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

February 14, 2013
February 15, 2013
July 2011
July 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01794130 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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The Incidence of Subclinical High-altitude Pulmonary Oedema at High Altitude
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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).

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood samples

Non-Probability Sample

Healthy adults

  • Acute Mountain Sickness
  • Subclinical High Altitude Pulmonary Edema
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01794130
V/4/11
Yes
Institute of Mountain Emergency Medicine
Institute of Mountain Emergency Medicine
Not Provided
Study Director: Giacomo Strapazzon, MD Institute of Mountain Emergency Medicine, Eurac research
Institute of Mountain Emergency Medicine
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP