Acute Mountain Sickness Clinical Trial
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).
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04111263 -
Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude
|
N/A | |
Completed |
NCT01842906 -
Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID)
|
N/A | |
Completed |
NCT01536288 -
Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness
|
Phase 2 | |
Completed |
NCT00326703 -
Effects of Aircraft Cabin Altitude on Passenger Comfort and Discomfort
|
N/A | |
Completed |
NCT06310642 -
Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness
|
Phase 4 | |
Completed |
NCT03561675 -
Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years
|
Phase 4 | |
Completed |
NCT00559832 -
Prevention of Acute Mountain Sickness by Intermittent Hypoxia
|
N/A | |
Completed |
NCT01436383 -
Oxidative Stress in Hypobaric Hypoxia
|
N/A | |
Completed |
NCT00603122 -
Acclimatization Mechanisms During Ascent to 7500m
|
N/A | |
Completed |
NCT00627965 -
Randomized, Controlled Trial of Regular Sildenafil Citrate in the Prevention of Altitude Illness
|
Phase 4 | |
Completed |
NCT00664001 -
Anti-Oxidant Supplementation for the Prevention of Acute Mountain Sickness
|
Phase 3 | |
Not yet recruiting |
NCT06145113 -
The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness
|
N/A | |
Recruiting |
NCT05733338 -
The Effects of Intermittent Hypoxia on Acute Hypoxic Injury
|
N/A | |
Completed |
NCT01522326 -
Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness
|
N/A | |
Recruiting |
NCT06393998 -
CO2 Supplement for Treatment of Acute Mountain Sickness
|
N/A | |
Completed |
NCT03270787 -
Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness
|
Phase 1/Phase 2 | |
Completed |
NCT02811016 -
Inhaled Budesonide and Acute Mountain Sickness
|
Phase 1 | |
Recruiting |
NCT00886912 -
Training in Hypoxia to Prevent Acute Mountain Sickness
|
N/A | |
Terminated |
NCT03956472 -
Alternative Treatments in Acute Mountain Sickness
|
N/A | |
Recruiting |
NCT03621410 -
T89 in Prevention and Treatment of Acute Mountain Sickness (AMS) During Rapid Ascent
|
Phase 2 |