Status:
UNKNOWN
Non-invasive Ventilation Versus High Flow Oxygen
Lead Sponsor:
Niguarda Hospital
Conditions:
Pneumonia-associated Acute Hypoxemic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pneumo...
Detailed Description
Both Non Invasive Ventilation (NIV) and High Flow Oxygen through nasal cannula (HFO) are widely used in the setting of hypoxemic respiratory failure of heterogeneous etiology, with no definitive evide...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03758508
Start Date
November 1 2017
End Date
December 1 2025
Last Update
March 22 2023
Active Locations (1)
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1
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162