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

University Hospital, Montpellier250 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Acute Cardiogenic Pulmonary Edema Hypercapnic Respiratory Failure

Interventions

High flow nasal oxygen therapyDEVICE

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.

Non invasive ventilationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Montpellier University Hospital

Montpellier, France

RECRUITING

Outcomes

Primary Outcomes

Proportion of patients with a normalized PaCO2

(PaCO2 equal or lower than 45 mmHg)

Time frame: 1hr of treatment

Secondary Outcomes

Blood gas parameters

Blood gas parameters will be measured from standard laboratory arterial blood gas analysis

Time frame: 1hr

Blood gas parameters

Blood gas parameters will be measured from standard laboratory arterial blood gas analysis

Time frame: 2hr

Blood gas parameters

Blood gas parameters will be measured from standard laboratory arterial blood gas analysis

Time frame: 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

Time frame: 1hr

Patient's dypnea

Time frame: 2hr

Patient's dypnea

Central Contacts

Mustapha Sebbane, MD, PhD

CONTACT

0033(4)67337974 m-sebbane@chu-montpellier.fr

Data from ClinicalTrials.gov

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