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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Cardiogenic Pulmonary Edema

Intervention / Treatment
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* Device: hCPAP vs fCPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema Exclusion Criteria: Age less than 18 years old Low GCS (less than 8), altered mental status Hemodynamic instability, impending cardiopulmonary arrest Use of vasopressors, inotropes Exacerbation of asthma or chronic respiratory failure Urgent need for endotracheal intubation Absence of airway protective gag reflex Elevated intracranial pressure Tracheostomy Pregnant Upper airway obstruction Injuries or surgery to head and neck less than 6 months upon presentation Claustrophobia Blind or poor vision Medico-legal related cases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: helmet CPAP<br>helmet CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema | Device: hCPAP vs fCPAP<br>* The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.<br>|
| Active Comparator: facemask CPAP<br>facemask CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema | Device: hCPAP vs fCPAP<br>* The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Rate | Respiratory rate change post intervention | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart rate change post intervention | 1 hour | 
| Partial Pressure of Arterial Oxygen Level | Partial arterial oxygen level post intervention | 1 hour | 
| Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen | Partial arterial oxygen/fraction of oxygen ratio change post intervention | 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. | 1 hour | 
| Partial Pressure of Arterial Carbon Dioxide level | Partial Pressure of Arterial Carbon Dioxide level change post intervention. | 1 hour | 
| Rate of Intubation | Intubation rate post intervention | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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helmet CPAP, facemask CPAP, pulmonary edema, non invasive ventilation