NCT02874339

Brief Summary

The purpose of this study is to determine whether high flow nasal oxygen (HFNO) therapy is non inferior to non invasive ventilation (NIV) in the immediate treatment of patients with acute hypercapnic cardiogenic pulmonary edema associated with respiratory failure in the emergency department.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 26, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

1.9 years

First QC Date

July 28, 2016

Last Update Submit

June 12, 2018

Conditions

Acute Cardiogenic Pulmonary EdemaHypercapnic Respiratory Failure

Keywords

Acute cardiogenic pulmonaryRespiratory failureHypercapniaHigh flow nasal oxygenNon invasive ventilationEmergency department

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with a normalized PaCO2

    (PaCO2 equal or lower than 45 mmHg)

    1hr of treatment

Secondary Outcomes (11)

  • Blood gas parameters

    1hr

  • Blood gas parameters

    2hr

  • Blood gas parameters

    End of management (before discharge from ER)

  • Patient's dypnea

    1hr

  • Patient's dypnea

    2hr

  • +6 more secondary outcomes

Study Arms (2)

Optiflow Group

EXPERIMENTAL

High flow nasal oxygen therapy

Device: High flow nasal oxygen therapy

NIV group

ACTIVE COMPARATOR
Device: Non invasive ventilation

Interventions

High flow nasal oxygen therapyDEVICE

In the optiflow group, oxygen will be administered through a heated humidifier (Airvo 2, Fisher and Paykel healthcare) and applied through large bore binasal prongs. Initial gas flow rate will be set at of 60 l/min and adjusted to 40-50 l/min based on patient's tolerance. FiO2 will be adjusted to maintain an SpO2 ≥ 92%. Initial temperature will be set at 37° and reduced according to patient's tolerance.

Also known as: Optiflow TM
Optiflow Group
Non invasive ventilationDEVICE

In the NIV group, NIV will be delivered through a face mask connected to a ventilator with pressure support applied in a noninvasive ventilation mode. The Pressure-support level will be adjusted to obtain an expired tidal volume of 6-8 ml/kg of predicted body weight and a respiratory rate of 25-30 b/min. PEEP (range 5-10 cm of water) and FiO2 will be adjusted to maintain an SpO2 ≥92% and to patient's comfort.

NIV group

Eligibility Criteria

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

You may qualify if:

  • Asuspected diagnosis of acute pulmonary edema presenting with any of the following criteria:
  • Dyspnea (orthopnea or a worsening of dyspnea according to NYHA criteria)-Respiratory rate \>20 b/min
  • Bilateral crepitant rales at pulmonary auscultation
  • Pulmonary infiltrate on chest X-ray
  • Signs of respiratory failure or any of the following clinical, laboratory or or radiology signs:
  • Use of accessory respiratory muscles
  • Paradoxical abdominal movement
  • Cardiomegaly (cardiothoracic ratio \>0.5)
  • Hypertensive crisis
  • PaO2/FiO2 \<= 300 mmHg breathing O2\> 8L/min or PaO2 \<= 63mmHg breathing room air.
  • Hypercapnia (PaCO2\>45)

You may not qualify if:

  • Chronic respiratory disease or associated dyspnea from non cardiac origin,
  • Fever (\>38,5°), sepsis or ongoing infection,
  • Contra-indication to NIV,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Respiratory InsufficiencyHypercapniaEmergencies

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Mustapha Sebbane, MD, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustapha Sebbane, MD, PhD

CONTACT

0033(4)67337974m-sebbane@chu-montpellier.fr

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 28, 2016

First Posted

August 22, 2016

Study Start

October 26, 2016

Primary Completion

October 1, 2018

Study Completion

September 1, 2019

Last Updated

June 13, 2018

Record last verified: 2018-06

Locations

FR(1)