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
Research hypothesis
Objectives:
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.
21 studies on the registry are indexed under Decompression Sickness; 6 are open to participants now.
This study's planned enrollment of 40 is below the median of 74 across 12 observational studies indexed under Decompression Sickness.
Browse Decompression Sickness studies →Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The research subjects are recruited, on voluntary basis, among divers with decompression sickness treated at the hyperbaric facility at Sahlgrenska Universuty Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No active intervention is performed
Biochemical signs of central nervous system injury
E. g: Tau, NfL, GFAP, UCHL-1
Time frame: 6 months
Inflammatory activity
E. g: VCAM-1, ICAM-1, Endothelin-1
Time frame: 6 months
Symptoms of decompression sickness
Clinical diagnosis
Time frame: 24 hours
Dive time
Minutes
Time frame: 1 hour
Dive depth
Meters of seawater
Time frame: 1 hour
Remaining symptoms of decompression sickness after 3-6 months
Clinical diagnosis
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
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