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| Name | Class |
|---|---|
| Himalayan Rescue Association | UNKNOWN |
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Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
Patients in the Everest area will assessed for evidence of acute HAPE. Subjects will be randomized and assigned to standard care options or treatment with Non-Invasive Positive Pressure Ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Treatment | Active Comparator | Continuous supplemental oxygen and nifedipine 30mg will be administered to patients. |
|
| Non-Invasive Positive Pressure Ventilation Management | Experimental | CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Invasive Positive Pressure Ventilation | Device | Continuous positive airway pressure delivered by face mask at 10cmH2O |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation | Displayed on pulse oximeter | Up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasonographic assessment of pulmonary edema | Quantification of B-lines | Up to 4 hours |
| Subjective rating of dyspnea | Based on Dypnea Severity Scale (DSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| N. Stuart Harris, MD, MFA | Contact | 617-724-3290 | nsharris@mgh.harvard.edu | |
| Blair A Parry | Contact | 617-724-4758 | bparry@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Himalayan Rescue Association | Recruiting | Kathmandu | Nepal |
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No masking will be done, as the CPAP device will be visible to both participants and investigators
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|
| Nifedipine | Drug | Nifedipine 30mg, Pharmacotherapy |
|
| supplemental oxygen | Other | supplemental oxygen |
|
| Up to 4 hours |
| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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