Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

The SATURİSTA Device (SATURİSTA)

4. mai 2026 oppdatert 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

7

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Real-Time Data Display Performance
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Alarm Response Time
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Display Delay
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Koç University

Samarbeidspartnere

Health Institutes of Turkey
Istinye University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. mars 2026

Primær fullføring (Antatt)

1. juni 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

24. april 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

8. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 25-134

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere