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

Hospital Raja Permaisuri Bainun164 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Acute Cardiogenic Pulmonary Edema

Interventions

hCPAP vs fCPAPDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Respiratory Rate

Respiratory rate change post intervention

Time frame: 1 hour

Secondary Outcomes

Heart Rate

Heart rate change post intervention

Time frame: 1 hour

Partial Pressure of Arterial Oxygen Level

Partial arterial oxygen level post intervention

Time frame: 1 hour

Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen

Partial arterial oxygen/fraction of oxygen ratio change post intervention

Time frame: 1 hour

Dyspnea Scale

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.

Time frame: 1 hour

Partial Pressure of Arterial Carbon Dioxide level

Partial Pressure of Arterial Carbon Dioxide level change post intervention.

Time frame: 1 hour

Rate of Intubation

Intubation rate post intervention

Time frame: 1 hour

Data from ClinicalTrials.gov

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