Clinical trial NCT06952816: Validation Study of the EMILY AI Device in Acute and Chronic Respiratory Failure
Official title: Functional, Clinical, and Predictive Validation Study of the EMILY AI Device in Patients With Acute and Chronic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Respiratory Failure
Acute Respiratory Failure
Keywords: Respiratory failure
Hypoxia
Hyperxia
Oxigenotherapy
Lead sponsor: Aether Tech S.L.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario Fundación Jiménez Díaz
name: Hospital Clinic of Barcelona
First posted: 2025-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: EFFICACY - EVALUATION OF THE RATE THE DEVICE MAINTAINS BLOOD OXYGEN SATURATION LEVELS
timeFrame: From enrollment to the end of treatment at 8 hours.
Secondary outcomes:
measure: ACCURACY - MEASUREMENT OF THE SYSTEM'S ACTION SPEED CORRECTING THE OXYGEN SATURATION LEVELS
timeFrame: From enrollment to the end of treatment at 8 hours.
measure: ALERT SYSTEM - MEASUREMENT OF THE NUMBER OF SYSTEM ALERTS
timeFrame: From enrollment to the end of treatment at 8 hours.
measure: ALERT SYSTEM - EVALUATION OF THE AUTHENTICITY OF THE SYSTEM ALERTS BY COMPARING THE OXYGEN SATURATION LEVELS WITH A CONVENTIONAL SYSTEM
timeFrame: From enrollment to the end of treatment at 8 hours.
measure: EFFICIENCY - MEASUREMENT OF THE NUMBER OF TIMES THE MEDICAL AND NURSING TEAM MUST ADJUST THE OXYGENATION
timeFrame: From enrollment to the end of treatment at 8 hours.
measure: VERSATILITY - COMPARISON OF BLOOD OXYGEN SATURATION LEVELS MAINTENANCE BETWEEN DIFFERENT PROFILES AND SITUATIONS
timeFrame: From enrollment to the end of treatment at 8 hours.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
Study officials:
References: