Pulmonary Function at High-Altitude

NCT00604227 | Completed

• 1 other identifier: M2005
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Edema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• development of HAPE

  during the 48 h stay at altitude

Secondary Outcomes (3)

• change of lung function parameters from low to high altitude

  during the 48 h stay at altitude

• markers of pulmonary endothelial function

  during the 48 h stay at altitude

• quantification of pulmonary interstitial fluid

  during the 48 h stay at altitude

Study Arms (1)

1

EXPERIMENTAL

high altitude exposure

Other: Hypoxic Exposure

Interventions

Hypoxic Exposure OTHER

ascent to 4559 m within 24 h without prior acclimatization

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mountaineering ability required for reaching the Margherita hut (4559 m)

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Sports Medicine, University Hospital

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Pulmonary Edema; Altitude Sickness; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoph Dehnert, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

• Marc M Berger, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

• Peter Bärtsch, MD, PhD

  University Hospital Heidelberg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 30, 2008
• Study Start: July 1, 2005
• Study Completion: August 1, 2005
• Last Updated: January 30, 2008

Record last verified: 2007-11

Locations

DE (1)