Cardiogenic Pulmonary Edema
Conditions
Keywords
non invasive ventilation, pulmonary edema, high flow nasal cannula, helmet CPAP, respiratory failure, hyperaemia
Brief summary
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
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
Interventions
DEVICEhCPAP versus HFNC
The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.
Sponsors
Hospital Raja Permaisuri Bainun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate | 1 hour | Respiratory rate reduction post intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial Pressure Of Arterial Oxygen Level | 1 hour | Partial arterial oxygen level post intervention |
| Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen | 1 hour | Partial arterial oxygen/fraction of oxygen ratio improvement post intervention |
| Dyspnoea Scale | 1 hour | 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. |
| Heart Rate | 1 hour | Heart rate reduction post intervention |
| Rate Of Intubation | 1 hour | Intubation rate post intervention |
| 28-Days Mortality In Acute Cardiogenic Pulmonary Edema | 28 days | Mortality due to Acute Cardiogenic Pulmonary Edema |
| Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score | 1 hour | 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. |
Countries
Malaysia
Outcome results
None listed