Clinical trial NCT02874339: High Flow Nasal Oxygen Versus VNI in Acute Hypercapnic Cardiogenic Pulmonary Edema
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Cardiogenic Pulmonary Edema
Hypercapnic Respiratory Failure
Keywords: Acute cardiogenic pulmonary
Respiratory failure
Hypercapnia
High flow nasal oxygen
Non invasive ventilation
Emergency department
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2016-08-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with a normalized PaCO2
timeFrame: 1hr of treatment
Secondary outcomes:
measure: Blood gas parameters
timeFrame: 1hr
measure: Blood gas parameters
timeFrame: 2hr
measure: Blood gas parameters
timeFrame: End of management (before discharge from ER)
measure: Patient's dypnea
timeFrame: 1hr
measure: Patient's dypnea
timeFrame: 2hr
measure: Patient's dypnea
timeFrame: End of management (before discharge from ER)
measure: Patient's comfort
timeFrame: 1hr
measure: Patient's comfort
timeFrame: 2hr
measure: Patient's comfort
timeFrame: End of management (before discharge from ER)
measure: Endotracheal intubation
timeFrame: 7 day and 1 month follow up
measure: Mortality
timeFrame: 7 day and 1 month follow up
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Mustapha Sebbane, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: