CPAP Versus HFNO for the Treatment of Acute Hypoxemic Respiratory Failure Due to Community Acquired Pneumonia

Study Overview
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Brief Summary
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the study compares two non-invasive respiratory support modalities ie CPAP and High Flow nasal cannula oxygen for the treatment of severe hypoxemic respiratory failure attributed to Community acquired Pneumonia.

Detailed Description
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CPAP and High Flow nasal cannula oxygen are two established modalities for non-invasive respiratory support . In COVID pandemic era both CPAP and HFNO were widely used in the ward for the treatment of COVID-19 induced acute hypoxemic respiratory failure in order to prevent progression to intubation. Head to head comparison between the two modalities mentioned for the treatment of severe hypoxemic respiratory failure is not available neither in COVID pneumonia or Community acquired pneumonia (CAP).

Official Title
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CPAP Versus High Flow Nasal Cannula Oxygen for the Treatment of Patients With Community Acquired Pneumonia Induced Acute Hypoxemic Respiratory Failure in the Ward

Conditions
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Pneumonia, Respiratory Failure

Intervention / Treatment
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* Device: CPAP
* Device: HFNO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with age >18 year old. Been hospitalized with community acquired pneumonia hospitalized in common ward (not ICU) Patients should have pneumonia- pulmonary infiltrates in chest-xray and hypoxemic respiratory failure. Patients should be unable to keep: SpO2>93% with FiO2 50%, or SpO2 95% with FiO2 50% and have evidence of respiratory distress defined as Respiratory rate -RR>35/min Exclusion Criteria: Need for immediate or imminent intubation not fit for escalation of treatment: defined as intubation, mechanical ventilation and ICU support. Pregnant women Contraindication to CPAP or HFNO

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CPAP<br>When a patient needs FiO2 >50% to keep SpO2 >93%, or SpO2 >95% in case of persistent respiratory distress defined as RR>35/min, full face CPAP will be applied | Device: CPAP<br>* CPAP will be delivered with a CPAP valve with venturi flow system with full-face mask. Treatment will start with CPAP set at 10cmH2O and FiO2 60% to target a SpO2 ≥90% or PO2 ≥60mmHg and then adjusted according to SpO2, respiratory distress and clinical tolerance<br>|
| HFNO<br>When a patient needs FiO2 >50% to keep SpO2 >93%, or SpO2 >95% in case of persistent respiratory distress defined as RR>35/min, HFNO will be applied | Device: HFNO<br>* HFNO will be applied initially at maximal settings: 100% FiO2, flow rate 60 L/min and temperature 37C . Within 1 to 2 h, the HFNO settings should be titrated based on patients respiratory rate (<25-30 per minute), SpO2 (92-96%) and comfort<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days free from ventilatory support | days without support with either mechanical ventilation, HFNO, CPAP | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment failure defined | no of patients that needed intubation and invasive mechanical ventilation or died | 28 days | 
| intubation rate |  | 28 days | 
| hospital mortality |  | 28 days | 
| days under non-invasive respiratory support | days without support with HFNO or CPAP | 28 days | 
| hospital length of stay |  | 28 days | 
| Partial pressure of oxygen PaO2 change at 2h, 12h and 24h |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, HFNO