Alternative Treatments in Acute Mountain Sickness
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Sponsorii
Institut de Formation et de Recherche en Médecine de Montagne
STUDIU CLINIC: NCT03956472
BioSeek: nct03956472
Cuvinte cheie
Abstract
The purpose of this research is to support a hypothesis that osteopathic manual medicine (OMM) and / or a 10 cmH2O end-expiratory pressure (PEEP) could be used in the prevention of acute mountain sickness (AMS).
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.
Datele
| Ultima verificare: | 04/30/2019 |
| Primul depus: | 11/15/2016 |
| Inscriere estimată trimisă: | 05/16/2019 |
| Prima postare: | 05/19/2019 |
| Ultima actualizare trimisă: | 05/16/2019 |
| Ultima actualizare postată: | 05/19/2019 |
| Data actuală de începere a studiului: | 06/16/2017 |
| Data estimată de finalizare primară: | 10/19/2018 |
| Data estimată de finalizare a studiului: | 07/30/2019 |
Stare sau boală
Acute Mountain Sickness
Intervenție / tratament
Procedure: Osteopathic group
Device: PEEP 10 cmH2O
Other: Fake Osteopathic protocol
Other: PEEP-Sham
Fază
-
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| Experimental: Osteopathic group LCS Drainage before altitude exposure | Procedure: Osteopathic group Osteopathic intervention improving drainage of LCS and cerebral blood flow through opitmizing veinous circulation |
| Experimental: PEEP 10 cmH2O 10 min at rest | Device: PEEP 10 cmH2O Breathing through a 10 cmH2O expiratory resistance for 10 min every 2 hours during 10h at 3842m high |
| Sham Comparator: Control group Sham PEEP and fake osteopathic protocol |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 18 Years La 18 Years |
| Sexe eligibile pentru studiu | All |
| Acceptă voluntari sănătoși | da |
| Criterii | Inclusion Criteria: - Healthy - Experienced alpinist - No previous acclimatization Exclusion Criteria: - Heart failure, respiratory failure, kidney failure - Pregnant woman |
Rezultat
Măsuri de rezultate primare
1. Changes in Lake Louise Score from baseline to altitude continuous exposure. [mesured and reported every hour during a 10 hours altitude exposure]
Signs of acute mountain sickness regarding its severity according the official Lake Louise Score.
Măsuri de rezultate secundare
1. Changes in numeric scale of well being from baseline to altitude continuous exposure. [every hour during a 10 hours altitude exposure]
Quantification of general feeling on a scale from 0 (feeling as before ascent) to 10 (worst feeling)
