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

NCT06489379 | Not Yet Recruiting FDA Device

• 1 other identifier: 6697
• Study Type: interventional
• Target: 234
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Distress Syndrome, Adult

Outcome Measures

Primary Outcomes (1)

• Early deterioration

  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.

  24 hours

Secondary Outcomes (15)

• Development of respiratory acidosis

  2, 12 and 24 hours

• Development of hypercapnia

  2, 12 and 24 hours

• Worsening hypoxemia

  2, 12 and 24 hours

• Worsening respiratory distress

  2, 12 and 24 hours

• duration of any type of ventilatory support

  90 days

Study Arms (2)

standard oxygen

ACTIVE COMPARATOR

Other: standard oxygen

high flow nasal oxygen

EXPERIMENTAL

Device: high flow nasal cannula

Interventions

high flow nasal cannula DEVICE

humidified and heated oxygen

high flow nasal oxygen

standard oxygen OTHER

oxygen delivery through Venturi mask

standard oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Related Publications (26)

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MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Francesco Franceschi, MD

CONTACT

+390630156627; francesco.franceschi@policlinicogemelli.it

Gianluca Tullo, MD

CONTACT

+393926595850; gianlucatullo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 5, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-07