Pneumonia-associated Acute Hypoxemic Respiratory Failure
Conditions
Keywords
Noninvasive ventilation, High flow oxygen nasal cannula, Pneumonia, Acute hypoxemic respiratory failure
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 pneumonia-associated acute hypoxemic respiratory failure
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 evidence for the superiority of one technique on the other. The purpose of this study is to determine whether alternating NIV and HFO brings any advantage on gas exchanges and prognosis compared to the use of HFO alone in the homogeneous setting of pneumonia-associated acute hypoxemic respiratory failure
Interventions
High Flow Oxygen nasal cannula
DEVICENoninvasive 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
Sponsors
Niguarda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care admission | 30 days | Rate of admission to Intensive Care Unit in the two arms |
| Sensation of device comfort and dyspnoea | Baseline, at 21 hours, 45 hours and 30 days after beginning treatment. Optional measures can be taken at 1, 3 and 9 hours | Evaluation of subjective sensation of device comfort and dyspnoea in the two arms |
| Time to downgrade to conventional oxygen therapy | 30 days | Total amount of hours in which the patient needs to be treated with noninvasive ventilation alternate to versus high flow oxygen through nasal cannula |
| In-hospital mortality | 30 days | Mortality rate in the 2 arms |
| New hospital admission | 30 days | Rate of a new hospital admission within 30 days |
| PaO2/FiO2 improvement | at baseline and at 45 hours | 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 |
Countries
Italy
Contacts
CONTACTAndrea Bellone, MD
Outcome results
None listed