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

Primary Purpose

Cardiogenic Pulmonary Edema

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non invasive ventilation
High-flow nasal cannula heated and humidified oxygen
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Pulmonary Edema

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non Invasive Ventilation

High-flow nasal cannula heated and humidified oxygen

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical paterns
Respiratory rate in breaths/min, heart rate (beats/min), arterial blood pressure (mmHg), signs of increased work of breathing
Arterial blood gas
PaCO2 (mmHg), PaO2 (mmHg), pH
Proportion of patients dying
Patient dying within 28 days
Proportion of patients requiring invasive mechanical ventilation
Mechanical ventilation within 28 days.
Comfort of patient according a numerical scale from 0 to 10
Comfort will be assessed using a numerical scale.
Evolution of dyspnea according a Modified Borg Scale
Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
ROX index
Rox Index was measured as following : (SpO2/FiO2)/RR
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.

Full Information

First Posted
July 6, 2021
Last Updated
January 5, 2023
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04971213
Brief Title
HIgh Flow Versus NIV for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED
Official Title
HIgh Flow Nasal Cannula Versus Noninvasive Ventilation for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Pulmonary Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non Invasive Ventilation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High-flow nasal cannula heated and humidified oxygen
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Non invasive ventilation
Intervention Description
Emergency and transport ventilator (Monnal T60, Airliquide, Antony, France)
Intervention Type
Device
Intervention Name(s)
High-flow nasal cannula heated and humidified oxygen
Intervention Description
AirVO2 device (Fisher and Paykel, New Zealand)
Primary Outcome Measure Information:
Title
Respiratory rate
Description
Evolution of the respiratory rate within 60 minutes following the beginning of the treatment
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Clinical paterns
Description
Respiratory rate in breaths/min, heart rate (beats/min), arterial blood pressure (mmHg), signs of increased work of breathing
Time Frame
15, 30, 60, 90 minutes after the treatment's beginning
Title
Arterial blood gas
Description
PaCO2 (mmHg), PaO2 (mmHg), pH
Time Frame
1 hour after the treatment beginning
Title
Proportion of patients dying
Description
Patient dying within 28 days
Time Frame
28 days
Title
Proportion of patients requiring invasive mechanical ventilation
Description
Mechanical ventilation within 28 days.
Time Frame
28 days
Title
Comfort of patient according a numerical scale from 0 to 10
Description
Comfort will be assessed using a numerical scale.
Time Frame
30, 60 minutes after the treatment's beginning
Title
Evolution of dyspnea according a Modified Borg Scale
Description
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
Title
ROX index
Description
Rox Index was measured as following : (SpO2/FiO2)/RR
Time Frame
15, 30, 60, 90 minutes after the treatment's beginning
Title
Proportion of patients responding to the ventilatory support
Description
Patients with a respiratory rate under or equal to 25 AND without signs of increased work of breathing.
Time Frame
15, 30, 60, 90 minutes after the treatment's beginning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin ALOS, MD
Organizational Affiliation
CHU Poitiers
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nicolas MARJANOVIC, MD PhD
Organizational Affiliation
CHU Poitiers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jérémy Guenezan, MD
Organizational Affiliation
CH Nord-Vienne
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maxime Jonchier, MD
Organizational Affiliation
CHU de Poitiers (Site de Montmorillon)
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Poitiers
City
Poitiers
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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