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

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04288219
• Other study ID #: 2019P003234
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: June 2021

Study information

• Verified date: September 2020
• Source: Massachusetts General Hospital
• Contact: N. Stuart Harris, MD, MFA
• Phone: 617-724-3290
• Email: nsharris[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Altitude Sickness
• Edema
• High Altitude Pulmonary Edema
• Hypertension, Pulmonary
• Hypoxia
• Non-Invasive Positive Pressure Ventilation
• Pulmonary Edema

Intervention

Device:
• Non-Invasive Positive Pressure Ventilation
Continuous positive airway pressure delivered by face mask at 10cmH2O

Drug:
• Nifedipine
Nifedipine 30mg, Pharmacotherapy

Other:
• supplemental oxygen
supplemental oxygen

Locations

Country	Name	City	State
Nepal	Himalayan Rescue Association	Kathmandu

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Himalayan Rescue Association

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen saturation	Displayed on pulse oximeter	Up to 4 hours
Secondary	Ultrasonographic assessment of pulmonary edema	Quantification of B-lines	Up to 4 hours
Secondary	Subjective rating of dyspnea	Based on Dypnea Severity Scale (DSS)	Up to 4 hours