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The SATURİSTA Device (SATURİSTA)

4 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

7

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Real-Time Data Display Performance
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Alarm Response Time
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Display Delay
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Koç University

Collaborateurs

Health Institutes of Turkey
Istinye University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 mars 2026

Achèvement primaire (Estimé)

1 juin 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

24 avril 2026

Première soumission répondant aux critères de contrôle qualité

4 mai 2026

Première publication (Réel)

8 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 25-134

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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