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

Hypercapnic Respiratory Failure Clinical Trial

— OPTICAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02874339
• Other study ID #: 9675
• Secondary ID: 2016-A00349-42
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2016
• Est. completion date: September 2019

Study information

• Verified date: June 2018
• Source: University Hospital, Montpellier
• Contact: Mustapha Sebbane, MD, PhD
• Phone: 0033(4)67337974
• Email: m-sebbane[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cardiogenic Pulmonary Edema
• Edema
• Hypercapnia
• Hypercapnic Respiratory Failure
• Pulmonary Edema
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Fisher and Paykel Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a normalized PaCO2	(PaCO2 equal or lower than 45 mmHg)	1hr of treatment
Secondary	Blood gas parameters	Blood gas parameters will be measured from standard laboratory arterial blood gas analysis	1hr
Secondary	Blood gas parameters	Blood gas parameters will be measured from standard laboratory arterial blood gas analysis	2hr
Secondary	Blood gas parameters	Blood gas parameters will be measured from standard laboratory arterial blood gas analysis	End of management (before discharge from ER)
Secondary	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
Secondary	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
Secondary	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)
Secondary	Patient's comfort	Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort	1hr
Secondary	Patient's comfort	Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort	2hr
Secondary	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)
Secondary	Endotracheal intubation		7 day and 1 month follow up
Secondary	Mortality		7 day and 1 month follow up