Clinical trial NCT06489379: High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room
Official title: High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room: the GLAMOUR Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome, Adult
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Early deterioration
timeFrame: 24 hours
Secondary outcomes:
measure: Development of respiratory acidosis
timeFrame: 2, 12 and 24 hours
measure: Development of hypercapnia
timeFrame: 2, 12 and 24 hours
measure: Worsening hypoxemia
timeFrame: 2, 12 and 24 hours
measure: Worsening respiratory distress
timeFrame: 2, 12 and 24 hours
measure: duration of any type of ventilatory support
timeFrame: 90 days
measure: rate of ICU admission
timeFrame: 90 days
measure: hospital length-of-stay
timeFrame: 30 days
measure: in-hospital mortality
timeFrame: 90 days
measure: ICU length-of-stay
timeFrame: 90 days
measure: ICU mortality
timeFrame: 90 days
measure: development of complications
timeFrame: 90 days
measure: level of dyspnea
timeFrame: 24 hours
measure: patient comfort
timeFrame: 24 hours
measure: clinical setting after ED stabilization
timeFrame: 24 hours
measure: standard vs asymmetrical high-flow nasal cannula
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
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