Overview

This trial is active, not recruiting.

Condition effect of high altitude
Treatment altitude exposure
Sponsor University of Zurich
Collaborator University of Calgary
Start date March 2016
End date December 2016
Trial size 21 participants
Trial identifier NCT02760186, REB15-2709_V5

Summary

Prospective interventional trial in lowlanders evaluating effect of acute exposure, acclimatization and re-exposure to high altitude.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Acute high altitude exposure followed by 7 day acclimatization and reexposure after 7 days at low altitude
altitude exposure
Altitude Exposure

Primary Outcomes

Measure
ultrasound lung comets
time frame: change from lowland baseline at 520m, day 2 and first sojourn at 5050 m, day 2

Secondary Outcomes

Measure
ultrasound lung comets
time frame: first sojourn at 5050 m, 7; second sojourn at 5050m, day 2, 7

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Effect of High Altitude Exposure, Acclimatization and Re-exposure on Lung Water Content by Ultrasound
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Zurich.