Automated Versus Manual Oxygen Titration With the EMILY.AI Device in Hospitalized Patients With Acute Respiratory Failure
NCT07932847, Not applicable, Not yet recruiting, Aether Tech S.L.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Automated Versus Manual Oxygen Titration With the EMILY.AI Device in Hospitalized Patients With Acute Respiratory Failure | ClinicalTrials.gov |
| NCT number | NCT07932847 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Aether Tech S.L. | ClinicalTrials.gov |
| Conditions | Acute Respiratory Failure, Acute-on-chronic Respiratory Failure, COPD Exacerbation, Pneumonia, Interstitial Lung Diseases | ClinicalTrials.gov |
| Interventions | EMILY.AI closed-loop oxygen titration, Manual oxygen titration | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Percentage of time with SpO2 within the target range | From randomization to hospital discharge, up to 30 days. | 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. | ClinicalTrials.gov |
| Secondary | Proportion of participants with SpO2 in range more than 95% of the time | From randomization to hospital discharge, up to 30 days. | Proportion of participants in each arm whose SpO2 stays within their target range for more than 95% of the monitored time. | ClinicalTrials.gov |
| Secondary | Time with SpO2 below the target range | From randomization to hospital discharge, up to 30 days. | Percentage of monitored time with SpO2 below the target range for the type of respiratory failure (hypoxaemia). | ClinicalTrials.gov |
| Secondary | Time with SpO2 above the target range | From randomization to hospital discharge, up to 30 days. | Percentage of monitored time with SpO2 above the target range while oxygen is being delivered (hyperoxaemia). | ClinicalTrials.gov |
| Secondary | Nursing oxygen flow adjustments | From randomization to hospital discharge, up to 30 days. | Number of oxygen flow changes and oxygen interface changes made by nursing staff per shift (morning, afternoon, night). | ClinicalTrials.gov |
| Secondary | Number of nursing vital sign measurements per shift | From randomization to hospital discharge, up to 30 days. | 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. | ClinicalTrials.gov |
| Secondary | Calls to the physician | From randomization to hospital discharge, up to 30 days. | Number of calls to the physician related to desaturation, oxygen flow changes or abnormal vital signs. | ClinicalTrials.gov |
| Secondary | Total oxygen delivered | From randomization to hospital discharge, up to 30 days. | Total oxygen delivered (litres) during the hospital stay. | ClinicalTrials.gov |
| Secondary | Mean oxygen flow | From randomization to hospital discharge, up to 30 days. | Mean oxygen flow (litres per minute) delivered during the hospital stay. | ClinicalTrials.gov |
| Secondary | Length of hospital stay | From randomization to hospital discharge, up to 30 days. | Days from randomization to hospital discharge. | ClinicalTrials.gov |
| Secondary | Escalation to a higher level of respiratory support | From randomization to hospital discharge, up to 30 days. | 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. | ClinicalTrials.gov |
| Secondary | Device alerts | From randomization to hospital discharge, up to 30 days. | Number of alerts generated by EMILY.AI related to oxygenation or vital signs per participant during the hospital stay. | ClinicalTrials.gov |
| Secondary | Percentage of device alerts corresponding to a true clinical change | From randomization to hospital discharge, up to 30 days. | Percentage of EMILY.AI alerts confirmed by the clinical team as corresponding to a true clinical change. | ClinicalTrials.gov |
| Secondary | Change in arterial partial pressure of oxygen (PaO2) | At randomization and at hospital discharge (up to 30 days). | Change in PaO2 (mmHg) measured by arterial blood gas analysis between randomization and hospital discharge. | ClinicalTrials.gov |
| Secondary | Change in arterial partial pressure of carbon dioxide (PaCO2) | At randomization and at hospital discharge (up to 30 days). | Change in PaCO2 (mmHg) measured by arterial blood gas analysis between randomization and hospital discharge. | ClinicalTrials.gov |
| Secondary | Change in arterial pH | At randomization and at hospital discharge (up to 30 days). | Change in arterial pH (pH units) measured by arterial blood gas analysis between randomization and hospital discharge. | ClinicalTrials.gov |
| Secondary | Change in dyspnoea measured with the modified Borg Dyspnoea Scale | At randomization and at hospital discharge (up to 30 days). | 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. | ClinicalTrials.gov |
| Secondary | Satisfaction with oxygen therapy measured with a 5-point Likert scale | At hospital discharge (up to 30 days). | 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. | ClinicalTrials.gov |
| Other | Intercurrent events | From randomization to hospital discharge, up to 30 days. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)