Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

Massachusetts General Hospital16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

High Altitude Pulmonary Edema Non-Invasive Positive Pressure Ventilation Hypoxia

Interventions

Non-Invasive Positive Pressure VentilationDEVICE

Continuous positive airway pressure delivered by face mask at 10cmH2O

NifedipineDRUG

Nifedipine 30mg, Pharmacotherapy

supplemental oxygenOTHER

supplemental oxygen

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Himalayan Rescue Association

Kathmandu, Nepal

RECRUITING

Outcomes

Primary Outcomes

Oxygen saturation

Displayed on pulse oximeter

Time frame: Up to 4 hours

Secondary Outcomes

Ultrasonographic assessment of pulmonary edema

Quantification of B-lines

Time frame: Up to 4 hours

Subjective rating of dyspnea

Based on Dypnea Severity Scale (DSS)

Time frame: Up to 4 hours

Central Contacts

N. Stuart Harris, MD, MFA

CONTACT

617-724-3290 nsharris@mgh.harvard.edu

Blair A Parry

CONTACT

617-724-4758 bparry@mgh.harvard.edu

Data from ClinicalTrials.gov

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