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Completed

NCT Number: NCT00604227

Pulmonary Function at High-Altitude

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.

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Key information

Conditions

Pulmonary Edema Altitude Sickness Hypoxia Lung Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sports Medicine, University Hospital

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoxic exposure

Other

ascent to 4559 m within 24 h without prior acclimatization

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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Jan 30, 2008
Registry last updated
Jan 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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