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High Flow Nasal Oxygen Versus VNI in Acute Hypercapnic Cardiogenic Pulmonary Edema (OPTICAP)

Primary Purpose

Acute Cardiogenic Pulmonary Edema, Hypercapnic Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High flow nasal oxygen therapy
Non invasive ventilation
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cardiogenic Pulmonary Edema focused on measuring Acute cardiogenic pulmonary, Respiratory failure, Hypercapnia, High flow nasal oxygen, Non invasive ventilation, Emergency department

Eligibility Criteria

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

Inclusion criteria:

  • 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)

Exclusion criteria:

  • Chronic respiratory disease or associated dyspnea from non cardiac origin,
  • Fever (>38,5°), sepsis or ongoing infection,
  • Contra-indication to NIV,
  • Treatment with NIV or CPAP prior to inclusion, including prehospital treatment

Sites / Locations

  • Montpellier University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Optiflow Group

NIV group

Arm Description

High flow nasal oxygen therapy

Outcomes

Primary Outcome Measures

Proportion of patients with a normalized PaCO2
(PaCO2 equal or lower than 45 mmHg)

Secondary Outcome Measures

Blood gas parameters
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
Blood gas parameters
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
Blood gas parameters
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
Patient's dypnea
Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale. Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
Patient's dypnea
Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale. Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
Patient's dypnea
Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale. Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
Patient's comfort
Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort
Patient's comfort
Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort
Patient's comfort
Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort
Endotracheal intubation
Mortality

Full Information

First Posted
July 28, 2016
Last Updated
June 12, 2018
Sponsor
University Hospital, Montpellier
Collaborators
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02874339
Brief Title
High Flow Nasal Oxygen Versus VNI in Acute Hypercapnic Cardiogenic Pulmonary Edema
Acronym
OPTICAP
Official Title
High Flow Nasal Oxygen Versus VNI for Emergency Department Treatment of Acute Hypercapnic Cardiogenic Pulmonary Edema With Respiratory Failure: a Multicenter Randomized Non Inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 26, 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Prospective multicenter study including ED patients with a suspected diagnosis of acute hypercapnic pulmonary edema with respiratory failure who require NIV according to the joint recommendations from the French society of anaesthesia and intensive care and the French society for intensive care. Patients will be randomly assigned to NIV or high flow nasal oxygen therapy, with stratification on center and severity of hypercania. Assigned Treatment will be administered during at least one session of 1hr and resumed as needed based on the patient's signs of respiratory distress and blood gas results Repeat evaluation of arterial blood gases, clinical parameters and dyspnea will be performed before and after the first and second hour of treatment according to current recommendation from the French society of anesthesia and intensive care medicine (SFAR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cardiogenic Pulmonary Edema, Hypercapnic Respiratory Failure
Keywords
Acute cardiogenic pulmonary, Respiratory failure, Hypercapnia, High flow nasal oxygen, Non invasive ventilation, Emergency department

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Optiflow Group
Arm Type
Experimental
Arm Description
High flow nasal oxygen therapy
Arm Title
NIV group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
High flow nasal oxygen therapy
Other Intervention Name(s)
Optiflow TM
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Non invasive ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients with a normalized PaCO2
Description
(PaCO2 equal or lower than 45 mmHg)
Time Frame
1hr of treatment
Secondary Outcome Measure Information:
Title
Blood gas parameters
Description
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
Time Frame
1hr
Title
Blood gas parameters
Description
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
Time Frame
2hr
Title
Blood gas parameters
Description
Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
Time Frame
End of management (before discharge from ER)
Title
Patient's dypnea
Description
Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale. Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
Time Frame
1hr
Title
Patient's dypnea
Description
Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale. Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
Time Frame
2hr
Title
Patient's dypnea
Description
Dyspnea will be assessed by the emergency physician based on patient's use of accessory respiratory muscles, and measured using a 5-point likert scale. Dyspnea score will be recorded by the patient using a Modified Borg scale for dyspnea
Time Frame
End of management (before discharge from ER)
Title
Patient's comfort
Description
Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort
Time Frame
1hr
Title
Patient's comfort
Description
Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort
Time Frame
2hr
Title
Patient's comfort
Description
Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort
Time Frame
End of management (before discharge from ER)
Title
Endotracheal intubation
Time Frame
7 day and 1 month follow up
Title
Mortality
Time Frame
7 day and 1 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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) Exclusion criteria: Chronic respiratory disease or associated dyspnea from non cardiac origin, Fever (>38,5°), sepsis or ongoing infection, Contra-indication to NIV, Treatment with NIV or CPAP prior to inclusion, including prehospital treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustapha Sebbane, MD, PhD
Phone
0033(4)67337974
Email
m-sebbane@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustapha Sebbane, MD, PhD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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High Flow Nasal Oxygen Versus VNI in Acute Hypercapnic Cardiogenic Pulmonary Edema

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