NCT06952816

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

April 8, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

April 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

April 8, 2025

Last Update Submit

January 8, 2026

Conditions

Chronic Respiratory FailureAcute Respiratory Failure

Keywords

Respiratory failureHypoxiaHyperxiaOxigenotherapy

Outcome Measures

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.

    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

    From enrollment to the end of treatment at 8 hours.

  • ALERT SYSTEM - MEASUREMENT OF THE NUMBER OF SYSTEM ALERTS

    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

    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

    From enrollment to the end of treatment at 8 hours.

  • VERSATILITY - COMPARISON OF BLOOD OXYGEN SATURATION LEVELS MAINTENANCE BETWEEN DIFFERENT PROFILES AND SITUATIONS

    From enrollment to the end of treatment at 8 hours.

Study Arms (1)

Patients with respiratory failure

EXPERIMENTAL

Patients with respiratory failure who meet the inclusion criteria and none of the exclusion criteria.

Device: Emily.AI

Interventions

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.

Patients with respiratory failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Hemodynamic instability.
  • Severe temperature changes.
  • Hemoglobinopathies, severe anemia, severe acidosis, or severe alkalosis.
  • Anatomical disturbances.
  • Pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Respiratory InsufficiencyHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2025

First Posted

May 1, 2025

Study Start

April 23, 2025

Primary Completion

June 30, 2025

Study Completion (Estimated)

December 30, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

ES(2)