Clinical trial NCT03883555: High Flow Nasal Cannula Therapy for Early Management of Acute Hypercapnic Cardiogenic Pulmonary Edema in the Emergency Department
Official title: High-flow Nasal Therapy for Early Management of Hypercapnic Respiratory Failure Due to Acute Cardiogenic Pulmonary Edema in the ED: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cardiogenic Pulmonary Edema
Hypercapnic Respiratory Failure
Keywords: Acute cardiogenic pulmonary
Respiratory failure
Hypercapnia
High flow nasal oxygen
Non invasive ventilation
Emergency department
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2019-03-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients admitted for acute respiratory failure secondary to acute cardiogenic lung edema with hypercapnia

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in PaCO2 after a 1-hour treatment session
timeFrame: 1 hour
Secondary outcomes:
measure: blood gas (PaO2, pH, SaO2)
timeFrame: at 1 hour
measure: Respiratory rate
timeFrame: at 1 hour
measure: signs of increased work of breathing
timeFrame: at 1 hour
measure: Dyspnea
timeFrame: at 1 hour
measure: comfort
timeFrame: at 1 hour
measure: Proportion of patients
timeFrame: at 1 hour
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Mustapha Sebbane, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.