Pulmonary Function at High-Altitude - Full Text View

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00604227

Purpose

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	Intervention
Pulmonary Edema	Other: Hypoxic Exposure

MedlinePlus related topics: Edema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment
Official Title:	Interstitial Pulmonary Edema After Rapid Ascent to High Altitude (Margherita Hut, 4559 m)

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

development of HAPE [ Time Frame: during the 48 h stay at altitude ]

Secondary Outcome Measures:

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 ]

Enrollment:	34
Study Start Date:	July 2005
Study Completion Date:	August 2005

Arms	Assigned Interventions
1: Experimental high altitude exposure	Other: Hypoxic Exposure ascent to 4559 m within 24 h without prior acclimatization

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604227

Locations

Germany
Sports Medicine, University Hospital
Heidelberg, Germany, 69120

Sponsors and Collaborators

University of Heidelberg

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

More Information

Study ID Numbers:	M2005
Study First Received:	January 17, 2008
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00604227
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Heidelberg:

high altitude pulmonary edema
pulmonary interstitial fluid
pulmonary function testing

hypoxia
pulmonary endothelial function
high altitude exposure without prior acclimatization

Study placed in the following topic categories:

Signs and Symptoms
Altitude Sickness
Pulmonary Edema
Respiratory Tract Diseases

Pulmonary edema of mountaineers
Acute mountain sickness
Lung Diseases
Edema

ClinicalTrials.gov processed this record on January 14, 2009