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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01794130
Enrollment
24
Registered
2013-02-18
Start date
2011-07-31
Completion date
2011-07-31
Last updated
2013-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Mountain Sickness, Subclinical High Altitude Pulmonary Edema

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.

Interventions

None listed

Sponsors

Institute of Mountain Emergency Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in the number of beta-lines in chest sonographyat 0 (arrival at 3830m), 9, 24, 48 and 72 hours, and at day 7as marker of subclinical pulmonary edema

Secondary

MeasureTime frameDescription
Changes from baseline of optic nerve sheath diameterat 0 (arrival at 3830m), 3, 9, 24, 48 and 72 hours, and at day 7evaluated by optical nerve sonography
Changes from baseline in RNA expression in circulating polymorphonucleatedat 9, 24, 72 hours and day 7

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026