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Pulmonary Function at High-Altitude
This study has been completed.
Study NCT00604227   Information provided by University of Heidelberg
First Received: January 17, 2008   Last Updated: January 29, 2008   History of Changes

January 17, 2008
January 29, 2008
July 2005
 
development of HAPE [ Time Frame: during the 48 h stay at altitude ]
Same as current
Complete list of historical versions of study NCT00604227 on ClinicalTrials.gov Archive Site
  • change of lung function parameters from low to high altitude [ Time Frame: during the 48 h stay at altitude ]
  • markers of pulmonary endothelial function [ Time Frame: during the 48 h stay at altitude ]
  • quantification of pulmonary interstitial fluid [ Time Frame: during the 48 h stay at altitude ]
Same as current
 
Pulmonary Function at High-Altitude
Interstitial Pulmonary Edema After Rapid Ascent to High Altitude (Margherita Hut, 4559 m)

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.

 
 
Interventional
Other, Open Label, Uncontrolled, Single Group Assignment
Pulmonary Edema
Other: Hypoxic Exposure
Experimental: high altitude exposure
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
34
August 2005
 

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00604227
 
M2005
University of Heidelberg
 
Principal Investigator: Christoph Dehnert, MD University Hospital Heidelberg
Principal Investigator: Marc M Berger, MD University Hospital Heidelberg
Study Director: Peter Bärtsch, MD, PhD University Hospital Heidelberg
University of Heidelberg
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP