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Decompression SicknessDCS NEURONCT03192956

Markers of Central Nervous System Injury in Decompression Sickness

An observational study of Decompression Sickness, run by Sahlgrenska University Hospital at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Decompression Sickness
What is being tested?
No active intervention
How many people
40 participants
Where
1 siteSweden
Study dates
1 May 2017to 30 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Presence of decompression sickness
  • Signed informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Anders Rosén, PhD contact

+46725088800

bandersrosen@gmail.com

Sweden1 site, 1 recruiting
  • Gothenburg University

    Gothenburg, S-405 30

    Henrik Zetterberg, PhD, +46313421000, henrik.zetterberg@gu.se

    Recruiting

Other trials in Sweden

About this study

Official title: Neuroskademarkörer Vid Dykarsjuka

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.
Read more

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.

Being tested
No active intervention
Keywords
Hyperbaric, Decompression sickness, Decompression injury, Inflammation, Central nervous injury, Hybervaric oxygen therapy
Medical subject headings
Decompression Sickness, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No active interventionOther

    No active intervention is performed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical signs of central nervous system injury

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

    Measured: 6 months

Secondary outcomes (5)
  1. Inflammatory activity

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

    Measured: 6 months

  2. Symptoms of decompression sickness

    Clinical diagnosis

    Measured: 24 hours

  3. Dive time

    Minutes

    Measured: 1 hour

  4. Dive depth

    Meters of seawater

    Measured: 1 hour

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

    Clinical diagnosis

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2017
  2. Study start1 May 2017
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03192956
Sponsor's protocol ID
EPN 552-16
Acronym
DCS NEURO
Status last verified
Dec 2023
First submitted
14 Jun 2017
Last updated
14 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Decompression Sickness, run by Sahlgrenska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anders Rosén, PhD (+46725088800, bandersrosen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical signs of central nervous system injury (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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