Effect of High Altitude Exposure, Acclimatization and Re-exposure on Lung Water Content by Ultrasound
Primary Purpose
Effect of High Altitude
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Altitude Exposure
Sponsored by
About this trial
This is an interventional prevention trial for Effect of High Altitude
Eligibility Criteria
Inclusion Criteria:
- Born, raised and currently living <800m
- No overnight stay at altitudes > 1500m 4 weeks before the study
Exclusion Criteria:
- Previous altitude intolerance to altitude <3000m
- Pregnancy
- Health impairment, which requires regular treatment
Sites / Locations
- Switzerland
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Altitude Exposure
Arm Description
Acute high altitude exposure followed by 7 day acclimatization and reexposure after 7 days at low altitude
Outcomes
Primary Outcome Measures
ultrasound lung comets
Secondary Outcome Measures
ultrasound lung comets
Full Information
NCT ID
NCT02760186
First Posted
April 12, 2016
Last Updated
May 4, 2017
Sponsor
University of Zurich
Collaborators
University of Calgary
1. Study Identification
Unique Protocol Identification Number
NCT02760186
Brief Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Lung Water Content by Ultrasound
Official Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Lung Water Content by Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
University of Calgary
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective interventional trial in lowlanders evaluating effect of acute exposure, acclimatization and re-exposure to high altitude.
Detailed Description
Low altitude baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the Atacama large Millimeter Array (ALMA) base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period.
A second altitude sojourn cycle with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.
Measurements on study subjects will be performed at baseline (lowland, Santiago de Chile), then at 2nd day of altitude exposure and 7th day at altitude before returning to lowland; those are repeated in the second altitude sojourn cycle. Measurements will be conducted by qualified specialists using a portable ultrasound device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of High Altitude
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Altitude Exposure
Arm Type
Experimental
Arm Description
Acute high altitude exposure followed by 7 day acclimatization and reexposure after 7 days at low altitude
Intervention Type
Procedure
Intervention Name(s)
Altitude Exposure
Intervention Description
Altitude Exposure
Primary Outcome Measure Information:
Title
ultrasound lung comets
Time Frame
change from lowland baseline at 520m, day 2 and first sojourn at 5050 m, day 2
Secondary Outcome Measure Information:
Title
ultrasound lung comets
Time Frame
first sojourn at 5050 m, 7; second sojourn at 5050m, day 2, 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Born, raised and currently living <800m
No overnight stay at altitudes > 1500m 4 weeks before the study
Exclusion Criteria:
Previous altitude intolerance to altitude <3000m
Pregnancy
Health impairment, which requires regular treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University of Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
Switzerland
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Lung Water Content by Ultrasound
We'll reach out to this number within 24 hrs