TCTR20210413001
Not Yet Recruiting
Phase 2
asal High Flow Oxygen Versus Non Invasive Positive Pressure Ventilation in Emergency Department Patients With Cardiogenic Pulmonary Edema: A Randomized Non-inferiority Trial
Siriraj Research and Development Fund0 sites240 target enrollmentApril 13, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- acute cardiogenic pulmonary edema
- Sponsor
- Siriraj Research and Development Fund
- Enrollment
- 240
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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