HIgh Flow Versus NIV for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED

Overview

The purpose of this study is to compare non invasive ventilation to high flow nasal cannula oxygen for the management of patients admitted with an acute respiratory failure due to an acute cardiogenic pulmonary edema.

Full Title of Study: “HIgh Flow Nasal Cannula Versus Noninvasive Ventilation for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 15, 2022

Detailed Description

Acute cardiogenic pulmonary oedema is a leading cause of acute respiratory distress in patients admitted in an Emergency Department. With diuretics and nitrite derivative, noninvasive ventilation is the first-line treatment of acute pulmonary oedema recommended by the European Society of Cardiology. Noninvasive ventilation is able to reduce the respiratory rate faster than standard oxygen therapy, to improve oxygenation, and some data suggest it could reduce the mortality rate. NIV may be poorly tolerated in certain patients, in whom it is associated with failure of treatment and poor outcomes. High-flow nasal cannula heated and humidified oxygen (HFNO) is a ventilatory support used in ICU and recently introduced in Emergency Departments. As compared NIV and standard oxygen therapy, HFNO reduces the mortality rate in patients with acute hypoxemic respiratory failure hospitalized in an ICU. In addition, in these patients, HFNO is also better tolerated than noninvasive ventilation. Some data suggested HFNO is superior to standard oxygen therapy in acute pulmonary oedema and could have a similar clinical effect to NIV. However, there is no research that has compared tolerance of patients admitted in an ED with acute pulmonary oedema and treated by HFNO or NIV. Included patients will be treated with NIV or HFNO. NIV will be provided with an emergency and transport ventilator (Monnal T60, Airliquide, Antony, France) and HFNO will be provided with an AirVO2 device (Fisher and Paykel, New Zealand). Patients will be treated in an Emergency Department immediately after their admission and their consent. Treatment will be provided for a minimum of one hour. Tolerance of patients will be measured under treatment using a comfort numerical scale from 0 – well comfortable to 10 extremely uncomfortable. Clinical and biological patterns will be also recorded. Patients will be followed from their inclusion to 28 days after their inclusion.

Interventions

  • Device: Non invasive ventilation
    • Emergency and transport ventilator (Monnal T60, Airliquide, Antony, France)
  • Device: High-flow nasal cannula heated and humidified oxygen
    • AirVO2 device (Fisher and Paykel, New Zealand)

Arms, Groups and Cohorts

  • Active Comparator: Non Invasive Ventilation
    • Bilevel non-invasive ventilation. Support pressure will be set to obtain a 6-8 mL/kg of predicted body weight PEEP will be set within 5-10 cmH2O and FiO2 for a SpO2 equal or over 94% target. (92% in patients with chronic respiratory failure) All settings will be adjusted according tolerance of the patient.
  • Experimental: High-flow nasal cannula heated and humidified oxygen
    • Flow will be set at 60 L/min and ajusted according the tolerance of the patient. FiO2 will be set according a SpO2 equal or over 94% target. (92% in patients with chronic respiratory failure)

Clinical Trial Outcome Measures

Primary Measures

  • Respiratory rate
    • Time Frame: 60 minutes
    • Evolution of the respiratory rate within 60 minutes following the beginning of the treatment

Secondary Measures

  • Clinical paterns
    • Time Frame: 15, 30, 60, 90 minutes after the treatment’s beginning
    • Respiratory rate in breaths/min, heart rate (beats/min), arterial blood pressure (mmHg), signs of increased work of breathing
  • Arterial blood gas
    • Time Frame: 1 hour after the treatment beginning
    • PaCO2 (mmHg), PaO2 (mmHg), pH
  • Proportion of patients dying
    • Time Frame: 28 days
    • Patient dying within 28 days
  • Proportion of patients requiring invasive mechanical ventilation
    • Time Frame: 28 days
    • Mechanical ventilation within 28 days.
  • Comfort of patient according a numerical scale from 0 to 10
    • Time Frame: 30, 60 minutes after the treatment’s beginning
    • Comfort will be assessed using a numerical scale.
  • Evolution of dyspnea according a Modified Borg Scale
    • Time Frame: 15, 30, 60, 90 minutes after the treatment’s beginning
    • Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
  • ROX index
    • Time Frame: 15, 30, 60, 90 minutes after the treatment’s beginning
    • Rox Index was measured as following : (SpO2/FiO2)/RR
  • Proportion of patients responding to the ventilatory support
    • Time Frame: 15, 30, 60, 90 minutes after the treatment’s beginning
    • Patients with a respiratory rate under or equal to 25 AND without signs of increased work of breathing.

Participating in This Clinical Trial

Inclusion Criteria

  • age over or equal 18 years old – admitted in an Emergency Department – acute respiratory failure defined by a respiratory rate over or equal 25 breathes/min or signs of increased work of breathing – clinical suspicion of acute heart failure defined bu the European Cardiologic Society. Exclusion Criteria:

  • patient requiring immediate invasive mechanical ventilation – neurologic distress defined by a Glasgow Coma Scale under 13 – haemodynamic failure defined by a Mean Blood Pressure under 65 mmHg or patient requiring catecholamines

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Poitiers University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Benjamin ALOS, MD, Study Chair, CHU Poitiers
    • Nicolas MARJANOVIC, MD PhD, Principal Investigator, CHU Poitiers
    • Jérémy Guenezan, MD, Study Chair, CH Nord-Vienne
    • Maxime Jonchier, MD, Study Chair, CHU de Poitiers (Site de Montmorillon)
  • Overall Contact(s)
    • Nicolas S MARJANOVIC, MD PHD, 0549441873, nicolas.marjanovic@chu-poitiers.fr

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