NCT04971213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 22, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

July 6, 2021

Last Update Submit

January 5, 2023

Conditions

Cardiogenic Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

  • Respiratory rate

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

    60 minutes

Secondary Outcomes (8)

  • Clinical paterns

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

  • Arterial blood gas

    1 hour after the treatment beginning

  • Proportion of patients dying

    28 days

  • Proportion of patients requiring invasive mechanical ventilation

    28 days

  • Comfort of patient according a numerical scale from 0 to 10

    30, 60 minutes after the treatment's beginning

  • +3 more secondary outcomes

Study Arms (2)

Non Invasive Ventilation

ACTIVE COMPARATOR

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.

Device: Non invasive ventilation

High-flow nasal cannula heated and humidified oxygen

EXPERIMENTAL

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)

Device: High-flow nasal cannula heated and humidified oxygen

Interventions

Non invasive ventilationDEVICE

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

Non Invasive Ventilation
High-flow nasal cannula heated and humidified oxygenDEVICE

AirVO2 device (Fisher and Paykel, New Zealand)

High-flow nasal cannula heated and humidified oxygen

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Poitiers

Poitiers, France

Location

Related Publications (1)

  • Marjanovic N, Piton M, Lamarre J, Alleyrat C, Couvreur R, Guenezan J, Mimoz O, Frat JP. High-flow nasal cannula oxygen versus noninvasive ventilation for the management of acute cardiogenic pulmonary edema: a randomized controlled pilot study. Eur J Emerg Med. 2024 Aug 1;31(4):267-275. doi: 10.1097/MEJ.0000000000001128. Epub 2024 Feb 16.

    PMID: 38364020DERIVED

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Benjamin ALOS, MD

    CHU Poitiers

    STUDY CHAIR

  • Nicolas MARJANOVIC, MD PhD

    CHU Poitiers

    PRINCIPAL INVESTIGATOR

  • Jérémy Guenezan, MD

    CH Nord-Vienne

    STUDY CHAIR

  • Maxime Jonchier, MD

    CHU de Poitiers (Site de Montmorillon)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 21, 2021

Study Start

September 22, 2021

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

January 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)