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

Not Applicable

• Conditions: Hypercapnic Respiratory Failure; Acute Cardiogenic Pulmonary Edema
• Interventions: Device: High flow nasal oxygen therapy; Device: Non invasive ventilation

• Registration Number: NCT02874339
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

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 Timeline

• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-22
• Study Start: 2016-10-26
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-12
• Last Update Posted: 2018-06-13
• Primary Completion: 2018-10
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optiflow Group	High flow nasal oxygen therapy	High flow nasal oxygen therapy
NIV group	Non invasive ventilation	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a normalized PaCO2	1hr of treatment	(PaCO2 equal or lower than 45 mmHg)

Secondary Outcome Measures

Name	Time	Method
Mortality	7 day and 1 month follow up
Patient's dypnea	End of management (before discharge from ER)	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
Blood gas parameters	End of management (before discharge from ER)	Blood gas parameters will be measured from standard laboratory arterial blood gas analysis
Patient's comfort	End of management (before discharge from ER)	Comfort score will be recorded by the patient using a visual analog scale from 0 to 10 for comfort
Endotracheal intubation	7 day and 1 month follow up

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France