Markers of Central Nervous System Injury in Decompression Sickness (DCS NEURO)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    40
  • sponsor
    Sahlgrenska University Hospital, Sweden
Updated on 25 February 2022

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.

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.

Details
Condition Decompression Sickness
Treatment No active intervention
Clinical Study IdentifierNCT03192956
SponsorSahlgrenska University Hospital, Sweden
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Presence of decompression sickness
Signed informed consent

Exclusion Criteria

As this is a highly selected population there is no exclusion criteria
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note