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Pulmonary Function at High-Altitude

Interstitial Pulmonary Edema After Rapid Ascent to High Altitude (Margherita Hut, 4559 m)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00604227
Enrollment
34
Registered
2008-01-30
Start date
2005-07-31
Completion date
2005-08-31
Last updated
2008-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Edema

Keywords

high altitude pulmonary edema, pulmonary interstitial fluid, pulmonary function testing, hypoxia, pulmonary endothelial function, high altitude exposure without prior acclimatization

Brief summary

Based on the findings of decreased vital capacity, decreased FEV1 and increased closing volume after ascent to high altitude, some investigators suggest the presence of a subclinical high altitude pulmonary edema (HAPE). Since these parameters are only indirect measures of pulmonary interstitial fluid accumulation, the aim of this study is to examine the effects of broncho-constriction on the increase of closing volume by extensive lung function testing in healthy mountaineers at low altitude and on the Margherita Hut (4559 m). As has been done in earlier studies, conventional thorax radiographs are used for verification of HAPE. In this study, the determination of the thoracic fluid quantity will be completed by measurements of thoracic impedance. In addition markers of pulmonary endothelial function will be assessed to get further insight into the regulation of pulmonary vascular tone at altitude and in particular into the pathophysiology of HAPE.

Interventions

ascent to 4559 m within 24 h without prior acclimatization

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Mountaineering ability required for reaching the Margherita hut (4559 m)

Exclusion criteria

* Borne above 1500 m * Subjects with internal medical diseases like all cardiac diseases, all pulmonary diseases, Diabetes mellitus, infectious diseases, thyroid diseases, malignant diseases, hepatic or renal diseases, * (Known) hypersensitivity to salbutamol or to another component of sultanol® or lidocaine, or to another component of xylocain® pump spray * Intake of drugs, especially nifedipine, acetazolamide and glucocorticoids or of drugs interacting with sultanol® or xylocain® pump spray * Pregnancy

Design outcomes

Primary

MeasureTime frame
development of HAPEduring the 48 h stay at altitude

Secondary

MeasureTime frame
change of lung function parameters from low to high altitudeduring the 48 h stay at altitude
markers of pulmonary endothelial functionduring the 48 h stay at altitude
quantification of pulmonary interstitial fluidduring the 48 h stay at altitude

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026