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

NCT ID: NCT04971213

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-22
• Study Completion Date: 2022-12-01

Brief Summary

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.

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.

Conditions

Cardiogenic Pulmonary Edema

Study Design

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

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Non invasive ventilation

Intervention Type: DEVICE

Emergency and transport ventilator (Monnal T60, Airliquide, Antony, France)

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)

Group Type: EXPERIMENTAL

High-flow nasal cannula heated and humidified oxygen

Intervention Type: DEVICE

AirVO2 device (Fisher and Paykel, New Zealand)

Interventions

Non invasive ventilation

Emergency and transport ventilator (Monnal T60, Airliquide, Antony, France)

Intervention Type: DEVICE

High-flow nasal cannula heated and humidified oxygen

AirVO2 device (Fisher and Paykel, New Zealand)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin ALOS, MD

Role: STUDY_CHAIR

CHU Poitiers

Nicolas MARJANOVIC, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Poitiers

Jérémy Guenezan, MD

Role: STUDY_CHAIR

CH Nord-Vienne

Maxime Jonchier, MD

Role: STUDY_CHAIR

CHU de Poitiers (Site de Montmorillon)

Locations

CHU Poitiers

Poitiers, , France

Countries

France

References

Marjanovic N, Piton M, Lamarre J, Alleyrat C, Couvreur R, Guenezan J, Mimoz O, Frat JP. High-flow nasal cannula oxygen versus noninvasive ventilation for the management of acute cardiogenic pulmonary edema: a randomized controlled pilot study. Eur J Emerg Med. 2024 Aug 1;31(4):267-275. doi: 10.1097/MEJ.0000000000001128. Epub 2024 Feb 16.

Reference Type: DERIVED

PMID: 38364020 (View on PubMed)

Other Identifiers

HIPPOLYTE

Identifier Type: -

Identifier Source: org_study_id