High Flow Nasal Oxygen Versus VNI in Acute Hypercapnic Cardiogenic Pulmonary Edema

Study Overview
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Brief Summary
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The purpose of this study is to determine whether high flow nasal oxygen (HFNO) therapy is non inferior to non invasive ventilation (NIV) in the immediate treatment of patients with acute hypercapnic cardiogenic pulmonary edema associated with respiratory failure in the emergency department.

Detailed Description
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Prospective multicenter study including ED patients with a suspected diagnosis of acute hypercapnic pulmonary edema with respiratory failure who require NIV according to the joint recommendations from the French society of anaesthesia and intensive care and the French society for intensive care. Patients will be randomly assigned to NIV or high flow nasal oxygen therapy, with stratification on center and severity of hypercania. Assigned Treatment will be administered during at least one session of 1hr and resumed as needed based on the patient's signs of respiratory distress and blood gas results Repeat evaluation of arterial blood gases, clinical parameters and dyspnea will be performed before and after the first and second hour of treatment according to current recommendation from the French society of anesthesia and intensive care medicine (SFAR).

Official Title
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High Flow Nasal Oxygen Versus VNI for Emergency Department Treatment of Acute Hypercapnic Cardiogenic Pulmonary Edema With Respiratory Failure: a Multicenter Randomized Non Inferiority Trial

Conditions
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Acute Cardiogenic Pulmonary Edema, Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: High flow nasal oxygen therapy
* Device: Non invasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Asuspected diagnosis of acute pulmonary edema presenting with any of the following criteria: Dyspnea (orthopnea or a worsening of dyspnea according to NYHA criteria)-Respiratory rate >20 b/min Bilateral crepitant rales at pulmonary auscultation Pulmonary infiltrate on chest X-ray Signs of respiratory failure or any of the following clinical, laboratory or or radiology signs: Use of accessory respiratory muscles Paradoxical abdominal movement Cardiomegaly (cardiothoracic ratio >0.5) Hypertensive crisis PaO2/FiO2 <= 300 mmHg breathing O2> 8L/min or PaO2 <= 63mmHg breathing room air. Hypercapnia (PaCO2>45) Exclusion criteria: Chronic respiratory disease or associated dyspnea from non cardiac origin, Fever (>38,5°), sepsis or ongoing infection, Contra-indication to NIV, Treatment with NIV or CPAP prior to inclusion, including prehospital treatment

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optiflow Group<br>High flow nasal oxygen therapy | Device: High flow nasal oxygen therapy<br>* In the optiflow group, oxygen will be administered through a heated humidifier (Airvo 2, Fisher and Paykel healthcare) and applied through large bore binasal prongs. Initial gas flow rate will be set at of 60 l/min and adjusted to 40-50 l/min based on patient's tolerance. FiO2 will be adjusted to maintain an SpO2 ≥ 92%. Initial temperature will be set at 37° and reduced according to patient's tolerance.<br>* Other names: Optiflow TM;|
| Active Comparator: NIV group<br> | Device: Non invasive ventilation<br>* In the NIV group, NIV will be delivered through a face mask connected to a ventilator with pressure support applied in a noninvasive ventilation mode. The Pressure-support level will be adjusted to obtain an expired tidal volume of 6-8 ml/kg of predicted body weight and a respiratory rate of 25-30 b/min. PEEP (range 5-10 cm of water) and FiO2 will be adjusted to maintain an SpO2 ≥92% and to patient's comfort.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with a normalized PaCO2 | (PaCO2 equal or lower than 45 mmHg) | 1hr of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood gas parameters | Blood gas parameters will be measured from standard laboratory arterial blood gas analysis | 1hr | 
| Blood gas parameters | Blood gas parameters will be measured from standard laboratory arterial blood gas analysis | 2hr | 
| Blood gas parameters | Blood gas parameters will be measured from standard laboratory arterial blood gas analysis | End of management (before discharge from ER) | 
| Patient's dypnea | Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale. Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea | 1hr | 
| Patient's dypnea | Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale. Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea | 2hr | 
| Patient's dypnea | Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale. Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea | End of management (before discharge from ER) | 
| Patient's comfort | Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort | 1hr | 
| Patient's comfort | Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort | 2hr | 
| Patient's comfort | Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort | End of management (before discharge from ER) | 
| Endotracheal intubation |  | 7 day and 1 month follow up | 
| Mortality |  | 7 day and 1 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute cardiogenic pulmonary, Respiratory failure, Hypercapnia, High flow nasal oxygen, Non invasive ventilation, Emergency department