An interventional study of EMILY.AI closed-loop oxygen titration and Manual oxygen titration in Acute Respiratory Failure, Acute-on-chronic Respiratory Failure and COPD Exacerbation, sponsored by Aether Tech S.L.. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Aether Tech S.L. · Not applicable, Interventional, and Treatment
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Among 79 studies in Pneumonia with a site in Spain — 12 open to participants now, 13 under way, 4 of them phase 3. Pneumonia · Spain.
Among the 79 studies in Pneumonia with a site in Spain, this one is the 44th largest by planned enrollment of the 67 interventional ones that give a count, is the only one that started in 2027, is one of 13 with no phase, reaches primary completion later than 10 of the 12 other live ones, and was the 79th registered.
1,566 studies on the registry are indexed under Pneumonia; 266 are open to participants now.
Browse Pneumonia studies →12 of the 79 studies in Pneumonia with a site in Spain are open now. Recruiting first, the newest first:
Pfizer · Sites in Spain, United States, Argentina and 15 more countries
Ages 18+
Iconic Solutions By Murcia SL · Sites in Spain
Ages 18+
Pfizer · Sites in Spain, United States, Argentina and 16 more countries
Ages 12+
PEACHES BIOTECH · Sites in Spain
Ages 18+
Instituto de Investigacion Sanitaria La Fe · Sites in Spain
Ages 18–100
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 158 Pneumonia studies recruiting now, 84 (53%) set no upper age limit and 47 (30%) stop at 75 or younger; 41 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 21 · Phase 3 33 · Phase 4 6
First in 2000; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is below the median of 129 across 976 interventional studies indexed under Pneumonia.
Median enrollment 174 across the 67 interventional studies, 763 across the 12 observational. Of the 56 that completed or were terminated, 18 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
41 of 79 have an industry lead sponsor. The 10 most frequent:
Aether Tech S.L. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Aether Tech S.L. has 1 study filed under Pneumonia — fewer than ten, so there is no comparison to draw.
6 of the studies in Pneumonia with a site in Spain that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07013474Phase 3PfizerA Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised | 2027-09-28 |
| NCT06679140Phase 3PfizerA Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease | 2027-10-01 |
| NCT07432191Iconic Solutions By Murcia SLMedical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning. | 2026-12 |
| NCT05452941PfizerA Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting | 2027-06-04 |
| NCT07883902Santiago Lopez GilExpanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection | 2027-07 |
Add all 6 to your calendar (.ics) → With an account.
Among the 79 studies in Pneumonia with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This randomized 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 admitted to the pulmonology ward of Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) with acute respiratory failure are randomly assigned to receive oxygen titrated automatically by EMILY.AI or oxygen managed as usual by the nursing team, from randomization until hospital discharge. All participants wear the device; in the usual-care group it only records data.
The study compares the time patients stay within their target saturation range, episodes of low and high oxygen, nursing workload, oxygen use, length of stay and patient experience. This substudy is part of clinical investigation FJD-EMILY-23-02, whose other substudies are registered in separate records.
Background On conventional hospital wards, oxygen is usually given at a fixed flow and saturation is checked about once per nursing shift, so periods of hypoxaemia or hyperoxaemia can go undetected. EMILY.AI combines a medical-grade oxygen valve with an edge-computing fuzzy-logic algorithm that sets the oxygen flow every second, with continuous logging of physiological signals and delivered flow.
Design Prospective, single-blind (participant), randomized, parallel-group study. Participants are randomized 1:1 to the EMILY arm (automatic titration) or the MANUAL arm (usual care with nursing monitoring every 8 hours and a fixed oxygen prescription), using permuted blocks of 4 stratified by main admission diagnosis (COPD exacerbation, pneumonia, interstitial lung disease, other) and prior long-term home oxygen therapy (yes or no). Allocation takes place after eligibility is confirmed and informed consent is signed.
Intervention and follow-up All participants are connected to the EMILY.AI device continuously from randomization until hospital discharge. In the EMILY arm the device titrates oxygen autonomously to keep SpO2 within the target range for the type of respiratory failure (hypoxaemic 91-97%; hypercapnic 91-94%). In the MANUAL arm the device works in fixed mode, recording SpO2, heart rate and respiratory rate without changing the flow, and nurses adjust oxygen as usual. Conventional back-up oxygen is available at all times.
Sample size 100 participants: 80 planned for the main comparison and approximately 20 added by protocol amendment (CIP v8.0) to further validate an adjustment of the algorithm parameter that sets the minimum oxygen flow in hypoxaemic patients. All 100 are randomized in the same way. As a pilot functional validation, no formal sample size calculation was performed.
The protocol FJD-EMILY-23-02 also includes a substudy in the Respiratory Intermediate Care Unit and an exercise substudy (six-minute walk test), registered separately.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Automatic oxygen titration by EMILY.AI 24 hours a day from randomization to hospital discharge, targeting SpO2 91-97% (hypoxaemic) or 91-94% (hypercapnic).
Device: EMILY.AI closed-loop oxygen titration
Usual care: fixed oxygen prescription adjusted by nursing staff, with vital signs checked every 8 hours. The EMILY.AI device is connected in fixed mode and only records data.
Other: Manual oxygen titration
Investigational smart oxygen valve with an embedded fuzzy-logic algorithm that adjusts oxygen flow every second from pulse-oximetry SpO2, heart rate and respiratory rate to keep SpO2 within a target range. Other names: EMILY.AI Smart Valve
Usual care: oxygen flow set and adjusted by the ward nursing team according to standard practice. The EMILY.AI device stays connected in fixed mode, recording signals but not controlling delivery.
Percentage of time with SpO2 within the target range
Percentage of monitored time with SpO2, measured continuously by the device's pulse oximeter, within the target range for the type of respiratory failure (hypoxaemic 91-97%; hypercapnic 91-94%). Compared between the EMILY and MANUAL arms.
Time frame: From randomization to hospital discharge, up to 30 days.
Proportion of participants with SpO2 in range more than 95% of the time
Proportion of participants in each arm whose SpO2 stays within their target range for more than 95% of the monitored time.
Time frame: From randomization to hospital discharge, up to 30 days.
Time with SpO2 below the target range
Percentage of monitored time with SpO2 below the target range for the type of respiratory failure (hypoxaemia).
Time frame: From randomization to hospital discharge, up to 30 days.
Time with SpO2 above the target range
Percentage of monitored time with SpO2 above the target range while oxygen is being delivered (hyperoxaemia).
Time frame: From randomization to hospital discharge, up to 30 days.
Nursing oxygen flow adjustments
Number of oxygen flow changes and oxygen interface changes made by nursing staff per shift (morning, afternoon, night).
Time frame: From randomization to hospital discharge, up to 30 days.
Number of nursing vital sign measurements per shift
Total number of individual vital sign measurements taken by nursing staff per 8-hour shift, where each recording of SpO2, temperature, blood pressure, heart rate or respiratory rate counts as one measurement. For each participant, the counts are averaged across all shifts of the stay and reported as the mean number of measurements per shift.
Time frame: From randomization to hospital discharge, up to 30 days.
Calls to the physician
Number of calls to the physician related to desaturation, oxygen flow changes or abnormal vital signs.
Time frame: From randomization to hospital discharge, up to 30 days.
Total oxygen delivered
Total oxygen delivered (litres) during the hospital stay.
Time frame: From randomization to hospital discharge, up to 30 days.
Mean oxygen flow
Mean oxygen flow (litres per minute) delivered during the hospital stay.
Time frame: From randomization to hospital discharge, up to 30 days.
Length of hospital stay
Days from randomization to hospital discharge.
Time frame: From randomization to hospital discharge, up to 30 days.
Escalation to a higher level of respiratory support
Proportion of participants requiring high-flow nasal cannula, non-invasive ventilation, or transfer to the Respiratory Intermediate Care Unit or ICU due to respiratory or hemodynamic deterioration.
Time frame: From randomization to hospital discharge, up to 30 days.
Device alerts
Number of alerts generated by EMILY.AI related to oxygenation or vital signs per participant during the hospital stay.
Time frame: From randomization to hospital discharge, up to 30 days.
Percentage of device alerts corresponding to a true clinical change
Percentage of EMILY.AI alerts confirmed by the clinical team as corresponding to a true clinical change.
Time frame: From randomization to hospital discharge, up to 30 days.
Change in arterial partial pressure of oxygen (PaO2)
Change in PaO2 (mmHg) measured by arterial blood gas analysis between randomization and hospital discharge.
Time frame: At randomization and at hospital discharge (up to 30 days).
Change in arterial partial pressure of carbon dioxide (PaCO2)
Change in PaCO2 (mmHg) measured by arterial blood gas analysis between randomization and hospital discharge.
Time frame: At randomization and at hospital discharge (up to 30 days).
Change in arterial pH
Change in arterial pH (pH units) measured by arterial blood gas analysis between randomization and hospital discharge.
Time frame: At randomization and at hospital discharge (up to 30 days).
Change in dyspnoea measured with the modified Borg Dyspnoea Scale
Change between randomization and hospital discharge in dyspnoea measured with the modified Borg Dyspnoea Scale, which ranges from 0 (no breathlessness at all) to 10 (maximal breathlessness). Higher scores mean a worse outcome.
Time frame: At randomization and at hospital discharge (up to 30 days).
Satisfaction with oxygen therapy measured with a 5-point Likert scale
Participant-reported satisfaction with oxygen therapy at hospital discharge, measured with a single-item 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores mean a better outcome.
Time frame: At hospital discharge (up to 30 days).
Intercurrent events
Number of participants with falls with clinical consequences, non-respiratory nosocomial infection, acute cardiovascular events, major bleeding, decompensation of non-respiratory comorbidity, social problems prolonging stay, or unplanned procedures.
Time frame: From randomization to hospital discharge, up to 30 days.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Dec 2027, 10 months later.
Of 265 interventional studies with no phase under Pneumonia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Aether Tech S.L.