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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | January 17, 2008 | ||||||||||||
| Last Updated Date | January 29, 2008 | ||||||||||||
| Start Date ICMJE | July 2005 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE |
development of HAPE [ Time Frame: during the 48 h stay at altitude ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00604227 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Pulmonary Function at High-Altitude | ||||||||||||
| Official Title ICMJE | Interstitial Pulmonary Edema After Rapid Ascent to High Altitude (Margherita Hut, 4559 m) | ||||||||||||
| 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. |
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| Detailed Description | |||||||||||||
| Study Phase | |||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Other, Open Label, Uncontrolled, Single Group Assignment | ||||||||||||
| Condition ICMJE | Pulmonary Edema | ||||||||||||
| Intervention ICMJE | Other: Hypoxic Exposure | ||||||||||||
| Study Arms / Comparison Groups | Experimental: high altitude exposure | ||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 34 | ||||||||||||
| Completion Date | August 2005 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 55 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Germany | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00604227 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | M2005 | ||||||||||||
| Study Sponsor ICMJE | University of Heidelberg | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Heidelberg | ||||||||||||
| Verification Date | November 2007 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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