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

Aether Tech S.L.

Status: Enrolling

Conditions: Chronic Respiratory Failure; Acute Respiratory Failure

Treatments: Device: Emily.AI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06952816

FJD-EMILY-23-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patients with respiratory failure

Experimental group

Description:

Patients with respiratory failure who meet the inclusion criteria and none of the exclusion criteria.

Treatment:

Device: Emily.AI