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High Flow Nasal Cannula Therapy for Early Management of Acute Hypercapnic Cardiogenic Pulmonary Edema in the Emergency Department (preopticap)

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: NCT03883555
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
High flow nasal therapy (HFNT) has not been well evaluated for treating hypercapnia The purpose of this study is to determine whether high flow nasal therapy (HFNT) can decrease hypercapnia and improve respiratory distress parameters in Emergency Department patients with acute hypercapnic respiratory failure related to cardiogenic pulmonary edema and to compare its efficacy to that of non invasive ventilation.

Condition or disease Intervention/treatment
Acute Cardiogenic Pulmonary Edema Hypercapnic Respiratory Failure Device: High flow nasal therapy (HFNT) : Optiflow™ Device: Non invasive ventilation (niv)

Detailed Description:

This is a prospective observational study conducted as a preliminary study to the randomized controlled OPTICAP trial (NCT02874339).

Prospective observational exploratory study including ED patients with a suspected diagnosis of acute hypercapnic respiratory failure related to cardiogenic pulmonary edema 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 receive a 1hr treatment session by either NIV or HFNT, depending on the attending ED physician expertise in using HFNT Repeat evaluation of arterial blood gases and respiratory parameters and dyspnea will be performed before and after treatment sessions according to current guidelines.

Improvement in PaCO2 and other respiratory parameters after 1hr treatment by HFNT will be analysed and compared to that of NIV.

Study Design
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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High-flow Nasal Therapy for Early Management of Hypercapnic Respiratory Failure Due to Acute Cardiogenic Pulmonary Edema in the ED: a Prospective Observational Study
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Optiflow tm
High flow nasal therapy (HFNT)
 Device: High flow nasal therapy (HFNT) : Optiflow™

HFNT 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 Names:
  • High flow nasal cannula
  • High flow nasal oxygen
  • Optiflow™
Non invasive ventilation (NIV)
Non invasive ventilation (NIV)
 Device: Non invasive ventilation (niv)

NIV will be delivered through a face mask connected to a dedicated ventilator with pressure support applied in a noninvasive ventilation mode (Monnal T75, Airliquide Medical Systems, Antony, France).

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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in PaCO2 after a 1-hour treatment session [ Time Frame: 1 hour ]
    PaCO2 will be measured from standard laboratory arterial blood gas analysis performed at the end of the first 1-hour-treatment session


Secondary Outcome Measures :
  1. blood gas (PaO2, pH, SaO2) [ Time Frame: at 1 hour ]
    blood gas (PaO2, pH, SaO2) measured from standard laboratory arterial blood gas analysis at the end of each 1h-ventilatory support session and throughout ventilatory support

  2. Respiratory rate [ Time Frame: at 1 hour ]
    Respiratory rate, measured over 1-min as part of standard clinical assessment after each 1h ventilatory support session and throughout ventilatory support

  3. signs of increased work of breathing [ Time Frame: at 1 hour ]
    signs of increased work of breathing assessed based on patient's use of accessory respiratory muscles and paradoxical abdominal movement and measured using 5-point likert scales ranging from 1 to 5. Signs of increased work of berthing will be assessed at the end of each 1h ventilatory support sessions throughout ventilatory support

  4. Dyspnea [ Time Frame: at 1 hour ]

    Dyspnea recorded by the patient using a Modified Borg scale ranging from 0 to 10.

    Dyspnea will be measured at the end of each 1h ventilatory support sessions and throughout ventilatory support


  5. comfort [ Time Frame: at 1 hour ]
    Comfort recorded by the patient using a visual analog scale from 0 to 10. Comfort will be assessed at the end of each 1h ventilatory support sessions and throughout ventilatory support

  6. Proportion of patients [ Time Frame: at 1 hour ]
    Proportion of patients with a normalized PaCO2 (PaCO2 equal or lower than 45 mmHg),


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients admitted for acute respiratory failure secondary to acute cardiogenic lung edema with hypercapnia
Criteria

Inclusion criteria:

a suspected diagnosis of acute cardiogenic 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 radiology signs:

  • Use of accessory respiratory muscles or 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 mmHg at arterial blood gas analysis)

Exclusion criteria:

  • acute exacerbation of chronic obstructive pulmonary disease or associated dyspnea from non cardiac origin
  • Fever (>38,5°), sepsis or ongoing infection
  • Contra-indication to NIV
Contacts and Locations
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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): NCT03883555


Locations
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France
Uhmontpellier
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03883555    
Other Study ID Numbers: RECHMPL18_0457
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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