CHU Poitiers
Poitiers, France
NCT Number: NCT04971213
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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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Poitiers, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Emergency and transport ventilator (Monnal T60, Airliquide, Antony, France)
AirVO2 device (Fisher and Paykel, New Zealand)
Time frame: 60 minutes
Evolution of the respiratory rate within 60 minutes following the beginning of the treatment
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
Time frame: 1 hour after the treatment beginning
PaCO2 (mmHg), PaO2 (mmHg), pH
Time frame: 28 days
Patient dying within 28 days
Time frame: 28 days
Mechanical ventilation within 28 days.
Time frame: 30, 60 minutes after the treatment's beginning
Comfort will be assessed using a numerical 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
Time frame: 15, 30, 60, 90 minutes after the treatment's beginning
Rox Index was measured as following : (SpO2/FiO2)/RR
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.
Poitiers University Hospital
Other
HIgh Flow Nasal Cannula Versus Noninvasive Ventilation for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED
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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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