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

Functional, Clinical, and Predictive Validation Study of the EMILY AI Device in Patients With Acute and Chronic Respiratory Failure

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Respiratory Failure; Acute Respiratory Failure
• Intervention / Treatment: Device: Emily.AI

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz
    • Contact: Sarah Beatrice Heili Frades Zimmermann MD, PhD; Phone Number: +34 915 50 48 00; Email: SHeili@fjd.es
    • Contact: Alba Naya Prieto, MD; Phone Number: +34 915 50 48 00; Email: alba.naya@fjd.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with respiratory failure; Patients with respiratory failure who meet the inclusion criteria and none of the exclusion criteria.	Device: Emily.AI; EMILY.AI is composed of an O2 regulating valve together with an intelligent system which allows the automation in the regulation of O2 and its customization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EFFICACY - EVALUATION OF THE RATE THE DEVICE MAINTAINS BLOOD OXYGEN SATURATION LEVELS	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.	From enrollment to the end of treatment at 8 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACCURACY - MEASUREMENT OF THE SYSTEM'S ACTION SPEED CORRECTING THE OXYGEN SATURATION LEVELS	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	From enrollment to the end of treatment at 8 hours.
ALERT SYSTEM - MEASUREMENT OF THE NUMBER OF SYSTEM ALERTS	Measure the number of times EMILY alerts about a change in the oxygen saturation of monitored patients using its alarm system.	From enrollment to the end of treatment at 8 hours.
ALERT SYSTEM - EVALUATION OF THE AUTHENTICITY OF THE SYSTEM ALERTS BY COMPARING THE OXYGEN SATURATION LEVELS WITH A CONVENTIONAL SYSTEM	Evaluate the alarm's authenticity by checking oxygen saturation with a conventional system and, in case of discrepancies, by arterial blood gas analysis.	From enrollment to the end of treatment at 8 hours.
EFFICIENCY - MEASUREMENT OF THE NUMBER OF TIMES THE MEDICAL AND NURSING TEAM MUST ADJUST THE OXYGENATION	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.	From enrollment to the end of treatment at 8 hours.
VERSATILITY - COMPARISON OF BLOOD OXYGEN SATURATION LEVELS MAINTENANCE BETWEEN DIFFERENT PROFILES AND SITUATIONS	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.	From enrollment to the end of treatment at 8 hours.

Collaborators and Investigators

• Sponsor: Aether Tech S.L.
• Collaborators: Hospital Clinic of Barcelona; Hospital Universitario Fundación Jiménez Díaz

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Actual): June 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Hypoxia; Respiratory failure; Hyperxia; Oxigenotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiratory Insufficiency; Hypoxia
• Other Study ID Numbers: FJD-EMILY-23-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No