This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Anders Rosén, Sahlgrenska University Hospital, Sweden
Sponsor:
Collaborators:
Göteborg University
Swedish Armed Forces Diving and Naval Medicine Centre
Kungliga Tekniska Högskolan
Information provided by (Responsible Party):
Anders Rosén, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT03190252
First received: June 14, 2017
Last updated: June 16, 2017
Last verified: June 2017
  Purpose

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 Intervention
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 Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biokemiska förändringar Vid förhöjt Partialtryck för Syrgas

Further study details as provided by Anders Rosén, Sahlgrenska University Hospital, Sweden:

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

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

Biospecimen Retention:   Samples Without DNA
Plasma, Serum.

Estimated Enrollment: 32
Actual Study Start Date: June 12, 2017
Estimated Study Completion Date: September 30, 2018
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 14, 2017
Last Updated: June 16, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 28, 2017