Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
1 other identifier
interventional
16
1 country
1
Brief Summary
Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedSeptember 3, 2020
September 1, 2020
1.3 years
February 25, 2020
September 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Oxygen saturation
Displayed on pulse oximeter
Up to 4 hours
Secondary Outcomes (2)
Ultrasonographic assessment of pulmonary edema
Up to 4 hours
Subjective rating of dyspnea
Up to 4 hours
Study Arms (2)
Standard of Care Treatment
ACTIVE COMPARATORContinuous supplemental oxygen and nifedipine 30mg will be administered to patients.
Non-Invasive Positive Pressure Ventilation Management
EXPERIMENTALCPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.
Interventions
Continuous positive airway pressure delivered by face mask at 10cmH2O
Nifedipine 30mg, Pharmacotherapy
Eligibility Criteria
You may qualify if:
- Healthy adults (age 18-80)
- Travel through Pheriche, Nepal
- Diagnosis of HAPE by symptoms, vital signs, and lung ultrasound
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Himalayan Rescue Associationcollaborator
Study Sites (1)
Himalayan Rescue Association
Kathmandu, Nepal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking will be done, as the CPAP device will be visible to both participants and investigators
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Division of Wilderness Medicine, Principal Investigator, Clinical Innstructor
Study Record Dates
First Submitted
February 25, 2020
First Posted
February 28, 2020
Study Start
March 1, 2020
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
September 3, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share