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

NCT03883555 | Completed

• 1 other identifier: RECHMPL18_0457
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Cardiogenic Pulmonary Edema; Hypercapnic Respiratory Failure

Keywords

Acute cardiogenic pulmonary; Respiratory failure; Hypercapnia; High flow nasal oxygen; Non invasive ventilation; Emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• blood gas (PaO2, pH, SaO2)

  at 1 hour

• Respiratory rate

  at 1 hour

• signs of increased work of breathing

  at 1 hour

• Dyspnea

  at 1 hour

• comfort

  at 1 hour

Study Arms (2)

Optiflow tm

High flow nasal therapy (HFNT)

Device: High flow nasal therapy (HFNT) : Optiflow™

Non invasive ventilation (NIV)

Non invasive ventilation (NIV)

Device: Non invasive ventilation (niv)

Interventions

High flow nasal therapy (HFNT) : Optiflow™ DEVICE

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

Also known as: High flow nasal cannula, High flow nasal oxygen, Optiflow™

Optiflow tm

Non invasive ventilation (niv) DEVICE

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.

Non invasive ventilation (NIV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 32291308 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Hypercapnia; Emergencies

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Mustapha Sebbane, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 21, 2019
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 30, 2016
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

FR (1)