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Completed

NCT Number: NCT01794130

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Mountain Emergency Medicine, Eurac research

Bolzano, Provincia autonoma di Bolzano, 39100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Changes from baseline in RNA expression in circulating polymorphonucleated

    Time frame: at 9, 24, 72 hours and day 7

Sponsors and collaborators

Lead sponsor

Institute of Mountain Emergency Medicine

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 18, 2013
Registry last updated
Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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