Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE August 22, 2016
Last Update Posted Date June 13, 2018
Study Start Date  ICMJE October 26, 2016
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2016)
Proportion of patients with a normalized PaCO2 [ Time Frame: 1hr of treatment ]
(PaCO2 equal or lower than 45 mmHg)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
  • Blood gas parameters [ Time Frame: 1hr ]
    Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
  • Blood gas parameters [ Time Frame: 2hr ]
    Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Endotracheal intubation [ Time Frame: 7 day and 1 month follow up ]
  • Mortality [ Time Frame: 7 day and 1 month follow up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2016)
  • Blood gas parameters [ Time Frame: 1h of treatment, 2hr of treatment , at 7 day and 1 month follow-up ]
  • patient's dypnea [ Time Frame: 1h of treatment, 2hr of treatment , at 7 day and 1 month follow-up ]
  • patient's comfort [ Time Frame: 1h of treatment, 2hr of treatment , at 7 day and 1 month follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Flow Nasal Oxygen Versus VNI in Acute Hypercapnic Cardiogenic Pulmonary Edema
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Cardiogenic Pulmonary Edema
  • Hypercapnic Respiratory Failure
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Optiflow Group
    High flow nasal oxygen therapy
    Intervention: Device: High flow nasal oxygen therapy
  • Active Comparator: NIV group
    Intervention: Device: Non invasive ventilation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 16, 2016)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02874339
Other Study ID Numbers  ICMJE 9675
2016-A00349-42 ( Registry Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Fisher and Paykel Healthcare
Investigators  ICMJE
Principal Investigator: Mustapha Sebbane, MD, PhD University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP