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Inflammatory and Cerebrospinal Biochemical Markers in Blood During Prolonged Hyperbaric Exposure (Mättnad2017)

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ClinicalTrials.gov Identifier: NCT03192930
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
Swedish Armed Forces Diving and Naval Medicine Centre
KTH Royal Institute of Technology
Information provided by (Responsible Party):
Anders Rosén, Sahlgrenska University Hospital, Sweden

Brief Summary:

Research hypothesis

  • Prolonged hyperbaric exposure will affect the central nervous system
  • Prolonged hyperbaric exposure will induce inflammatory changes
  • Prolonged hyperbaric exposure will affect fluid regulation in the body

Objectives:

  • To investigate the presence of cerebrospinal biochemical markers in blood during prolonged hyperbaric exposure
  • To investigate changes in the quantity of cerebrospinal biochemical markers in blood during decompression after prolonged hyperbaric exposure
  • To investigate the presence of inflammatory markers in blood during prolonged hyperbaric exposure
  • To investigate changes in the quantity of inflammatory markers in blood during decompression after prolonged hyperbaric exposure
  • To investigate if prolonged hyperbaric exposure alters fluid balance in the body

Condition or disease Intervention/treatment
Saturation Exposure Decompression Injury Other: Hyperbaric exposure

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatoriska Och Neurokemiska förändringar Vid ökat Omgivningstryck
Actual Study Start Date : March 17, 2017
Actual Primary Completion Date : January 17, 2018
Actual Study Completion Date : January 17, 2018

Group/Cohort Intervention/treatment
Saturation
Individuals exposed to prolonged hyperbaric exposure
Other: Hyperbaric exposure
Hyperbaric exposure 4 ATA for 36 hours followed by 70 hours decompression

Control
Individuals not exposed to prolonged hyperbaric exposure



Primary Outcome Measures :
  1. Concentration of inflammatory and cerebrospinal biochemical markers in blood [ Time Frame: 14 days ]
    E. g: tau, NfL, GFAP, UCHL-1, VCAM-1, ICAM-1, Endothemin-1 and others


Secondary Outcome Measures :
  1. Biochemical signs of altered fluid balance in the body [ Time Frame: 7 days ]
    Hematocrit

  2. Changes in lung function [ Time Frame: 7 days ]
    Spirometry (FVC, FEV, diffusing capacity)

  3. Presence of Venous gas Emboli (VGE) [ Time Frame: 7 days ]
    Doppler and 2-D echocardiography

  4. Decompression sickness (DCS) [ Time Frame: 7 days ]
    Clinical diagnosis


Biospecimen Retention:   Samples Without DNA
Serum. Plasma.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

Submariners and divers employed by the Swedish navy and individuals approved by the Swedish navy for work in a hyperbaric environment participating in the Swedish navy saturation diving tests.

Submariners and divers employed by the Swedish navy and individuals approved by the Swedish navy for work in a hyperbaric environment not participating in the Swedish navy saturation diving tests.

Criteria

Inclusion Criteria:

  • Submariners and divers employed by the Swedish navy or individuals approved by the Swedish navy for work in a hyperbaric Environment.
  • Subjects in the intervention group must be participating in the Swedish navy saturation diving tests.

Exclusion Criteria:

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


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): NCT03192930


Locations
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Sweden
Gothenburg University
Gothenburg, Sweden, S-405 30
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Swedish Armed Forces Diving and Naval Medicine Centre
KTH Royal Institute of Technology
Investigators
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Study Director: Henrik Zetterberg, PhD Göteborg University

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Responsible Party: Anders Rosén, MD PhD student, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03192930     History of Changes
Other Study ID Numbers: EPN 022-17
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Hyperbaric
Saturation
Decompression injury
Decompression sickness
Inflammation
Central nervous system injury
Diving medicine