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

Mass General Brigham

Status: Unknown

Conditions: Non-Invasive Positive Pressure Ventilation; Hypoxia; High Altitude Pulmonary Edema

Treatments: Drug: Nifedipine; Other: supplemental oxygen; Device: Non-Invasive Positive Pressure Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT04288219

2019P003234

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Standard of Care Treatment

Active Comparator group

Description:

Continuous supplemental oxygen and nifedipine 30mg will be administered to patients.

Treatment:

Drug: Nifedipine

Other: supplemental oxygen

Non-Invasive Positive Pressure Ventilation Management

Experimental group

Description:

CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.

Treatment:

Drug: Nifedipine

Device: Non-Invasive Positive Pressure Ventilation