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

NCT ID: NCT02874339

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-26
• Study Completion Date: 2019-09-30

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).

Conditions

Acute Cardiogenic Pulmonary Edema; Hypercapnic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optiflow Group

High flow nasal oxygen therapy

Group Type: EXPERIMENTAL

High flow nasal oxygen therapy

Intervention Type: DEVICE

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.

NIV group

Group Type: ACTIVE_COMPARATOR

Non invasive ventilation

Intervention Type: DEVICE

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.

Interventions

High flow nasal oxygen therapy

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.

Intervention Type: DEVICE

Non invasive ventilation

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.

Intervention Type: DEVICE

Other Intervention Names

Optiflow TM

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mustapha Sebbane, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Montpellier University Hospital

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mustapha Sebbane, MD, PhD

Role: CONTACT

m-sebbane@chu-montpellier.fr

0033(4)67337974

Other Identifiers

2016-A00349-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

9675

Identifier Type: -

Identifier Source: org_study_id