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CompletedNCT01794130Updated Feb 18, 2013

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

An observational study in Acute Mountain Sickness and Subclinical High Altitude Pulmonary Edema, sponsored by Institute of Mountain Emergency Medicine. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-18.

Sponsored by Institute of Mountain Emergency Medicine · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

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Conditions studied

  • Acute Mountain Sickness
  • Subclinical High Altitude Pulmonary Edema
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In context

Altitude Sickness

189 studies on the registry are indexed under Altitude Sickness; 44 are open to participants now.

This study's enrollment of 24 is below the median of 94 across 30 observational studies indexed under Altitude Sickness.

Browse Altitude Sickness studies →

Lead sponsor

Institute of Mountain Emergency Medicine is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy adults

Inclusion criteria

  • healthy of age >18y

Exclusion criteria

Exclusion Criteria:

  • cardiac failure
  • chronic kidney disease
  • chronic pulmonary disease
  • acute lung/heart/kidney/brain conditions
  • neoplastic disease
  • lack of consent
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
24 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Changes in the number of beta-lines in chest sonography

    as marker of subclinical pulmonary edema

    Time frame: at 0 (arrival at 3830m), 9, 24, 48 and 72 hours, and at day 7

Secondary outcomes

  1. Changes from baseline of optic nerve sheath diameter

    evaluated by optical nerve sonography

    Time frame: at 0 (arrival at 3830m), 3, 9, 24, 48 and 72 hours, and at day 7

  2. Changes from baseline in RNA expression in circulating polymorphonucleated

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

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Study locations

1 site
  • Institute of Mountain Emergency Medicine, Eurac research
    Bolzano, Provincia autonoma di Bolzano 39100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01794130
Lead sponsor
Institute of Mountain Emergency Medicine
Responsible party
Sponsor
First posted
Feb 18, 2013
Start date
Jul 2011
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Feb 18, 2013

Study contacts

Giacomo Strapazzon, MD
study director · Institute of Mountain Emergency Medicine, Eurac research

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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