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

Cardiogenic Pulmonary Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971213
• Other study ID #: HIPPOLYTE
• Status: Completed
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Pulmonary Edema
• Edema
• Pulmonary Edema
• Respiratory Insufficiency

Intervention

Device:
• Non invasive ventilation
Emergency and transport ventilator (Monnal T60, Airliquide, Antony, France)
• High-flow nasal cannula heated and humidified oxygen
AirVO2 device (Fisher and Paykel, New Zealand)

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate	Evolution of the respiratory rate within 60 minutes following the beginning of the treatment	60 minutes
Secondary	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
Secondary	Arterial blood gas	PaCO2 (mmHg), PaO2 (mmHg), pH	1 hour after the treatment beginning
Secondary	Proportion of patients dying	Patient dying within 28 days	28 days
Secondary	Proportion of patients requiring invasive mechanical ventilation	Mechanical ventilation within 28 days.	28 days
Secondary	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
Secondary	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
Secondary	ROX index	Rox Index was measured as following : (SpO2/FiO2)/RR	15, 30, 60, 90 minutes after the treatment's beginning
Secondary	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