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Completed

NCT Number: NCT03883555

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

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.

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Key information

Conditions

Acute Cardiogenic Pulmonary Edema Disease Attributes Emergencies Hypercapnia Hypercapnic Respiratory Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High flow nasal therapy (HFNT) : Optiflow™

Device

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)

Device

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.

Primary outcomes

  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 outcomes

  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),

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Fisher and Paykel Healthcare

Registry information

Official study 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

Acronym: preopticap

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2019
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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