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

Last updated: June 12, 2018
Sponsor: University Hospital, Montpellier
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Lung Disease

Respiratory Failure

Treatment

N/A

Clinical Study ID

NCT02874339
9675
2016-A00349-42
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Asuspected diagnosis of acute pulmonary edema presenting with any of the followingcriteria:

  • Dyspnea (orthopnea or a worsening of dyspnea according to NYHA criteria)-Respiratoryrate >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 orradiology 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

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

Study Design

Total Participants: 250
Study Start date:
October 26, 2016
Estimated Completion Date:
September 30, 2019

Study 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).

Connect with a study center

  • Montpellier University Hospital

    Montpellier, 34295
    France

    Active - Recruiting

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