Pulmonary Function at High-Altitude

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00604227

First Posted: January 30, 2008

Last Update Posted: January 30, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Heidelberg University

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: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

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
First Submitted:	January 17, 2008
First Posted:	January 30, 2008
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

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