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

Acute Mountain Sickness Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794130
• Other study ID #: V/4/11
• Status: Completed
• Phase: N/A
• First received: February 14, 2013
• Last updated: February 15, 2013
• Start date: July 2011
• Est. completion date: July 2011

Study information

• Verified date: February 2013
• Source: Institute of Mountain Emergency Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness
• Hypertension, Pulmonary
• Pulmonary Edema
• Subclinical High Altitude Pulmonary Edema

Locations

Country	Name	City	State
Italy	Institute of Mountain Emergency Medicine, Eurac research	Bolzano	Provincia autonoma di Bolzano

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Mountain Emergency Medicine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the number of beta-lines in chest sonography	as marker of subclinical pulmonary edema	at 0 (arrival at 3830m), 9, 24, 48 and 72 hours, and at day 7	No
Secondary	Changes from baseline of optic nerve sheath diameter	evaluated by optical nerve sonography	at 0 (arrival at 3830m), 3, 9, 24, 48 and 72 hours, and at day 7	No
Secondary	Changes from baseline in RNA expression in circulating polymorphonucleated		at 9, 24, 72 hours and day 7	No