Non-invasive Ventilation Versus High Flow Oxygen
Non-invasive Ventilation Versus High Flow Oxygen Through Nasal Cannula in Pneumonia Associated Acute Hypoxemic Respiratory Failure
Niguarda Hospital
128 participants
Nov 1, 2017
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria10
- 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
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Interventions
High Flow Oxygen nasal cannula
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03758508