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Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit

RecruitingNAAges 18 Years - anyAllAether Tech S.L.
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In plain words

What the trial is, and whether it could suit you

This study evaluates EMILY.AI, an investigational (non-CE-marked) smart oxygen valve that automatically adjusts the oxygen flow delivered to a patient, second by second, according to oxygen saturation (SpO2), heart rate and respiratory rate measured by a pulse oximeter. Adults with acute respiratory failure admitted to the Respiratory Intermediate Care Unit (RICU) of Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) receive oxygen titrated automatically by EMILY.AI and, in the same monitoring session, oxygen titrated manually by the nursing team while the device records saturation and flow. The study measures how much of the time patients stay within their target saturation range under each method, how fast the device corrects deviations, the alerts it generates, nursing workload, oxygen use and patient comfort. This substudy is part of clinical investigation FJD-EMILY-23-0

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📋 Eligibility rules (as published)
Inclusion Criteria: * Men and women over 18 years of age or older. * Admitted to the Respiratory Intermediate Care Unit with acute respiratory failure, defined as baseline arterial PaO2 below 60 mmHg or the need for supplemental oxygen to maintain SpO2 above 90%. Patients on long-term oxygen therapy are eligible if a clinical deterioration requires a higher-than-usual oxygen flow to maintain SpO2 above 90%. * Spontaneous breathing without positive-pressure ventilatory support (invasive or non-invasive mechanical ventilation, or CPAP) for at least 8 consecutive hours. * Able to understand the study and sign informed consent. Exclusion Criteria: * Hemodynamic instability or need for vasoactive drugs. * Severe temperature changes (axillary temperature above 39 °C or below 35 °C). * Hemoglobinopathies or severe anemia (hemoglobin below 7 g/dL). * Severe acidosis (pH below 7.20) or severe alkalosis (pH above 7.55). * Anatomical abnormalities preventing correct placement of the pulse oximeter. * Pregnancy or breastfeeding (women of childbearing potential require a negative pregnancy test at screening). * Oxygen flow requirement exceeding the valve capacity (more than 40 L/min).
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What it tests

  • Emily.AI
  • Manual oxygen titration
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Where

1 site
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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