10.7205/MILMED-D-15-00356.
- Douin DJ, Rice JD, Xiao M, Beaty L, Guo C, Withers C, Sullivan A, Anderson EL, Cheng AC, Banasiewicz MK, Semler MW, Lloyd BD, Maiga A, Gibbs KW, Stettler GR, Khan A, Sally MB, Wright FL, Aggarwal N, Bebarta VS, Ginde AA; SAVE-O2 AI Investigators. Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol. BMJ Open. 2026 Jan 28;16(1):e110739. doi: 10.1136/bmjopen-2025-110739.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 25-134
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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