NCT03883555

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Cardiogenic Pulmonary Edema
• Hypercapnic Respiratory Failure

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-09-01
• Completion: 2016-09-30
• First posted: 2019-03-21
• Last updated: 2019-03-25

Locations

1 site across 1 country: France