Acute Cardiogenic Pulmonary Edema Clinical Trial
Official title:
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
Verified date | July 2019 |
Source | Hospital Raja Permaisuri Bainun |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 164 |
Est. completion date | January 10, 2018 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital Raja Permaisuri Bainun |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiratory Rate | Respiratory rate change post intervention | 1 hour | |
Secondary | Heart Rate | Heart rate change post intervention | 1 hour | |
Secondary | Partial Pressure of Arterial Oxygen Level | Partial arterial oxygen level post intervention | 1 hour | |
Secondary | Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen | Partial arterial oxygen/fraction of oxygen ratio change post intervention | 1 hour | |
Secondary | 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 | |
Secondary | Partial Pressure of Arterial Carbon Dioxide level | Partial Pressure of Arterial Carbon Dioxide level change post intervention. | 1 hour | |
Secondary | Rate of Intubation | Intubation rate post intervention | 1 hour |
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