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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypercapnic Respiratory Failure; Acute Cardiogenic Pulmonary Edema
• Intervention / Treatment: Device: High flow nasal oxygen therapy; Device: Non invasive ventilation

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustapha Sebbane, MD, PhD; Phone Number: 0033(4)67337974; Email: m-sebbane@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Montpellier University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optiflow Group; High flow nasal oxygen therapy	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.; Other Names: Optiflow TM
Active Comparator: NIV group	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a normalized PaCO2	(PaCO2 equal or lower than 45 mmHg)	1hr of treatment

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Mustapha Sebbane, MD, PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: October 26, 2016
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 22, 2016

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Acute cardiogenic pulmonary; Respiratory failure; Hypercapnia; High flow nasal oxygen; Non invasive ventilation; Emergency department
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Edema; Pulmonary Edema; Hypercapnia
• Other Study ID Numbers: 9675; 2016-A00349-42 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No