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

Not Applicable

Completed

• Conditions: Acute Cardiogenic Pulmonary Edema
• Interventions: Device: hCPAP vs fCPAP

• Registration Number: NCT04014088
• Lead Sponsor: Hospital Raja Permaisuri Bainun

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-01-10
• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
helmet CPAP	hCPAP vs fCPAP	helmet CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema
facemask CPAP	hCPAP vs fCPAP	facemask CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema

Primary Outcome Measures

Name	Time	Method
Respiratory Rate	1 hour	Respiratory rate change post intervention

Secondary Outcome Measures

Name	Time	Method
Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen	1 hour	Partial arterial oxygen/fraction of oxygen ratio change 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.
Heart Rate	1 hour	Heart rate change post intervention
Partial Pressure of Arterial Oxygen Level	1 hour	Partial arterial oxygen level 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