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Inflammatory and Cerebrospinal Biochemical Markers in Blood After Trimix Diving (TriMix17-18)

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ClinicalTrials.gov Identifier: NCT03190252
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : June 19, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diving Medicine Inflammation Central Nervous System Injury Other: Exposure to oxygen partial pressure of 130 kPa Other: Exposure to ambient pressure of maximum 11 ATA

Study Design

Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biokemiska förändringar Vid förhöjt Partialtryck för Syrgas
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 30, 2018
Groups and Cohorts

Group/Cohort Intervention/treatment
Trimix
Exposure to ambient pressure of maximum 11 ATA breathing Trimix. Exposure to oxygen partial pressure of 130 kPa breathing Trimix.
Other: Exposure to oxygen partial pressure of 130 kPa
Open sea diving to a maximum depth of 100 msw while breathing Trimix.
Other: Exposure to ambient pressure of maximum 11 ATA
Open sea diving to a maximum depth of 100 msw while breathing Trimix.
Control
Not diving


Outcome Measures

Primary Outcome Measures :
  1. Concentration of cerebrospinal and inflammatory biochemical markers in blood [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. Presence of Venous Gas Emboli (VGE) [ Time Frame: Five days ]
  2. Decompression Sickness (DCS) [ Time Frame: Five days ]

Biospecimen Retention:   Samples Without DNA
Plasma, Serum.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Military divers and individuals approved by the Swedish navy to dive or perform work in hyperbaric environment.
Criteria

Inclusion Criteria:

- Military diver or individual approved by the Swedish navy to dive or perform work in hyperbaric environments

Exclusion Criteria:

- As this is a highly selected population there is no exclusion criteria

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190252


Contacts
Contact: Anders Rosén, MD +46725088800 anders.rosen@vgregion.se

Locations
Sweden
Gothenburg University Recruiting
Gothenburg, Sweden, S-405 30
Contact: Henrik Zetterberg, PhD    +46313421000    henrik.zetterberg@gu.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Göteborg University
Swedish Armed Forces Diving and Naval Medicine Centre
Kungliga Tekniska Högskolan
Investigators
Study Director: Henrik Zetterberg, PhD Göteborg University
More Information

Responsible Party: Anders Rosén, MD PhD student, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03190252     History of Changes
Other Study ID Numbers: EPN 292-17
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anders Rosén, Sahlgrenska University Hospital, Sweden:
Diving medicine
Inflammation
Central nervous system injury
Trimix
Decompression sickness
Venous gas emboli

Additional relevant MeSH terms:
Inflammation
Trauma, Nervous System
Pathologic Processes
Nervous System Diseases
Wounds and Injuries