Inflammatory and Cerebrospinal Biochemical Markers in Blood After Trimix Diving
TriMix17-18
Biokemiska förändringar Vid förhöjt Partialtryck för Syrgas
1 other identifier
observational
10
1 country
1
Brief Summary
Research hypothesis
- Diving to depths up to 90msw with an oxygen partial pressure of 130kPa in the breathing gas will affect the central nervous system.
- Diving to depths up to 90msw with an oxygen partial pressure of 130kPa in the breathing gas will induce inflammatory changes. Objectives:
- To investigate the presence of cerebrospinal biochemical markers in blood after diving to depths up to 90msw with an oxygen partial pressure of 130kPa in the breathing gas.
- To investigate the presence of inflammatory markers in blood after diving to depths up to 90msw with an oxygen partial pressure of 130kPa in the breathing gas.
- To investigate the presence of venous gas emboli (VGE) in blood after diving to depths up to 90msw with an oxygen partial pressure of 130kPa in the breathing gas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2017
CompletedFirst Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2019
CompletedMarch 12, 2019
March 1, 2019
1.6 years
June 14, 2017
March 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentration of cerebrospinal and inflammatory biochemical markers in blood
E.g. GFAP, Tau, NfL, JCHL-1, VCAM-1, ICAM-1
Three months
Secondary Outcomes (2)
Presence of Venous Gas Emboli (VGE)
Five days
Decompression Sickness (DCS)
Five days
Study Arms (1)
Trimix
Exposure to ambient pressure of maximum 11 ATA breathing Trimix. Exposure to oxygen partial pressure of 130 kPa breathing Trimix.
Interventions
Open sea diving to a maximum depth of 100 msw while breathing Trimix.
Open sea diving to a maximum depth of 100 msw while breathing Trimix.
Eligibility Criteria
Military divers and individuals approved by the Swedish navy to dive or perform work in hyperbaric environment.
You may qualify if:
- \- Military diver or individual approved by the Swedish navy to dive or perform work in hyperbaric environments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sahlgrenska University Hospitallead
- Göteborg Universitycollaborator
- Swedish Armed Forces Diving and Naval Medicine Centrecollaborator
- KTH Royal Institute of Technologycollaborator
Study Sites (1)
Gothenburg University
Gothenburg, S-405 30, Sweden
Biospecimen
Plasma, Serum.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Henrik Zetterberg, PhD
Göteborg University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD student
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 16, 2017
Study Start
June 12, 2017
Primary Completion
January 30, 2019
Study Completion
January 30, 2019
Last Updated
March 12, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share