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

Not Applicable

Not yet recruiting

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Other: standard oxygen; Device: high flow nasal cannula

• Registration Number: NCT06489379
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-21
• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 234

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard oxygen	standard oxygen	-
high flow nasal oxygen	high flow nasal cannula	-

Primary Outcome Measures

Name	Time	Method
Early deterioration	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 Outcome Measures

Name	Time	Method
Development of hypercapnia	2, 12 and 24 hours	arterial pCO2
level of dyspnea	24 hours	utilizing Borg scale
Worsening respiratory distress	2, 12 and 24 hours	respiratory frequency
rate of ICU admission	90 days	number of patients admitted to ICU
hospital length-of-stay	30 days	duration of hospitalization
Worsening hypoxemia	2, 12 and 24 hours	P/F ratio
duration of any type of ventilatory support	90 days	hours of ventilatory support
in-hospital mortality	90 days	death during hospitalization
ICU length-of-stay	90 days	duration of ICU stay
patient comfort	24 hours	utilizing visual analogue scale
standard vs asymmetrical high-flow nasal cannula	24 hours	rate of early deterioration in the treatment group will be compared between patients treated with standard or asymmetrical high-flow nasal cannula
Development of respiratory acidosis	2, 12 and 24 hours	arterial pH
ICU mortality	90 days	death in ICU
development of complications	90 days	composite outcome of septic shock, nosocomial pneumonia, cardiac arrhythmia, cardiac arrest, delirium
clinical setting after ED stabilization	24 hours	type of ward admission