Validation of the EMILY AI Device for Managing Respiratory Failure
Functional, Clinical, and Predictive Validation Study of the EMILY AI Device in Patients With Acute and Chronic Respiratory Failure
This study is testing a new AI device that automatically adjusts oxygen levels for people with breathing problems to see if it helps them breathe better and stay safe in different settings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aether Tech S.L. Industry-sponsored |
| Locations | 2 sites (Madrid and 1 other locations) |
| Trial ID | NCT06952816 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to validate the EMILY AI device, which automatically adjusts oxygen flow rates for patients experiencing acute and chronic respiratory failure. The study will assess the device's efficacy, safety, and adaptability in both hospital and outpatient settings, focusing on its ability to maintain stable oxygen saturation levels. Patients will be monitored in various environments, including intermediate care units and during physical activity, to evaluate the device's performance in real-time. The goal is to enhance oxygen therapy management and reduce medical errors associated with manual titration.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are admitted to an intermediate respiratory care unit with acute respiratory failure.
Not a fit: Patients with hemodynamic instability, severe temperature changes, or specific blood disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve the management of oxygen therapy, leading to better patient outcomes and reduced healthcare costs.
How similar studies have performed: Other studies have shown promise in using automated systems for oxygen therapy, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid and 1 other locations
- Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain (Recruiting)
- Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.