High Flow Oxygen nasal cannulaNoninvasive ventilation
High Flow Oxygen nasal cannula: High Flow Oxygen nasal cannula
Noninvasive ventilation: In this arm, participants receive noninvasive ventilation through an interface (such as full face mask or oro-nasal mask) alternated with continuous high flow oxygen though humidified nasal cannula
Study summary
The purpose of the study is to compare the efficacy of alternating Non Invasive Ventilation NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and prognosis in pneumonia-associated acute hypoxemic respiratory failure
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Diagnosis of pneumonia based on at least two clinical/laboratory criteria and 1 radiologic criterion among the following:
* Clinical criteria: fever, cough, purulent sputum, pulmonary examination positive for signs consistent with pneumonia
* Laboratory criteria: leukocytosis (White blood cells \>10000/mcL) or leukopenia (White blood cells \< 4000/mcL), rise of the inflammatory markers
* Radiologic criteria: consolidations at Chest X-ray or CT scan
* Hypoxemic respiratory failure, based on all the following criteria
* PaO2/FiO2 \< 300 after at least 15 minutes conventional oxygen therapy with a FiO2 ≥ 50%
* Respiratory Rate (RR) ≥ 25/min or need for use of accessory muscles
* Informed consent to study participation
Exclusion Criteria:
* Age \< 18 years
* Hypercapnic respiratory failure (pCO2 \> 60 mmHg at presentation) such as in Chronic Obstructive Pulmonary Disease
* Presence of another cause of hypoxemic respiratory failure - e.g. pulmonary embolism, acute respiratory distress syndrome (ARDS), pulmonary oedema
* Hemodynamic instability with necessity for use of inotropes and/or vasopressors
* Indication for endotracheal intubation (ETI): Glasgow Coma Scale (GCS) \<8, agitation, device intolerance, respiratory arrest
* Immunosuppression (chronic immunosuppressive therapy, clinical history positive for any immunodeficiency - congenital or acquired)
* Do Not Resuscitate (DNR) and Do Not Intubate (DNI) indication
* Tracheostomy
* Nocturnal CPAP ventilation therapy
* Any other condition which the clinician would considered an adjunctive risk for taking part in the study or that would not permit the participant to complete it
Primary outcome measure(s)
PaO2/FiO2 improvement — at baseline and at 21 hours Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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