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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04014088

Enrollment

164

Registered

2019-07-10

Start date

2016-01-01

Completion date

2018-01-10

Last updated

2025-03-17

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

Conditions

Acute Cardiogenic Pulmonary Edema

Keywords

helmet CPAP, facemask CPAP, pulmonary edema, non invasive ventilation

Brief 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.

Interventions

DEVICEhCPAP vs fCPAP

The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema

Exclusion criteria

1. Age less than 18 years old 2. Low GCS (less than 8), altered mental status 3. Hemodynamic instability, impending cardiopulmonary arrest 4. Use of vasopressors, inotropes 5. Exacerbation of asthma or chronic respiratory failure 6. Urgent need for endotracheal intubation 7. Absence of airway protective gag reflex 8. Elevated intracranial pressure 9. Tracheostomy 10. Pregnant 11. Upper airway obstruction 12. Injuries or surgery to head and neck less than 6 months upon presentation 13. Claustrophobia 14. Blind or poor vision 15. Medico-legal related cases

Design outcomes

Primary

Measure	Time frame	Description
Respiratory Rate	1 hour	Respiratory rate change post intervention

Secondary

Measure	Time frame	Description
Partial Pressure of Arterial Oxygen Level	1 hour	Partial arterial oxygen level post intervention
Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen	1 hour	Partial arterial oxygen/fraction of oxygen ratio change post intervention
Heart Rate	1 hour	Heart rate change post intervention
Partial Pressure of Arterial Carbon Dioxide level	1 hour	Partial Pressure of Arterial Carbon Dioxide level change post intervention.
Rate of Intubation	1 hour	Intubation rate post intervention
Dyspnea Scale	1 hour	Dyspnea scale improvement post intervention.Dyspnea scale measured using an unmarked 100mm VAS card that had mark with I can breathe normally, at one end correspond to patients' normal baseline breathing which score 0 and on the other end I can't breathe at all, which score 100 represent the worst difficulty perceived by patients.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026