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.
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.
Sweden1 site, 1 recruiting
- Recruiting
Gothenburg University
Gothenburg, S-405 30
Henrik Zetterberg, PhD, +46313421000, henrik.zetterberg@gu.se
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.
- Conditions
- Decompression Sickness
- 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.
Biochemical signs of central nervous system injury
- g: Tau, NfL, GFAP, UCHL-1
Measured: 6 months
Secondary outcomes (5)
Inflammatory activity
- g: VCAM-1, ICAM-1, Endothelin-1
Measured: 6 months
Symptoms of decompression sickness
Clinical diagnosis
Measured: 24 hours
Dive time
Minutes
Measured: 1 hour
Dive depth
Meters of seawater
Measured: 1 hour
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.
- First posted20 Jun 2017
- Study start1 May 2017
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompression SicknessStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Anders Rosén, Sahlgrenska University Hospital
- Investigators
- Henrik Zetterberg, PhD, Study director, Göteborg University
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroskademarkörer Vid Dykarsjuka
- ClinicalTrials.gov ID
- NCT03192956
- Acronym / sponsor ID
- DCS NEURO / EPN 552-16
- Conditions
- Decompression Sickness
- Keywords
- Hyperbaric, Decompression sickness, Decompression injury, Inflammation, Central nervous injury, Hybervaric oxygen therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Presence of decompression sickness
- Signed informed consent
Key exclusion criteria (1 listed)
- As this is a highly selected population there is no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No active interventionNo active intervention is performed | Other | – |
Primary outcome
Biochemical signs of central nervous system injury
Time frame: 6 months
E. g: Tau, NfL, GFAP, UCHL-1
5 secondary outcomes
Inflammatory activity
Time frame: 6 months
Symptoms of decompression sickness
Time frame: 24 hours
Dive time
Time frame: 1 hour
Dive depth
Time frame: 1 hour
Remaining symptoms of decompression sickness after 3-6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Zetterberg, PhD study director
Göteborg University
1 site in 1 country: see every site and its status.
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.