Cardiogenic Pulmonary Edema Clinical Trial
— HCPAPvsHFNCOfficial title:
Helmet Continuous Positive Airway Pressure Versus High Flow Nasal Cannula Oxygen in Acute Cardiogenic Pulmonary Oedema: A Randomized Control Trial
Verified date | January 2021 |
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 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.
Status | Completed |
Enrollment | 188 |
Est. completion date | September 30, 2018 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
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 |
---|---|---|---|
Malaysia | Emergency Department, Hospital Raja Permaisuri Bainun | Ipoh | Perak |
Lead Sponsor | Collaborator |
---|---|
Hospital Raja Permaisuri Bainun |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiratory Rate | Respiratory rate reduction post intervention | 1 hour | |
Secondary | Heart Rate | Heart rate reduction 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 improvement post intervention | 1 hour | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Rate Of Intubation | Intubation rate post intervention | 1 hour | |
Secondary | 28-Days Mortality In Acute Cardiogenic Pulmonary Edema | Mortality due to Acute Cardiogenic Pulmonary Edema | 28 days |
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