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Pulmonary Function at High-Altitude

NCT ID: NCT00604227

Last Updated: 2008-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Edema

Keywords

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high altitude pulmonary edema pulmonary interstitial fluid pulmonary function testing hypoxia pulmonary endothelial function high altitude exposure without prior acclimatization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

high altitude exposure

Group Type EXPERIMENTAL

Hypoxic Exposure

Intervention Type OTHER

ascent to 4559 m within 24 h without prior acclimatization

Interventions

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Hypoxic Exposure

ascent to 4559 m within 24 h without prior acclimatization

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Principal Investigators

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Christoph Dehnert, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Marc M Berger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Peter Bärtsch, MD, PhD

Role: STUDY_DIRECTOR

University Hospital Heidelberg

Locations

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Sports Medicine, University Hospital

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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M2005

Identifier Type: -

Identifier Source: org_study_id