Pulmonary Function at High-Altitude - Full Text View

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


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

Resource links provided by NLM:

MedlinePlus related topics: Edema

Genetic and Rare Diseases Information Center resources: Acute Mountain Sickness Pulmonary Edema of Mountaineers

U.S. FDA Resources

Further study details as provided by Heidelberg University:

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
Experimental: 1 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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Germany
Sports Medicine, University Hospital
Heidelberg, Germany, 69120

Sponsors and Collaborators

Heidelberg University

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


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

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

ClinicalTrials.gov processed this record on September 27, 2016