Validation Study of the EMILY AI Device in Acute and Chronic Respiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAether Tech S.L.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Hemodynamic instability.
Severe temperature changes.
Hemoglobinopathies, severe anemia, severe acidosis, or severe alkalosis.
Anatomical disturbances.
Trial design
Design model
Single group
Treatments tested in this trial
Emily.AI
DeviceEMILY.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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patients with respiratory failureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
EFFICACY - EVALUATION OF THE RATE THE DEVICE MAINTAINS BLOOD OXYGEN SATURATION LEVELS
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.
Time frame
From enrollment to the end of treatment at 8 hours.Secondary outcomes
1
ACCURACY - MEASUREMENT OF THE SYSTEM'S ACTION SPEED CORRECTING THE OXYGEN SATURATION LEVELS
Calculate the speed of action of the system from 1) detection of saturation out-of-range to the start of correction and 2) until the patient returns to the defined saturation range
Time frame
From enrollment to the end of treatment at 8 hours.2
ALERT SYSTEM - MEASUREMENT OF THE NUMBER OF SYSTEM ALERTS
Measure the number of times EMILY alerts about a change in the oxygen saturation of monitored patients using its alarm system.
Time frame
From enrollment to the end of treatment at 8 hours.3
ALERT SYSTEM - EVALUATION OF THE AUTHENTICITY OF THE SYSTEM ALERTS BY COMPARING THE OXYGEN SATURATION LEVELS WITH A CONVENTIONAL SYSTEM
Evaluate the alarm's authenticity by checking oxygen saturation with a conventional system and, in case of discrepancies, by arterial blood gas analysis.
Time frame
From enrollment to the end of treatment at 8 hours.4
EFFICIENCY - MEASUREMENT OF THE NUMBER OF TIMES THE MEDICAL AND NURSING TEAM MUST ADJUST THE OXYGENATION
Evaluate the need for nursing and medical team intervention, measured by the number of times they must visit to adjust oxygenation or address symptoms related to oxygenation, primarily cardiorespiratory symptoms.
Time frame
From enrollment to the end of treatment at 8 hours.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aether Tech S.L.
Lead sponsor
Hospital Universitario Fundación Jiménez Díaz
Collaborator
Hospital Clinic of Barcelona
Collaborator
Source ClinicalTrials.gov