RecruitingNot ApplicableNCT06952816

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


Sponsor

Aether Tech S.L.

Enrollment

20 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria5

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

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Interventions

DEVICEEmily.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.


Locations(2)

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

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NCT06952816


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