The Incidence of Subclinical High-altitude Pulmonary Oedema at High Altitude
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|ClinicalTrials.gov Identifier: NCT01794130|
Recruitment Status : Completed
First Posted : February 18, 2013
Last Update Posted : February 18, 2013
|Condition or disease|
|Acute Mountain Sickness Subclinical High Altitude Pulmonary Edema|
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.
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
- 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 ]as marker of subclinical pulmonary edema
- 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 ]evaluated by optical nerve sonography
- Changes from baseline in RNA expression in circulating polymorphonucleated [ Time Frame: at 9, 24, 72 hours and day 7 ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794130
|Institute of Mountain Emergency Medicine, Eurac research|
|Bolzano, Provincia autonoma di Bolzano, Italy, 39100|
|Study Director:||Giacomo Strapazzon, MD||Institute of Mountain Emergency Medicine, Eurac research|