Chronic Respiratory FailureNCT06952816
Validation Study of the EMILY AI Device in Acute and Chronic Respiratory Failure
A study testing Emily.AI in people with Chronic Respiratory Failure and Acute Respiratory Failure, run by Aether Tech S.L. at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure, Acute Respiratory Failure
- What is being tested?
- Emily.AI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- 23 Apr 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hemodynamic instability.
- Severe temperature changes.
- Hemoglobinopathies, severe anemia, severe acidosis, or severe alkalosis.
- Anatomical disturbances.
- Pregnancy or breastfeeding.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid
Sarah Beatrice Heili Frades Zimmermann MD, PhD, +34 915 50 48 00, SHeili@fjd.es
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid
Sarah Beatrice Heili Frades Zimmermann MD, PhD, +34 915 50 48 00, SHeili@fjd.es
Alba Naya Prieto, MD, +34 915 50 48 00, alba.naya@fjd.es
About this study
Official title: Functional, Clinical, and Predictive Validation Study of the EMILY AI Device in Patients With Acute and Chronic Respiratory Failure
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.
Read the detailed description
There is no doubt about the efficacy of oxygen therapy in the treatment of acute and chronic respiratory failure in different clinical settings. However, its therapeutic dosage is not as strict as that of other treatments. Hypoxemia has been associated with increased mortality in multiple pathologies and clinical situations. Furthermore, the liberal use of oxygen therapy has also demonstrated harmful effects. Therefore, titration of this therapy is necessary. Traditionally, this has been performed manually, although in recent years, new devices have been developed to automatically adjust O2 flow rates to the needs of each patient, with the goal of maintaining stable oxygen saturations. These systems have the potential to reduce medical error, improve morbidity and mortality, and reduce care costs.
This study is a clinical investigation using a non-CE marked medical device, prospectively validating the device's functional status. The objective is to evaluate its efficacy and safety in patients with respiratory failure, both in hospital and outpatient settings.
- Being tested
- Emily.AI
- Keywords
- Respiratory failure, Hypoxia, Hyperxia, Oxigenotherapy
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emily.AIDevice
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 group | Role | What they receive |
|---|---|---|
| Patients with respiratory failure | Experimental | Patients with respiratory failure who meet the inclusion criteria and none of the exclusion criteria. Receives: Device: Emily.AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 8 hours.
Secondary outcomes (5)
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
Measured: From enrollment to the end of treatment at 8 hours.
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.
Measured: From enrollment to the end of treatment at 8 hours.
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.
Measured: From enrollment to the end of treatment at 8 hours.
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.
Measured: From enrollment to the end of treatment at 8 hours.
VERSATILITY - COMPARISON OF BLOOD OXYGEN SATURATION LEVELS MAINTENANCE BETWEEN DIFFERENT PROFILES AND SITUATIONS
Evaluation of the rate that the device maintains blood oxygen saturation levels in different profiles, such as patients with pure hypoxemia and those with hypercapnia, and in different clinical situations such as bed rest, sitting, eating, or receiving physical therapy. This rate will be compared across these different profiles and situations.
Measured: From enrollment to the end of treatment at 8 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start23 Apr 2025
- Primary completion30 Jun 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aether Tech S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Fundación Jiménez Díaz, Hospital Clinic of Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952816
- Sponsor's protocol ID
- FJD-EMILY-23-02
- Status last verified
- Jan 2026
- First submitted
- 8 Apr 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional, Clinical, and Predictive Validation Study of the EMILY AI Device in Patients With Acute and Chronic Respiratory Failure
- ClinicalTrials.gov ID
- NCT06952816
- Acronym / sponsor ID
- FJD-EMILY-23-02
- Keywords
- Respiratory failure, Hypoxia, Hyperxia, Oxigenotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aether Tech S.L.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Fundación Jiménez Díaz, Hospital Clinic of Barcelona
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is no doubt about the efficacy of oxygen therapy in the treatment of acute and chronic respiratory failure in different clinical settings. However, its therapeutic dosage is not as strict as that of other treatments. Hypoxemia has been associated with increased mortality in multiple pathologies and clinical situations. Furthermore, the liberal use of oxygen therapy has also demonstrated harmful effects. Therefore, titration of this therapy is necessary. Traditionally, this has been performed manually, although in recent years, new devices have been developed to automatically adjust O2 flow rates to the needs of each patient, with the goal of maintaining stable oxygen saturations. These systems have the potential to reduce medical error, improve morbidity and mortality, and reduce care costs.
This study is a clinical investigation using a non-CE marked medical device, prospectively validating the device's functional status. The objective is to evaluate its efficacy and safety in patients with respiratory failure, both in hospital and outpatient settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with respiratory failure | Experimental | Device: Emily.AIPatients with respiratory failure who meet the inclusion criteria and none of the exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Hemodynamic instability.
- Severe temperature changes.
- Hemoglobinopathies, severe anemia, severe acidosis, or severe alkalosis.
- Anatomical disturbances.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emily.AIEMILY.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. | Device | Patients with respiratory failure |
Primary outcome
EFFICACY - EVALUATION OF THE RATE THE DEVICE MAINTAINS BLOOD OXYGEN SATURATION LEVELS
Time frame: 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.
5 secondary outcomes
ACCURACY - MEASUREMENT OF THE SYSTEM'S ACTION SPEED CORRECTING THE OXYGEN SATURATION LEVELS
Time frame: From enrollment to the end of treatment at 8 hours.
ALERT SYSTEM - MEASUREMENT OF THE NUMBER OF SYSTEM ALERTS
Time frame: From enrollment to the end of treatment at 8 hours.
ALERT SYSTEM - EVALUATION OF THE AUTHENTICITY OF THE SYSTEM ALERTS BY COMPARING THE OXYGEN SATURATION LEVELS WITH A CONVENTIONAL SYSTEM
Time frame: From enrollment to the end of treatment at 8 hours.
EFFICIENCY - MEASUREMENT OF THE NUMBER OF TIMES THE MEDICAL AND NURSING TEAM MUST ADJUST THE OXYGENATION
Time frame: From enrollment to the end of treatment at 8 hours.
VERSATILITY - COMPARISON OF BLOOD OXYGEN SATURATION LEVELS MAINTENANCE BETWEEN DIFFERENT PROFILES AND SITUATIONS
Time frame: From enrollment to the end of treatment at 8 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emily.AI in people with Chronic Respiratory Failure and Acute Respiratory Failure, run by Aether Tech S.L. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY - EVALUATION OF THE RATE THE DEVICE MAINTAINS BLOOD OXYGEN SATURATION LEVELS (time frame: From enrollment to the end of treatment at 8 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.