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

Not Applicable

• Conditions: High Altitude Pulmonary Edema; Non-Invasive Positive Pressure Ventilation; Hypoxia
• Interventions: Device: Non-Invasive Positive Pressure Ventilation; Drug: Nifedipine; Other: supplemental oxygen

• Registration Number: NCT04288219
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Study Start: 2020-03-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-Invasive Positive Pressure Ventilation Management	Non-Invasive Positive Pressure Ventilation	CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.
Standard of Care Treatment	supplemental oxygen	Continuous supplemental oxygen and nifedipine 30mg will be administered to patients.
Standard of Care Treatment	Nifedipine	Continuous supplemental oxygen and nifedipine 30mg will be administered to patients.
Non-Invasive Positive Pressure Ventilation Management	Nifedipine	CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.

Primary Outcome Measures

Name	Time	Method
Oxygen saturation	Up to 4 hours	Displayed on pulse oximeter

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Himalayan Rescue Association; 🇳🇵 Kathmandu, Nepal