Clinical trial NCT01794130: The Incidence of Subclinical High-altitude Pulmonary Oedema at High Altitude
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Mountain Sickness
Subclinical High Altitude Pulmonary Edema
Lead sponsor: Institute of Mountain Emergency Medicine
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: 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).

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 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

Primary outcomes:
measure: Changes in the number of beta-lines in chest sonography
timeFrame: at 0 (arrival at 3830m), 9, 24, 48 and 72 hours, and at day 7
Secondary outcomes:
measure: Changes from baseline of optic nerve sheath diameter
timeFrame: at 0 (arrival at 3830m), 3, 9, 24, 48 and 72 hours, and at day 7
measure: Changes from baseline in RNA expression in circulating polymorphonucleated
timeFrame: at 9, 24, 72 hours and day 7
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Institute of Mountain Emergency Medicine, Eurac research
state: Provincia autonoma di Bolzano
Study officials:
affiliation: Institute of Mountain Emergency Medicine, Eurac research
name: Giacomo Strapazzon, MD
role: STUDY_DIRECTOR
References: