Pulmonary Function at High-Altitude

Pulmonary Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604227
• Other study ID #: M2005
• Status: Completed
• Phase: N/A
• First received: January 17, 2008
• Last updated: January 29, 2008
• Start date: July 2005
• Est. completion date: August 2005

Study information

• Verified date: November 2007
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pulmonary Edema

Intervention

Other:
• Hypoxic Exposure
ascent to 4559 m within 24 h without prior acclimatization

Locations

Country	Name	City	State
Germany	Sports Medicine, University Hospital	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of HAPE		during the 48 h stay at altitude
Secondary	change of lung function parameters from low to high altitude		during the 48 h stay at altitude
Secondary	markers of pulmonary endothelial function		during the 48 h stay at altitude
Secondary	quantification of pulmonary interstitial fluid		during the 48 h stay at altitude