Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210413001
Enrollment
240
Registered
2021-04-13
Start date
2022-05-05
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute cardiogenic pulmonary edema pulmonary edema cardiogenic pulmonary edema heart failure

Interventions

High flow oxygen will be delivered by a specialized cannula using an AIRVO flow source (Fisher &amp
Paykel Healthcare Ltd). The initial flow will be set at 35 L/min and can be increased up to 60 L/min as tolerated by the participants. FiO2 will be adjusted to keep SpO2 94-98% and maintain there for
Experimental Device,Active Comparator Device
High-flow nasal cannula,Non-invasive positive pressure ventilation

Sponsors

Siriraj Research and Development Fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Intubation rate 72 hours prospectively observation

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactOnlak Ruangsomboon

Department of Emergency Medicine, Siriraj Hospital, Mahidol University

doctor.mo@yahoo.com0877853385

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026