Back to resultsNon-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
Primary Purpose
High Altitude Pulmonary Edema, Non-Invasive Positive Pressure Ventilation, Hypoxia
Status
Unknown status
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Non-Invasive Positive Pressure Ventilation
Nifedipine
supplemental oxygen
Sponsored by
About this trial
This is an interventional treatment trial for High Altitude Pulmonary Edema
Eligibility 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
Sites / Locations
- Himalayan Rescue AssociationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care Treatment
Non-Invasive Positive Pressure Ventilation Management
Arm Description
Continuous supplemental oxygen and nifedipine 30mg will be administered to patients.
CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.
Outcomes
Primary Outcome Measures
Oxygen saturation
Displayed on pulse oximeter
Secondary Outcome Measures
Ultrasonographic assessment of pulmonary edema
Quantification of B-lines
Subjective rating of dyspnea
Based on Dypnea Severity Scale (DSS)
Full Information
NCT ID
NCT04288219
First Posted
February 25, 2020
Last Updated
September 1, 2020
Sponsor
Massachusetts General Hospital
Collaborators
Himalayan Rescue Association
1. Study Identification
Unique Protocol Identification Number
NCT04288219
Brief Title
Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
Official Title
Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Himalayan Rescue Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude Pulmonary Edema, Non-Invasive Positive Pressure Ventilation, Hypoxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
No masking will be done, as the CPAP device will be visible to both participants and investigators
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care Treatment
Arm Type
Active Comparator
Arm Description
Continuous supplemental oxygen and nifedipine 30mg will be administered to patients.
Arm Title
Non-Invasive Positive Pressure Ventilation Management
Arm Type
Experimental
Arm Description
CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.
Intervention Type
Device
Intervention Name(s)
Non-Invasive Positive Pressure Ventilation
Other Intervention Name(s)
CPAP
Intervention Description
Continuous positive airway pressure delivered by face mask at 10cmH2O
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
Nifedipine 30mg, Pharmacotherapy
Intervention Type
Other
Intervention Name(s)
supplemental oxygen
Intervention Description
supplemental oxygen
Primary Outcome Measure Information:
Title
Oxygen saturation
Description
Displayed on pulse oximeter
Time Frame
Up to 4 hours
Secondary Outcome Measure Information:
Title
Ultrasonographic assessment of pulmonary edema
Description
Quantification of B-lines
Time Frame
Up to 4 hours
Title
Subjective rating of dyspnea
Description
Based on Dypnea Severity Scale (DSS)
Time Frame
Up to 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
N. Stuart Harris, MD, MFA
Phone
617-724-3290
Email
nsharris@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Blair A Parry
Phone
617-724-4758
Email
bparry@mgh.harvard.edu
Facility Information:
Facility Name
Himalayan Rescue Association
City
Kathmandu
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Strickland, MD
Phone
+977 1-4440293
Email
bstrickland@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Brian M Strickland, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
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