asal High Flow Oxygen Versus Non Invasive Positive Pressure Ventilation in Emergency Department Patients With Cardiogenic Pulmonary Edema: A Randomized Non-inferiority Trial

Phase 2

Conditions: acute cardiogenic pulmonary edema
pulmonary edema
cardiogenic pulmonary edema
heart failure

Registration Number: TCTR20210413001

Lead Sponsor: Siriraj Research and Development Fund

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending (Not yet recruiting)

Sex: All

Target Recruitment: 240

Inclusion Criteria

1.Adult patients (18 years of age and above) presenting with ACPE diagnosed by the attending ED physician by meeting all of the following criteria
-History of acute dyspnea
-Bilateral rales on physical examination
-At least one of the following signs on the initial chest radiograph: pulmonary venous congestion, cardiomegaly, and interstitial edema
2.Significant respiratory distress in need for non-invasive respiratory support measures by meeting all of the following
-Respiratory rate (RR) > 24 breaths/min
-Pulse oximetry (SpO2) < 92% when breathing at room air or arterial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) < 300 or SpO2/FiO2 < 240
-Signs of respiratory distress, e.g., accessory muscle use

Exclusion Criteria

1.Respiratory failure needing immediate endotracheal intubation, defined as RR > 35 breaths/min, SpO2 < 90% despite oxygen supplement at FiO2= 1.0, or abdominal dyssynchrony
2.Patients with cardiac or respiratory arrest
3.Patients with hemodynamic instability, defined as systolic blood pressure < 90 mmHg or mean arterial pressure < 65 mmHg with signs of poor tissue perfusion
4.Patients with altered mental status, defined as a Glasgow Coma Scale (GCS) score < 13
5.Agitated or non-cooperative patients
6.Patients contraindicated to the use of NIPPV and HFNC, i.e. at risk for aspiration, known or suspected pneumothorax
7.Patients with chronic kidney disease stage V or end-stage renal disease
8.Patients with ST-segment elevation myocardial infarction
9.Patients with do-not-intubate order
10.Patients with long-term non-invasive or invasive respiratory support
11.Patients with a tracheostomy tube
12.Pregnant patients

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intubation rate 72 hours prospectively observation

Secondary Outcome Measures

Name	Time	Method
Intolerance rate 72 hours prospectively observation,All-cause mortality 72 hours prospectively observation,Treatment failure rate (composite of intubation, intolerance, and mortality) 72 hours prospectively observation