Trial | NCT04288219  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    16
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 Started
Mar 01
2020
Primary Completion
Jun 30
2021
Anticipated
Study Completion
Jun 30
2021
Anticipated
Last Update
Sep 03
2020

Device Non-Invasive Positive Pressure Ventilation

Continuous positive airway pressure delivered by face mask at 10cmH2O

  • Other names: CPAP

Drug Nifedipine

Nifedipine 30mg, Pharmacotherapy

Other supplemental oxygen

supplemental oxygen

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.

Criteria 

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
No Results Posted