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NCT Number: NCT06489379

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • Pregnancy;
  • Patient's refusal to participate.

Treatment and study plan

High Flow Nasal Cannula

Device

humidified and heated oxygen

Standard oxygen

Other

oxygen delivery through Venturi mask

Primary outcomes

  1. Early deterioration

    Time frame: 24 hours

    occurrence of any of the following from randomization: respiratory worsening; respiratory acidosis; severe respiratory distress; start of non-invasive ventilation; necessity of endotracheal intubation; development of shock; death.

Secondary outcomes

  1. Development of respiratory acidosis

    Time frame: 2, 12 and 24 hours

    arterial pH

  2. Development of hypercapnia

    Time frame: 2, 12 and 24 hours

    arterial pCO2

  3. Worsening hypoxemia

    Time frame: 2, 12 and 24 hours

    P/F ratio

  4. Worsening respiratory distress

    Time frame: 2, 12 and 24 hours

    respiratory frequency

  5. duration of any type of ventilatory support

    Time frame: 90 days

    hours of ventilatory support

  6. rate of ICU admission

    Time frame: 90 days

    number of patients admitted to ICU

  7. hospital length-of-stay

    Time frame: 30 days

    duration of hospitalization

  8. in-hospital mortality

    Time frame: 90 days

    death during hospitalization

  9. ICU length-of-stay

    Time frame: 90 days

    duration of ICU stay

  10. ICU mortality

    Time frame: 90 days

    death in ICU

  11. development of complications

    Time frame: 90 days

    composite outcome of septic shock, nosocomial pneumonia, cardiac arrhythmia, cardiac arrest, delirium

  12. level of dyspnea

    Time frame: 24 hours

    utilizing Borg scale

  13. patient comfort

    Time frame: 24 hours

    utilizing visual analogue scale

  14. clinical setting after ED stabilization

    Time frame: 24 hours

    type of ward admission

  15. standard vs asymmetrical high-flow nasal cannula

    Time frame: 24 hours

    rate of early deterioration in the treatment group will be compared between patients treated with standard or asymmetrical high-flow nasal cannula

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Franceschi, MD

CONTACT

[email protected]

+390630156627

Gianluca Tullo, MD

CONTACT

[email protected]

+393926595850

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: GLAMOUR

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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