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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• EFFICACY - EVALUATION OF THE RATE THE DEVICE MAINTAINS BLOOD OXYGEN SATURATION LEVELS — From enrollment to the end of treatment at 8 hours.
  Evaluation of the rate that the device maintains blood oxygen saturation levels measured by pulse oximetry within predetermined ranges in patients diagnosed with ARF (hypoxemic patients: 94-98%; hypercapnic patients: 92-94%) without providing less or more oxygen than required to keep the patient within the defined range.

Trial sites (2)

Other trials for the same condition