Pneumonia-associated Acute Hypoxemic Respiratory Failure Clinical Trial
— HFOOfficial title:
Non-invasive Ventilation Versus High Flow Oxygen Through Nasal Cannula in Pneumonia Associated Acute Hypoxemic Respiratory Failure
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
| Status | Recruiting |
| Enrollment | 128 |
| Est. completion date | December 1, 2025 |
| Est. primary completion date | November 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | ASST Grande Ospedale Metropolitano Niguarda | Milano |
| Lead Sponsor | Collaborator |
|---|---|
| Niguarda Hospital |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PaO2/FiO2 improvement | 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 | at baseline and at 21 hours | |
| Secondary | Intensive Care admission | Rate of admission to Intensive Care Unit in the two arms | 30 days | |
| Secondary | Sensation of device comfort and dyspnoea | Evaluation of subjective sensation of device comfort and dyspnoea in the two arms | Baseline, at 21 hours, 45 hours and 30 days after beginning treatment. Optional measures can be taken at 1, 3 and 9 hours | |
| Secondary | Time to downgrade to conventional oxygen therapy | Total amount of hours in which the patient needs to be treated with noninvasive ventilation alternate to versus high flow oxygen through nasal cannula | 30 days | |
| Secondary | In-hospital mortality | Mortality rate in the 2 arms | 30 days | |
| Secondary | New hospital admission | Rate of a new hospital admission within 30 days | 30 days | |
| Secondary | PaO2/FiO2 improvement | Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 45 hours compared to baseline PaO2/FiO2 | at baseline and at 45 hours | |
| Secondary | PaO2/FiO2 improvement | Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 30 hours compared to baseline PaO2/FiO2 | at baseline and at 30 days |