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Exhaled Breath Profile at altitude


- candidate number15104
- NTR NumberNTR4073
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jul-2013
- Secondary IDsNL44930.058.13 C13.067
- Public TitleExhaled Breath Profile at altitude
- Scientific TitleExhaled Breath Profile in Acute Mountain Sickness, a field study.
- ACRONYMEBP at altitude
- hypothesisThere is no reliable biological marker for the diagnosis of Acute Mountain Sickness (AMS), so AMS is presently assessed with questionnaires: the Lake Louise self-report score (LLSRS) and the abbreviated Environmental Symptoms Questionnaire (ESQc). Recently Visual Analogue Scales (VAS) have been introduced to quantify AMS symptom intensity. In the present study, we propose measurements of volatile organic compounds (VOCs) in exhaled air to provide a non-invasive and objective test for diagnosing AMS, High Altitude Cerebral Edema (HACE) and High Altitude Pulmonary Edema (HAPE). VOCs can be measured with electronic nose (eNose) technology, which forms a breathprint of the different VOCs. The proposed study will assess the ability to discriminate between breathprints of healthy controls and subjects diagnosed with AMS, HACE or HAPE. We further will explore the usefulness of VAS for AMS by completing subject self assessment by expert physician AMS scoring.
- Healt Condition(s) or Problem(s) studiedAcute Mountain Sickness (AMS), High Altitude Cerebral Edema (HACE) , High Altitude Pulmonary Edema (HAPE)
- Inclusion criteriaAll subjects visiting the Capanna Regina Margherita (4554 m, Italy) willing and able to comply with the study protocol.
- Exclusion criteria1. Use of inhalation steroids.
2. Use of inhalation beta-adrenergic agonists.
3. Use of acetazolamide.
4. A course of oral corticosteroids, antibiotics or a respiratory infection within 4 weeks prior to the study.
5. LLS ≤ 3 of ESQc ≤ 0,7
6. Age < 18 years
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2013
- planned closingdate9-aug-2013
- Target number of participants140
- InterventionsN/A
- Primary outcomeAMS breathprint generating study: a specific VOC breathprint of subjects with AMS, measured during a stay in the Capanna Regina Margherita, Italy, at an altitude of 4559 meter.
Proof of concept study: A VOC breathprint of subjects with, or without AMS, measured during a stay in the Capanna Regina Margherita, Italy, at an altitude of 4559 meter.
- Secondary outcomeSpecific VOC breathprint which is associated with the development of HACE, as measured during a stay in the Capanna Regina Margherita, Italy, at an altitude of 4559 meter. Specific VOC breathprint which is associated with the development of HAPE, as measured during a stay in the Capanna Regina Margherita, Italy, at an altitude of 4559 meter.
SGVAS score that is associated with AMS diagnosis (scored by LLSRS and the ESQc). SGVAS score that is associated with specific AMS VOCs breathprints.
− Clinical measurements that are associated with AMS.
− IGVAS score that is associated with AMS diagnosis (scored by LLSRS and the ESQc).
- TimepointsAll tests will be performed on a single occasion on each subject participating in the study.
- Trial web sitehttps://www.facebook.com/DutchMedicalResearchExpedition
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. R.R. Berendsen
- CONTACT for SCIENTIFIC QUERIESMD. R.R. Berendsen
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Nederlandse Klim- en Bergsportvereniging, Institute of Sport Science, Faculty of Biology and Medicine, University of Lausanne
- PublicationsN/A
- Brief summaryThe proposed study will assess the ability to discriminate between breathprints of healthy controls and subjects diagnosed with AMS, HACE or HAPE. We further will explore the usefulness of VAS for AMS by completing subject self assessment by expert physician AMS scoring.

Subjects visiting the Capanna Regina Margherita (Italy) are recruited. These subjects are from different nationalities (for example Italian, French, Swiss, Austrian, German, Dutch, English, Spanish)
- Main changes (audit trail)
- RECORD9-jul-2013 - 29-jul-2013


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