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Pulmonary Function at High-Altitude

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ClinicalTrials.gov Identifier: NCT00604227
Recruitment Status : Completed
First Posted : January 30, 2008
Last Update Posted : January 30, 2008
Sponsor:
Information provided by:
Heidelberg University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Edema Other: Hypoxic Exposure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Interstitial Pulmonary Edema After Rapid Ascent to High Altitude (Margherita Hut, 4559 m)
Study Start Date : July 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
high altitude exposure
Other: Hypoxic Exposure
ascent to 4559 m within 24 h without prior acclimatization



Primary Outcome Measures :
  1. development of HAPE [ Time Frame: during the 48 h stay at altitude ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604227


Locations
Germany
Sports Medicine, University Hospital
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
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

ClinicalTrials.gov Identifier: NCT00604227     History of Changes
Other Study ID Numbers: M2005
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: November 2007

Keywords provided by Heidelberg University:
high altitude pulmonary edema
pulmonary interstitial fluid
pulmonary function testing
hypoxia
pulmonary endothelial function
high altitude exposure without prior acclimatization

Additional relevant MeSH terms:
Edema
Pulmonary Edema
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases