High Flow Nasal Cannula Therapy for Early Management of Acute Hypercapnic Cardiogenic Pulmonary Edema in the Emergency Department (preopticap)

High-flow Nasal Therapy for Early Management of Hypercapnic Respiratory Failure Due to Acute Cardiogenic Pulmonary Edema in the ED: a Prospective Observational Study

High flow nasal therapy (HFNT) has not been well evaluated for treating hypercapnia The purpose of this study is to determine whether high flow nasal therapy (HFNT) can decrease hypercapnia and improve respiratory distress parameters in Emergency Department patients with acute hypercapnic respiratory failure related to cardiogenic pulmonary edema and to compare its efficacy to that of non invasive ventilation.

Study Overview

• Status: Completed
• Conditions: Hypercapnic Respiratory Failure; Acute Cardiogenic Pulmonary Edema
• Intervention / Treatment: Device: High flow nasal therapy (HFNT) : Optiflow™; Device: Non invasive ventilation (niv)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients admitted for acute respiratory failure secondary to acute cardiogenic lung edema with hypercapnia

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Optiflow tm; High flow nasal therapy (HFNT)	Device: High flow nasal therapy (HFNT) : Optiflow™; 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; Other Names: High flow nasal oxygen; High flow nasal cannula; Optiflow™
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PaCO2 after a 1-hour treatment session	PaCO2 will be measured from standard laboratory arterial blood gas analysis performed at the end of the first 1-hour-treatment session	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood gas (PaO2, pH, SaO2)	blood gas (PaO2, pH, SaO2) measured from standard laboratory arterial blood gas analysis at the end of each 1h-ventilatory support session and throughout ventilatory support	at 1 hour
Respiratory rate	Respiratory rate, measured over 1-min as part of standard clinical assessment after each 1h ventilatory support session and throughout ventilatory support	at 1 hour
signs of increased work of breathing	signs of increased work of breathing assessed based on patient's use of accessory respiratory muscles and paradoxical abdominal movement and measured using 5-point likert scales ranging from 1 to 5. Signs of increased work of berthing will be assessed at the end of each 1h ventilatory support sessions throughout ventilatory support	at 1 hour
Dyspnea	Dyspnea recorded by the patient using a Modified Borg scale ranging from 0 to 10. Dyspnea will be measured at the end of each 1h ventilatory support sessions and throughout ventilatory support	at 1 hour
comfort	Comfort recorded by the patient using a visual analog scale from 0 to 10. Comfort will be assessed at the end of each 1h ventilatory support sessions and throughout ventilatory support	at 1 hour
Proportion of patients	Proportion of patients with a normalized PaCO2 (PaCO2 equal or lower than 45 mmHg),	at 1 hour

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Marjanovic N, Flacher A, Drouet L, Gouhinec AL, Said H, Vigneau JF, Chollet B, Lefebvre S, Sebbane M. High-Flow Nasal Cannula in Early Emergency Department Management of Acute Hypercapnic Respiratory Failure Due to Cardiogenic Pulmonary Edema. Respir Care. 2020 Sep;65(9):1241-1249. doi: 10.4187/respcare.07278. Epub 2020 Apr 14.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 30, 2016

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

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: RECHMPL18_0457

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