Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
50 participants
INTERVENTIONAL
2017-06-17
2019-07-31
Brief Summary
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During altitude exposure, an exaggerated hypoxemia and the increase of intracranial pressure are both known to be major physipathological ways of AMS development.
The goal of the osteopathic protocol is to release tension on the circulatory structures directly related to cranial circulation and drainage. The main hypothesis is that it could lead to lower intracranial pressure and help reducing AMS signs. Furthermore the investigators would like to define a osteopathic score for individual AMS sensitivity, based on cranial bones mobility.
Several studies have shown that using PEEP at altitude (or hypoxia) increases SpO2. As for osteopathy protocol, the investigators would like to apply this experimental condition during real altitude exposure in a randomized controlled protocol.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Osteopathic group
LCS Drainage before altitude exposure
Osteopathic protocol for improving drainage of LCS
Osteopathic intervention improving drainage of LCS and cerebral blood flow through opitmizing veinous circulation
PEEP-Sham
PEEP 0 cmH2O (hidden)
PEEP 10 cmH2O
10 min at rest
PEEP 10cmH2O
Breathing through a 10 cmH2O expiratory resistance for 10 min every 2 hours during 10h at 3842m high
Fake Osteopathic protocol
Placebo intervention
Control group
Sham PEEP and fake osteopathic protocol
Fake Osteopathic protocol
Placebo intervention
PEEP-Sham
PEEP 0 cmH2O (hidden)
Interventions
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Osteopathic protocol for improving drainage of LCS
Osteopathic intervention improving drainage of LCS and cerebral blood flow through opitmizing veinous circulation
PEEP 10cmH2O
Breathing through a 10 cmH2O expiratory resistance for 10 min every 2 hours during 10h at 3842m high
Fake Osteopathic protocol
Placebo intervention
PEEP-Sham
PEEP 0 cmH2O (hidden)
Eligibility Criteria
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Inclusion Criteria
* Experienced alpinist
* No previous acclimatization
Exclusion Criteria
* Pregnant woman
18 Years
65 Years
ALL
Yes
Sponsors
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Institut de Formation et de Recherche en Médecine de Montagne
OTHER
Responsible Party
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Hugo Nespoulet
Head of research
Locations
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Ifremmont
Chamonix, , France
Countries
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Other Identifiers
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TAIA
Identifier Type: -
Identifier Source: org_study_id
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