NCT04014088

Helmet CPAP vs Facemask CPAP in ACPE (hCPAP vs fCPAP)

A Randomized Controlled Trial Comparing Helmet Continuous Positive Airway Pressure (CPAP) vs Facemask CPAP for Treatment of Acute Cardiogenic Pulmonary Edema In The Emergency Department

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Hospital Raja Permaisuri Bainun · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Edema (ACPE) patients in the Emergency Department (ED) delivered by helmet CPAP (hCPAP) and facemask CPAP (fCPAP).Patients will be randomized to receive either hCPAP or fCPAP.

Detailed description

Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute cardiogenic pulmonary edema. The appropriate interface is necessary to provide comfort and lead to the success of NIV. NIV delivered via facemask had been used widely. However, it was associated with leaks and discomfort to the patient. Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.

Conditions

• Acute Cardiogenic Pulmonary Edema

Interventions

Type	Name	Description
DEVICE	hCPAP vs fCPAP	The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-31
• Completion: 2018-01-10
• First posted: 2019-07-10
• Last updated: 2025-03-17