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RecruitingNCT03192956DCS NEUROUpdated Dec 14, 2023

Markers of Central Nervous System Injury in Decompression Sickness

An observational study in Decompression Sickness, sponsored by Sahlgrenska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by Sahlgrenska University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

Research hypothesis

  • There is a correlation between the quantity of fluid markers of CNS injury in blood and DCS.
  • There is a correlation between quantity and kind of fluid markers of CNS injury in blood and both diving profile and severity of DCS.
  • There is a correlation between the quantity of inflammatory markers in blood an DCS.

Objectives:

  • Assess whether individuals suffering decompression sickness exhibit fluid markers of central nervous system injury.
  • Evaluate the correlation between quantity and kind of fluid marker of CNS injury and clinical signs of neurological impairment.
  • Evaluate the correlation between quantity and kind of fluid marker of CNS injury and clinical outcome after 3-6 months.
  • Assess whether individuals suffering decompression sickness exhibit inflammatory markers in blood.
Read the detailed description

Decompression sickness (DCS) is a risk associated with diving. Common symptoms are joint and limb pain, skin rash, ataxia, hemiplegia, visual disturbances, paresthesias, limb numbness, nystagmus and vertigo. Treatment consists of recompression in a hyperbaric chamber, commonly referred to as hyperbaric oxygen treatment (HBOT).

It has been thought since the last quarter of the 19th century that DCS is caused by bubble formation in the tissues when dissolved inert gas comes out of solution. It was long thought that decompression schedules that did not give rise to any gas bubbles in the body also averted DCS. However, with the advent of ultrasound Doppler technology in the 1970s it was found that intravascular gas bubbles could exist even after uneventful dives. Dives well within limits established by military and sports authorities have been shown to generate intravascular bubbles. Hence, additional pathophysiological factors have been sought.

There is evidence of endothelial dysfunction, coagulopathy and inflammatory activation after diving. Though, their role in the pathophysiology of DCS remains to be determined.

Studies have shown that fluid markers of CNS injury can be found in blood samples obtained from athletes practising ice-hockey, boxing and american football. There is reason to believe that fluid markers of CNS injury will be present in blood samples obtained from divers with DCS as well.

Study subjects will be recruited by the attending physician at the Hyperbaric chamber at SU/Omrade 2 after the patient has been given a diagnosis of decompression sickness. Prior to treatment in the hyperbaric chamber, 4 ml of blood will be drawn via a plastic intravenous catheter that is placed in an arm vein as part of normal, established care of injured divers in the Emergency Department (to provide intravenous fluid and medications). A second 4 ml sample will be obtained from the same catheter after the patient has completed treatment (the typical hyperbaric treatment for decompression sickness lasts \~5.5 hours). The study object will also provide information regarding his/her general health and the completed dive. All study data, including blood samples, will anonymized and provided with a study code.

When feasible, blood samples will be obtained 1 week and 3-6 months after HBOT. These samples will be handled the same as the two obtained on the day of injury.

02

Conditions studied

  • Decompression Sickness

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Keywords

  • Hyperbaric
  • Decompression sickness
  • Decompression injury
  • Inflammation
  • Central nervous injury
  • Hybervaric oxygen therapy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The research subjects are recruited, on voluntary basis, among divers with decompression sickness treated at the hyperbaric facility at Sahlgrenska Universuty Hospital.

Inclusion criteria

  • Presence of decompression sickness
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • As this is a highly selected population there is no exclusion criteria
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherNo active intervention

    No active intervention is performed

05

What researchers measure

Primary outcomes

  1. Biochemical signs of central nervous system injury

    E. g: Tau, NfL, GFAP, UCHL-1

    Time frame: 6 months

Secondary outcomes

  1. Inflammatory activity

    E. g: VCAM-1, ICAM-1, Endothelin-1

    Time frame: 6 months

  2. Symptoms of decompression sickness

    Clinical diagnosis

    Time frame: 24 hours

  3. Dive time

    Minutes

    Time frame: 1 hour

  4. Dive depth

    Meters of seawater

    Time frame: 1 hour

  5. Remaining symptoms of decompression sickness after 3-6 months

    Clinical diagnosis

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Gothenburg University
    Gothenburg, S-405 30, Sweden
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03192956
Lead sponsor
Sahlgrenska University Hospital
Collaborators
Göteborg University
Responsible party
Anders Rosén (MD PhD, Sahlgrenska University Hospital) — Principal investigator
First posted
Jun 20, 2017
Start date
May 1, 2017
Primary completion
Jun 1, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Dec 14, 2023

Study contacts

Anders Rosén, PhD
Contact
bandersrosen@gmail.com
+46725088800
Henrik Zetterberg, PhD
study director · Göteborg University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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