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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jul 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called High Flow Nasal Oxygen (HFNO) can help patients who are experiencing severe breathing problems, known as acute hypoxemic respiratory failure, when they arrive at the emergency room. The goal is to see if using HFNO early on can prevent these patients from getting worse compared to standard oxygen therapy. The trial will enroll adults aged 18 and older who meet specific health criteria, such as having a certain level of oxygen in their blood after trying a different type of oxygen mask.

If you or a loved one is eligible and decides to participate, you will be assigned to receive either HFNO or the standard treatment. The trial is still in the planning stages and is not recruiting participants yet, but it aims to gather important information that could improve care for patients with serious breathing issues in the future. It's also important to note that certain health conditions, like severe asthma or heart problems, might prevent someone from being eligible for this study.

Gender

ALL

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.