High Altitude Pulmonary Edema, Non-Invasive Positive Pressure Ventilation, Hypoxia
Conditions
Brief summary
Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
Detailed description
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.
Interventions
Continuous positive airway pressure delivered by face mask at 10cmH2O
DRUGNifedipine
Nifedipine 30mg, Pharmacotherapy
OTHERsupplemental oxygen
supplemental oxygen
Sponsors
Himalayan Rescue Association
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking will be done, as the CPAP device will be visible to both participants and investigators
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults (age 18-80) * Travel through Pheriche, Nepal * Diagnosis of HAPE by symptoms, vital signs, and lung ultrasound
Exclusion criteria
* History of chronic respiratory conditions (asthma, COPD, ILD) * Concomitant pneumonia or aspiration, cardiomyopathy, congestive heart failure * Kidney disease * Neurologic disorder * Cognitive disorder * Temporary altered mental status * Use of phosphodiesterase inhibitors or nifedipine prior to diagnosis of HAPE * Age under 18 or over 80 * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation | Up to 4 hours | Displayed on pulse oximeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasonographic assessment of pulmonary edema | Up to 4 hours | Quantification of B-lines |
| Subjective rating of dyspnea | Up to 4 hours | Based on Dypnea Severity Scale (DSS) |
Countries
Nepal
Contacts
Primary ContactN. Stuart Harris, MD, MFA
Backup ContactBlair A Parry
Outcome results
None listed