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

Hospital Raja Permaisuri Bainun

Status: Completed

Conditions: Acute Cardiogenic Pulmonary Edema

Treatments: Device: hCPAP vs fCPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT04014088

NMRR-14-1894-21782 (IIR).

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

164 participants in 2 patient groups

helmet CPAP

Active Comparator group

Description:

helmet CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema

Treatment:

Device: hCPAP vs fCPAP

facemask CPAP

Active Comparator group

Description:

facemask CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema

Treatment:

Device: hCPAP vs fCPAP