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CompletedNCT00604227Updated Jan 30, 2008

Pulmonary Function at High-Altitude

An interventional study of Hypoxic Exposure in Pulmonary Edema, sponsored by Heidelberg University. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-30.

Sponsored by Heidelberg University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Edema

Keywords

  • high altitude pulmonary edema
  • pulmonary interstitial fluid
  • pulmonary function testing
  • hypoxia
  • pulmonary endothelial function
  • high altitude exposure without prior acclimatization
03

In context

Pulmonary Edema

138 studies on the registry are indexed under Pulmonary Edema; 24 are open to participants now.

This study's enrollment of 34 is below the median of 68 across 72 interventional studies indexed under Pulmonary Edema.

Browse Pulmonary Edema studies →

Lead sponsor

Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    1

    high altitude exposure

    Other: Hypoxic Exposure

Interventions

  • OtherHypoxic Exposure

    ascent to 4559 m within 24 h without prior acclimatization

06

What researchers measure

Primary outcomes

  1. development of HAPE

    Time frame: during the 48 h stay at altitude

Secondary outcomes

  1. change of lung function parameters from low to high altitude

    Time frame: during the 48 h stay at altitude

  2. markers of pulmonary endothelial function

    Time frame: during the 48 h stay at altitude

  3. quantification of pulmonary interstitial fluid

    Time frame: during the 48 h stay at altitude

07

Study locations

1 site
  • Sports Medicine, University Hospital
    Heidelberg, 69120, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00604227
Lead sponsor
Heidelberg University
First posted
Jan 30, 2008
Start date
Jul 2005
Completion
Aug 2005
Last update
Jan 30, 2008

Study contacts

Christoph Dehnert, MD
principal investigator · University Hospital Heidelberg
Marc M Berger, MD
principal investigator · University Hospital Heidelberg
Peter Bärtsch, MD, PhD
study director · University Hospital Heidelberg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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