Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema

Hospital Raja Permaisuri Bainun188 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

188

Conditions

Cardiogenic Pulmonary Edema

Interventions

hCPAP versus HFNCDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

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

Locations (1)

Emergency Department, Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Outcomes

Primary Outcomes

Respiratory Rate

Respiratory rate reduction post intervention

Time frame: 1 hour

Secondary Outcomes

Heart Rate

Heart rate reduction 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 improvement post intervention

Time frame: 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.

Time frame: 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.

Time frame: 1 hour

Rate Of Intubation

Intubation rate post intervention

Data from ClinicalTrials.gov

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