Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema (HCPAPvsHFNC)

Hospital Raja Permaisuri Bainun

Status: Completed

Conditions: Cardiogenic Pulmonary Edema

Treatments: Device: hCPAP versus HFNC

Study type: Interventional

Funder types: Other

Identifiers

NCT04005092

NMRR-17-1839-36966

Details and patient eligibility

About

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

Full description

Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute hypoxaemic and hypercapnic respiratory failure. The appropriate interface is necessary to provide comfort and lead to the success of NIV.

Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.

HFNC which delivers heated humidified high flow oxygen provides a good alternative to the conventional NIV in terms of comfort

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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)

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188 participants in 2 patient groups

Helmet Continuous Positive Airway Pressure(hCPAP)

Active Comparator group

Description:

Helmet CPAP produce a better physiological outcomes after 1-hour intervention

Treatment:

Device: hCPAP versus HFNC

High Flow Nasal Cannula(HFNC)

Active Comparator group

Description:

HFNC produce a better physiological outcomes after 1-hour intervention

Treatment:

Device: hCPAP versus HFNC