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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00349-42 | Registry Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optiflow Group | Experimental | High flow nasal oxygen therapy |
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| NIV group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow nasal oxygen therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a normalized PaCO2 | (PaCO2 equal or lower than 45 mmHg) | 1hr of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Blood gas parameters | Blood gas parameters will be measured from standard laboratory arterial blood gas analysis | 1hr |
| Blood gas parameters | Blood gas parameters will be measured from standard laboratory arterial blood gas analysis |
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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:
Hypercapnia (PaCO2>45)
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mustapha Sebbane, MD, PhD | Contact | 0033(4)67337974 | m-sebbane@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mustapha Sebbane, MD, PhD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier University Hospital | Recruiting | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D006935 | Hypercapnia |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Non invasive ventilation | Device | 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. |
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| 2hr |
| Blood gas parameters | Blood gas parameters will be measured from standard laboratory arterial blood gas analysis | End of management (before discharge from ER) |
| Patient's dypnea | 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 | 1hr |
| Patient's dypnea | 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 | 2hr |
| Patient's dypnea | 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 | End of management (before discharge from ER) |
| Patient's comfort | Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort | 1hr |
| Patient's comfort | Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort | 2hr |
| Patient's comfort | Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort | End of management (before discharge from ER) |
| Endotracheal intubation | 7 day and 1 month follow up |
| Mortality | 7 day and 1 month follow up |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |