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
|
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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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
high altitude exposure
|
Other: Hypoxic Exposure
ascent to 4559 m within 24 h without prior acclimatization
|
- development of HAPE [ Time Frame: during the 48 h stay at altitude ]
- 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 ]

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

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
Germany | |
Sports Medicine, University Hospital | |
Heidelberg, Germany, 69120 |
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 |