Non-invasive Ventilation Versus High Flow Oxygen

Study Overview
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Brief Summary
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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
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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

Official Title
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Non-invasive Ventilation Versus High Flow Oxygen Through Nasal Cannula in Pneumonia Associated Acute Hypoxemic Respiratory Failure

Conditions
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Pneumonia-associated Acute Hypoxemic Respiratory Failure

Intervention / Treatment
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* Device: High Flow Oxygen nasal cannula
* Device: Noninvasive ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HFO<br>Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists | Device: High Flow Oxygen nasal cannula<br>* High Flow Oxygen nasal cannula<br>|
| Active Comparator: NIV/HFO<br>Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists | Device: High Flow Oxygen nasal cannula<br>* High Flow Oxygen nasal cannula<br>Device: Noninvasive ventilation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care admission | Rate of admission to Intensive Care Unit in the two arms | 30 days | 
| 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 | 
| 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 | 
| In-hospital mortality | Mortality rate in the 2 arms | 30 days | 
| New hospital admission | Rate of a new hospital admission within 30 days | 30 days | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noninvasive ventilation, High flow oxygen nasal cannula, Pneumonia, Acute hypoxemic respiratory failure