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

HIgh Flow Nasal Cannula Versus Noninvasive Ventilation for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED

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.

Study Overview

• Status: Completed
• Conditions: Cardiogenic Pulmonary Edema
• Intervention / Treatment: Device: Non invasive ventilation; Device: High-flow nasal cannula heated and humidified oxygen

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France
    • CHU Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Non invasive ventilation; Emergency and transport ventilator (Monnal T60, Airliquide, Antony, France)
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)	Device: High-flow nasal cannula heated and humidified oxygen; AirVO2 device (Fisher and Paykel, New Zealand)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate	Evolution of the respiratory rate within 60 minutes following the beginning of the treatment	60 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Study Chair: Benjamin ALOS, MD, CHU Poitiers; Principal Investigator: Nicolas MARJANOVIC, MD PHD, CHU Poitiers; Study Chair: Jérémy Guenezan, MD, CH Nord-Vienne; Study Chair: Maxime Jonchier, MD, CHU de Poitiers (Site de Montmorillon)

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Edema; Pulmonary Edema
• Other Study ID Numbers: HIPPOLYTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No