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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helmet Continuous Positive Airway Pressure(hCPAP) | Active Comparator | Helmet CPAP produce a better physiological outcomes after 1-hour intervention |
|
| High Flow Nasal Cannula(HFNC) | Active Comparator | HFNC produce a better physiological outcomes after 1-hour intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hCPAP versus HFNC | Device | The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate | Respiratory rate reduction post intervention | 1 hour |
| 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 |
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Inclusion Criteria:
All patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ADI OSMAN | EMERGENCY DEPARTMENT, HOSPITAL RAJA PERMAISURI BAINUN, IPOH, PERAK, MALAYSIA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department, Hospital Raja Permaisuri Bainun | Ipoh | Perak | 30450 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34632507 | Derived | Osman A, Via G, Sallehuddin RM, Ahmad AH, Fei SK, Azil A, Mojoli F, Fong CP, Tavazzi G. Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1103-1111. doi: 10.1093/ehjacc/zuab078. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2019 | Nov 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011654 | Pulmonary Edema |
| D012131 | Respiratory Insufficiency |
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D014652 | Vascular Diseases |
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| 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 |
| D002318 |
| Cardiovascular Diseases |