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

University Hospital Center (CHU)

Status: Unknown

Conditions: Hypercapnic Respiratory Failure; Acute Cardiogenic Pulmonary Edema

Treatments: Device: Non invasive ventilation; Device: High flow nasal oxygen therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02874339

2016-A00349-42 (Registry Identifier)

9675

Details and patient eligibility

About

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.

Full 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).

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Optiflow Group

Experimental group

Description:

High flow nasal oxygen therapy

Treatment:

Device: High flow nasal oxygen therapy

NIV group

Active Comparator group

Treatment:

Device: Non invasive ventilation