High Flow Nasal Cannula Therapy for Early Management of Acute Hypercapnic Cardiogenic Pulmonary Edema in the Emergency Department
Keywords
Abstract
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.
Dates
| Last Verified: | 02/28/2019 |
| First Submitted: | 03/05/2019 |
| Estimated Enrollment Submitted: | 03/18/2019 |
| First Posted: | 03/20/2019 |
| Last Update Submitted: | 03/20/2019 |
| Last Update Posted: | 03/24/2019 |
| Actual Study Start Date: | 01/31/2015 |
| Estimated Primary Completion Date: | 08/31/2016 |
| Estimated Study Completion Date: | 09/29/2016 |
Condition or disease
Intervention/treatment
Device: Optiflow tm
Device: Non invasive ventilation (NIV)
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Optiflow tm High flow nasal therapy (HFNT) | Device: Optiflow tm 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 |
| 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Change in PaCO2 after a 1-hour treatment session [1 hour]
Secondary Outcome Measures
1. blood gas (PaO2, pH, SaO2) [at 1 hour]
2. Respiratory rate [at 1 hour]
3. signs of increased work of breathing [at 1 hour]
4. Dyspnea [at 1 hour]
5. comfort [at 1 hour]
6. Proportion of patients [at 1 hour]
