Validation Study of the EMILY AI Device in Acute and Chronic Respiratory Failure

Not Applicable

Recruiting

• Conditions: Chronic Respiratory Failure; Acute Respiratory Failure

• Registration Number: NCT06952816
• Lead Sponsor: Aether Tech S.L.

Brief Summary

Currently, there is no holistic solution for patients with respiratory diseases that includes oxygenation and management of a patient with respiratory disease, combining dynamic and automatic O2 administration and the detection of clinical worsening, generating a diagnostic suspicion, a management proposal, and notifying the medical team.

For device validation, prospective studies will be conducted in patients in respiratory intermediate care units, conventional hospitalization, during physical activity in the hospital setting, and in an out-of-hospital setting. The device will be evaluated in terms of oxygenation efficacy, response time, patient safety, efficiency, versatility, clinical benefit, and adaptability.

Detailed Description

There is no doubt about the efficacy of oxygen therapy in the treatment of acute and chronic respiratory failure in different clinical settings. However, its therapeutic dosage is not as strict as that of other treatments. Hypoxemia has been associated with increased mortality in multiple pathologies and clinical situations. Furthermore, the liberal use of oxygen therapy has also demonstrated harmful effects. Therefore, titration of this therapy is necessary. Traditionally, this has been performed manually, although in recent years, new devices have been developed to automatically adjust O2 flow rates to the needs of each patient, with the goal of maintaining stable oxygen saturations. These systems have the potential to reduce medical error, improve morbidity and mortality, and reduce care costs.

This study is a clinical investigation using a non-CE marked medical device, prospectively validating the device's functional status. The objective is to evaluate its efficacy and safety in patients with respiratory failure, both in hospital and outpatient settings.

The EMILY system is composed of several components designed to provide the following features:

* Sensors: Sensors currently used for clinical validations in hospitals. The sensors are certified medical grade and are a commercial product. They are the only electrical component in direct contact with the patient. The Emily system is sensor-agnostic. Other non-medical-grade smartwatch-type wearable sensors are used in outpatient applications.

* Emily.AI Smart Valve: This is a new product developed by the company for automatic opening of the O2 valve proportional to the patient's oxygen needs. It connects to the sensors and mobile phone via BLE and/or Wi-Fi.

* EMILY APP: Via the App, this is a commercial product that connects to SmartValve and the sensors via BLE and/or Wi-Fi to obtain data. In addition, the patient will be able to provide information about their clinical situation, obtain information about their disease, receive management recommendations, and act as a communication channel between the patient and the medical team.

* Emily Cloud AI: It will integrate the patient's clinical data, all the data obtained by the sensors, and information provided by the patient through questions in the mobile app. It will detect clinical changes and generate the necessary actions for clinical management and notify the medical team.

* Dashboard where the medical team will monitor all available patient information, visualize clinical changes, and interact if necessary.

Since EMILY covers both the hospital and outpatient settings, it allows for continuous care for chronic patients, creating a bidirectional information loop between the patient and specialized care, continuously and whenever necessary. However, the advantages of this solution go beyond the purely healthcare or treatment setting, as it includes an educational component, prevention, and recommendation of good habits: alerts, with a medication reminder; additional information of interest on publications and studies, industry events, and participation in associations/foundations; and communication, enabling doctor-patient and patient-patient interaction with an alert system, and allowing the participation of patients' families in the care process.

Study Timeline

• Study First Submitted: 2025-04-08
• Study Start: 2025-04-23
• Study First Submitted QC: 2025-04-23
• Status Verified: 2025-05
• Study First Posted: 2025-05-01
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Men and women over 18 years of age.
• Admitted to intermediate respiratory care unit with a diagnosis of acute respiratory failure for at least 8 hours.
• Informed consent understood and signed.

Exclusion Criteria

• Hemodynamic instability.
• Severe temperature changes.
• Hemoglobinopathies, severe anemia, severe acidosis, or severe alkalosis.
• Anatomical disturbances.
• Pregnancy or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
EFFICACY - EVALUATION OF THE RATE THE DEVICE MAINTAINS BLOOD OXYGEN SATURATION LEVELS	From enrollment to the end of treatment at 8 hours.	Evaluation of the rate that the device maintains blood oxygen saturation levels measured by pulse oximetry within predetermined ranges in patients diagnosed with ARF (hypoxemic patients: 94-98%; hypercapnic patients: 92-94%) without providing less or more oxygen than required to keep the patient within the defined range.

Secondary Outcome Measures

Name	Time	Method
ACCURACY - MEASUREMENT OF THE SYSTEM'S ACTION SPEED CORRECTING THE OXYGEN SATURATION LEVELS	From enrollment to the end of treatment at 8 hours.	Calculate the speed of action of the system from 1) detection of saturation out-of-range to the start of correction and 2) until the patient returns to the defined saturation range
ALERT SYSTEM - MEASUREMENT OF THE NUMBER OF SYSTEM ALERTS	From enrollment to the end of treatment at 8 hours.	Measure the number of times EMILY alerts about a change in the oxygen saturation of monitored patients using its alarm system.
ALERT SYSTEM - EVALUATION OF THE AUTHENTICITY OF THE SYSTEM ALERTS BY COMPARING THE OXYGEN SATURATION LEVELS WITH A CONVENTIONAL SYSTEM	From enrollment to the end of treatment at 8 hours.	Evaluate the alarm's authenticity by checking oxygen saturation with a conventional system and, in case of discrepancies, by arterial blood gas analysis.
EFFICIENCY - MEASUREMENT OF THE NUMBER OF TIMES THE MEDICAL AND NURSING TEAM MUST ADJUST THE OXYGENATION	From enrollment to the end of treatment at 8 hours.	Evaluate the need for nursing and medical team intervention, measured by the number of times they must visit to adjust oxygenation or address symptoms related to oxygenation, primarily cardiorespiratory symptoms.
VERSATILITY - COMPARISON OF BLOOD OXYGEN SATURATION LEVELS MAINTENANCE BETWEEN DIFFERENT PROFILES AND SITUATIONS	From enrollment to the end of treatment at 8 hours.	Evaluation of the rate that the device maintains blood oxygen saturation levels in different profiles, such as patients with pure hypoxemia and those with hypercapnia, and in different clinical situations such as bed rest, sitting, eating, or receiving physical therapy. This rate will be compared across these different profiles and situations.

Trial Locations

Locations (1)

Hospital Universitario Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain