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SUSPENDED
NCT06952816
NA

Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit

Sponsor: Aether Tech S.L.

View on ClinicalTrials.gov

Summary

This 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 with acute respiratory failure admitted to the Respiratory Intermediate Care Unit (RICU) of Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) receive oxygen titrated automatically by EMILY.AI and, in the same monitoring session, oxygen titrated manually by the nursing team while the device records saturation and flow. The study measures how much of the time patients stay within their target saturation range under each method, how fast the device corrects deviations, the alerts it generates, nursing workload, oxygen use and patient comfort. This substudy is part of clinical investigation FJD-EMILY-23-02, whose other substudies are registered in separate records.

Official title: Functional, Clinical, and Predictive Validation Study of the EMILY AI Device in Patients With Acute and Chronic Respiratory Failure: Respiratory Intermediate Care Unit Substudy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-04-15

Completion Date

2027-03-30

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DEVICE

Emily.AI

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

OTHER

Manual oxygen titration

Standard care: oxygen flow set and adjusted by the unit's nursing team according to usual practice. The EMILY.AI device stays connected and records signals and flow but does not control delivery.

Locations (1)

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain