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

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ClinicalTrials.gov Identifier: NCT02874339
Recruitment Status : Unknown
Verified June 2018 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : August 22, 2016
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Acute Cardiogenic Pulmonary Edema Hypercapnic Respiratory Failure Device: High flow nasal oxygen therapy Device: Non invasive ventilation Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 26, 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Optiflow Group
High flow nasal oxygen therapy
Device: High flow nasal oxygen therapy
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.
Other Name: Optiflow TM

Active Comparator: NIV group Device: Non invasive ventilation
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 Measures :
  1. Proportion of patients with a normalized PaCO2 [ Time Frame: 1hr of treatment ]
    (PaCO2 equal or lower than 45 mmHg)


Secondary Outcome Measures :
  1. Blood gas parameters [ Time Frame: 1hr ]
    Blood gas parameters will be measured from standard laboratory arterial blood gas analysis

  2. Blood gas parameters [ Time Frame: 2hr ]
    Blood gas parameters will be measured from standard laboratory arterial blood gas analysis

  3. Blood gas parameters [ Time Frame: End of management (before discharge from ER) ]
    Blood gas parameters will be measured from standard laboratory arterial blood gas analysis

  4. Patient's dypnea [ Time Frame: 1hr ]

    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


  5. Patient's dypnea [ Time Frame: 2hr ]

    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


  6. Patient's dypnea [ Time Frame: End of management (before discharge from ER) ]

    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


  7. Patient's comfort [ Time Frame: 1hr ]
    Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort

  8. Patient's comfort [ Time Frame: 2hr ]
    Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort

  9. Patient's comfort [ Time Frame: End of management (before discharge from ER) ]
    Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort

  10. Endotracheal intubation [ Time Frame: 7 day and 1 month follow up ]
  11. Mortality [ Time Frame: 7 day and 1 month follow up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874339


Contacts
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Contact: Mustapha Sebbane, MD, PhD 0033(4)67337974 m-sebbane@chu-montpellier.fr

Locations
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France
Montpellier University Hospital Recruiting
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Mustapha Sebbane, MD, PhD University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02874339    
Other Study ID Numbers: 9675
2016-A00349-42 ( Registry Identifier: ID-RCB )
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Montpellier:
Acute cardiogenic pulmonary
Respiratory failure
Hypercapnia
High flow nasal oxygen
Non invasive ventilation
Emergency department
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Edema
Edema
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Signs and Symptoms, Respiratory