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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04971213
Study type Interventional
Source Poitiers University Hospital
Contact
Status Completed
Phase N/A
Start date September 22, 2021
Completion date December 1, 2022

See also
  Status Clinical Trial Phase
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Completed NCT04005092 - Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema N/A
Recruiting NCT06107257 - Cardiogenic Acute Pulmonary Edema in Subjects Over 75 Years Old: Impact of Non-invasive Ventilation on Mortality
Completed NCT03041428 - Ultra Protective Ventilation During Venoarterial Extracorporeal Membrane Oxygenation (UPV-ECMO) N/A
Completed NCT00390442 - Out-of-Hospital CPAP for Severe Cardiogenic Pulmonary Edema Phase 3