Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure: an Open Label, Pilot, Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Failure With Hypoxia
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 110
- Locations
- 5
- Primary Endpoint
- Respiratory-support free days within 28 days from randomization
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Helmet noninvasive ventilation and high-flow nasal cannula are novel tools for the first-line treatment of acute hypoxemic respiratory failure. Compared to face-mask noninvasive ventilation in randomized trials, both have improved clinical outcome of patients with moderate-to-severe hypoxemic respiratory failure.
As compared to high-flow nasal cannula, helmet noninvasive ventilation improves oxygenation, reduces inspiratory effort, respiratory rate and dyspnea. Whether these physiological benefits are translated into improved outcome remains to be established.
The investigators designed a randomized trial to establish whether first line treatment with Helmet noninvasive ventilation is capable of increasing the number of 28-day respiratory-support-free days, as compared to high-flow nasal cannula in patients with moderate-to-severe acute hypoxemic respiratory failure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Acute-onset respiratory distress or flue-related symptoms Moderate-to-severe hypoxemia (PaO2/FiO2\<=200 mmHg) PaCO2\<45 mmHg pH\>7.30
Exclusion Criteria
- •Need for urgent endo-tracheal intubation Exacerbation of asthma or chronic obstructive pulmonary disease Documented pneumothorax Clinical diagnosis of Cardiogenic pulmonary oedema Do-not-intubate order Altered neurological status that requires immediate intubation and/or making the patient uncooperative Thoracic or abdominal surgery in the previous 7 days Recent head surgery or anatomy that prevent the application of helmet or Optiflow to patient's face
Outcomes
Primary Outcomes
Respiratory-support free days within 28 days from randomization
Time Frame: 28 days
The number of days in which patients did not receive any form of respiratory support (i.e. high-flow nasal cannula, noninvasive ventilation, invasive mechanical ventilation)
Secondary Outcomes
- In-intensive care unit mortality(90 days)
- Quality of life after recovery(1 year)
- Respiratory rate(28 days)
- In-hospital mortality(90 days)
- Invasive ventilation-free days within 60 days from randomization(60 days)
- Oxygenation(28 days)
- Dyspnea(28 days)
- Endotracheal intubation(28 days)
- Invasive ventilation-free days within 28 days from randomization(28 days)
- Carbon dioxide(28 days)
- 90-day mortality(90 days)