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OpenTrials
Completed

NCT Number: NCT04971213

HIgh Flow Versus NIV 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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Poitiers

Poitiers, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non invasive ventilation

Device

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

High-flow nasal cannula heated and humidified oxygen

Device

AirVO2 device (Fisher and Paykel, New Zealand)

Primary outcomes

  1. Respiratory rate

    Time frame: 60 minutes

    Evolution of the respiratory rate within 60 minutes following the beginning of the treatment

Secondary outcomes

  1. 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

  2. Arterial blood gas

    Time frame: 1 hour after the treatment beginning

    PaCO2 (mmHg), PaO2 (mmHg), pH

  3. Proportion of patients dying

    Time frame: 28 days

    Patient dying within 28 days

  4. Proportion of patients requiring invasive mechanical ventilation

    Time frame: 28 days

    Mechanical ventilation within 28 days.

  5. 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.

  6. 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

  7. ROX index

    Time frame: 15, 30, 60, 90 minutes after the treatment's beginning

    Rox Index was measured as following : (SpO2/FiO2)/RR

  8. 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.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2021
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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