Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema

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 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.

Detailed Description
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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

Official Title
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Helmet Continuous Positive Airway Pressure Versus High Flow Nasal Cannula Oxygen in Acute Cardiogenic Pulmonary Oedema: A Randomized Control Trial

Conditions
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Cardiogenic Pulmonary Edema

Intervention / Treatment
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* Device: hCPAP versus HFNC


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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Accepts Healthy Volunteers

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 Continuous Positive Airway Pressure(hCPAP)<br>Helmet CPAP produce a better physiological outcomes after 1-hour intervention | Device: hCPAP versus HFNC<br>* The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.<br>|
| Active Comparator: High Flow Nasal Cannula(HFNC)<br>HFNC produce a better physiological outcomes after 1-hour intervention | Device: hCPAP versus HFNC<br>* The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart rate reduction 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 improvement post intervention | 1 hour | 
| Dyspnoea Scale | Dyspnoea scale improvement post intervention.Dyspnea scale measured using an unmarked 10cm 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 10 represent the worst difficulty perceived by patients. | 1 hour | 
| Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score | Heart rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) and Respiratory rate(HACOR) Score improvement post intervention.HACOR is an acronym for heart rate, acidosis (pH), consciousness (GCS), oxygenation (PF ratio) and respiratory rate in which each parameter is an independent predictor for NIV failure. HACOR score is out of 25 with differential weighting of each parameter. | 1 hour | 
| Rate Of Intubation | Intubation rate post intervention | 1 hour | 
| 28-Days Mortality In Acute Cardiogenic Pulmonary Edema | Mortality due to Acute Cardiogenic Pulmonary Edema | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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helmet CPAP, non invasive ventilation, pulmonary edema, high flow nasal cannula, respiratory failure, hyperaemia