The Incidence of Subclinical High-altitude Pulmonary Oedema at High Altitude

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute of Mountain Emergency Medicine
ClinicalTrials.gov Identifier:
NCT01794130
First received: February 14, 2013
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

The aim of this investigation is to determine the incidence of silent interstitial pulmonary edema by chest ultrasound at moderate altitude (3905m). Secondary endpoints are to detect a suspected association with acute mountain sickness (AMS), co-morbidities and endothelial dysfunction (marker of hypoxia responses, endothelial damage and inflammation).


Condition
Acute Mountain Sickness
Subclinical High Altitude Pulmonary Edema

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Institute of Mountain Emergency Medicine:

Primary Outcome Measures:
  • Changes in the number of beta-lines in chest sonography [ Time Frame: at 0 (arrival at 3830m), 9, 24, 48 and 72 hours, and at day 7 ] [ Designated as safety issue: No ]
    as marker of subclinical pulmonary edema


Secondary Outcome Measures:
  • Changes from baseline of optic nerve sheath diameter [ Time Frame: at 0 (arrival at 3830m), 3, 9, 24, 48 and 72 hours, and at day 7 ] [ Designated as safety issue: No ]
    evaluated by optical nerve sonography

  • Changes from baseline in RNA expression in circulating polymorphonucleated [ Time Frame: at 9, 24, 72 hours and day 7 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood samples


Enrollment: 24
Study Start Date: July 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The high-altitude pulmonary edema (HAPE) is the leading cause of death from high altitude sickness. At moderate altitude (2500-4500m) the incidence (0.2-6%) may be underestimated because only clinical HAPE leads to symptoms and motivates the patient to seek medical advice. Cremona et al. [Cremona et al. Pulmonary extravascular fluid accumulation in recreational climbers: a prospective study. Lancet 2002;359:303-09] suggested that a silent interstitial pulmonary edema arises in most recreational climbers at moderate altitude. Recently, chest sonography has been shown to effectively detect pulmonary edema and quantify extravascular lung water through the sign of "ultrasound lung comets" (ULCs) originating from water-thickened interlobular septa [Lichtenstein D et al. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med;156:1640-46]. The technique requires only basic twodimensional technology and has been applied in extreme, out-of-hospital setting, showing in recreational climbers a high prevalence of clinically silent interstitial pulmonary edema at high-altitude [Pratali L et al. Frequent subclinical high-altitude pulmonary edema detected by chest sonography as ultrasound lung comets in recreational climbers. Crit Care Med 2010;38:1818-23]. However, data for moderate altitude remain scarce, despite that mountaineers are increasing in age and comorbidities and could be more prone to high altitude emergencies.

Prospective, non-randomised, observational study. Study participants are recruited from a scientific research group lead by the Ohio State University during a glaciology study on the Ortles Glacier in South Tyrol (3905m).

Patients are tested for a baseline measure, during a permanent stay on the glacier camp (3h, 9h, 24h, 48h, 72h, 7d ). Parameters include chest ultrasound, Lake Louise score, cerebral sensitive score, non-invasive haemodynamic parameters (i.e. US) and markers of hypoxia responses, endothelial damage and inflammation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy adults

Criteria

Inclusion Criteria:

  • healthy of age >18y

Exclusion Criteria:

  • cardiac failure
  • chronic kidney disease
  • chronic pulmonary disease
  • acute lung/heart/kidney/brain conditions
  • neoplastic disease
  • lack of consent
  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: NCT01794130

Locations
Italy
Institute of Mountain Emergency Medicine, Eurac research
Bolzano, Provincia autonoma di Bolzano, Italy, 39100
Sponsors and Collaborators
Institute of Mountain Emergency Medicine
Investigators
Study Director: Giacomo Strapazzon, MD Institute of Mountain Emergency Medicine, Eurac research
  More Information

No publications provided

Responsible Party: Institute of Mountain Emergency Medicine
ClinicalTrials.gov Identifier: NCT01794130     History of Changes
Other Study ID Numbers: V/4/11
Study First Received: February 14, 2013
Last Updated: February 15, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Edema
Altitude Sickness
Pulmonary Edema
Hypertension, Pulmonary
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on October 01, 2014