NCT06952816

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Aether Tech S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Respiratory Failure
• Acute Respiratory Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-23
• Primary completion: 2025-06-30
• Completion: 2026-12-30
• First posted: 2025-05-01
• Last updated: 2026-01-09

Locations

2 sites across 1 country: Spain