The SATURİSTA Device

NCT07576946 | Active Not Recruiting

• 1 other identifier: 25-134
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Therapy

Keywords

oxygen therapy; artifical-intelligence; medical device; nursing care; patient safety; sustainability

Outcome Measures

Primary Outcomes (1)

• Real-Time Data Display Performance

  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

Secondary Outcomes (1)

• Alarm Response Time

  Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session

Other Outcomes (3)

• Display Delay

  Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session

• Signal Recovery Performance

  Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session

• Technical Reliability

  Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead
• Health Institutes of Turkey: collaborator
• Istinye University: collaborator

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 27483512 BACKGROUND

• 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.

  PMID: 30587955 BACKGROUND

• 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.

  PMID: 41605593 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 8, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

TU (1)