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The SATURİSTA Device (SATURİSTA)

4 maj 2026 uppdaterad av: Koç University

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

7

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Real-Time Data Display Performance
Tidsram: 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.
Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Alarm Response Time
Tidsram: Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
Time (in seconds) between a decrease in SpO₂ below the predefined threshold and activation of the system alarm.
Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Display Delay
Tidsram: Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
Time (in seconds) between SpO₂ measurement and visualization on the user interface.
Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
Signal Recovery Performance
Tidsram: Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
Proportion of scenarios in which the system successfully resumes valid data acquisition and terminates alarms after probe reconnection.
Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
Technical Reliability
Tidsram: Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session
Frequency of technical issues or system failures observed during testing sessions.
Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Koç University

Samarbetspartners

Health Institutes of Turkey
Istinye University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 mars 2026

Primärt slutförande (Beräknad)

1 juni 2026

Avslutad studie (Beräknad)

1 december 2026

Studieregistreringsdatum

Först inskickad

24 april 2026

Först inskickad som uppfyllde QC-kriterierna

4 maj 2026

Första postat (Faktisk)

8 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 maj 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 25-134

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

Individual participant data (IPD) sharing has not yet been determined. As this study is a pilot feasibility study involving a small sample of healthy volunteers, no formal data sharing plan has been established at this stage. Data sharing may be considered in future studies following evaluation of study outcomes, ethical considerations, and institutional policies.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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