Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
164 participants
INTERVENTIONAL
2016-01-01
2018-01-10
Brief Summary
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Detailed Description
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NIV delivered via facemask had been used widely. However, it was associated with leaks and discomfort to the patient.
Helmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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helmet CPAP
helmet CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema
hCPAP vs fCPAP
The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.
facemask CPAP
facemask CPAP administer to patient diagnosed as acute cardiogenic pulmonary edema
hCPAP vs fCPAP
The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.
Interventions
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hCPAP vs fCPAP
The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
100 Years
ALL
No
Sponsors
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Hospital Raja Permaisuri Bainun
OTHER_GOV
Responsible Party
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Dr. Adi Bin Osman
Emergency Medicine Consultant
Principal Investigators
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Adi Osman
Role: PRINCIPAL_INVESTIGATOR
Emergency Department, Hospital Raja Permaisuri Bainun
Other Identifiers
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NMRR-14-1894-21782 (IIR).
Identifier Type: -
Identifier Source: org_study_id
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