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High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room

High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room: the GLAMOUR Study

NCT06489379•Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Summary

The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitted to the ER because of acute hypoxemic respiratory failure.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years;
•PaO2/FiO2 ratio between 250 and 150 mmHg or SpO2/FiO2 ratio between 190 and 274, after at least 15 minutes of spontaneous breathing through a Venturi mask (VM), with a FiO2 targeted at a SpO2 94-97%;
•Respiratory rate(RR)≤35breaths/min,afteratleast15minutesofspontaneous breathing through a VM, with a FiO2 targeted at a SpO2 94-97%;
•PaCO2 ≤ 45 mmHg;
•Unilateral or bilateral infiltrate(s), as detected with chest radiography and/or computed tomography and/or with lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses. Infiltrates at lung ultrasound are defined as presence of focal B-lines, consolidations (with irregular marginal contour, air bronchogram, air trapping sign) and irregularity of the pleural line.

Exclusion Criteria

•Respiratory failure due to:
•* Acute asthma or COPD exacerbation,
•* Cardiac failure or fluid overload as primary cause of respiratory failure;
•Unstable angina or ongoing acute myocardial infarction;
•Acute respiratory acidosis with pH \< 7.35 and PaCO2 \> 45 mmHg;
•Hemodynamic instability and/or use of vasopressors/inotropes;
•Altered mental status (Kelly \>3), see Figure 1;(18)
•Contraindications to NIV (high risk of aspiration pneumonia, impaired airways protection, head-facial trauma and/or burns, uncooperative patient, cranial/thoracic/abdominal open wounds);
•Indications to urgent intubation performed according to the clinician in charge;
•Body Mass Index \> 35 kg/m2;
+2 more criteria

Key Dates

Start Date

July 1, 2024

Primary Completion Date

July 1, 2025

Completion Date

July 1, 2026

Last Updated

July 5, 2024

Enrollment

234

ESTIMATED participants

Conditions

Respiratory Distress Syndrome, Adult

Interventions

high flow nasal cannula

DEVICE

standard oxygen

OTHER

Contacts

Francesco Franceschi, MD

CONTACT

+390630156627 francesco.franceschi@policlinicogemelli.it

Gianluca Tullo, MD

CONTACT

+393926595850 gianlucatullo@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room

Inclusion Criteria

Exclusion Criteria

Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department

Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER

Ventilation and Perfusion in the Respiratory System

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