Recompression Treatment After Decompression Sickness Clinical Trial
Official title:
Delayed Recompression for Decompression Sickness
| Verified date | September 2014 |
| Source | Assaf-Harofeh Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Observational |
Decompression sickness syndrome (DCS) is caused by microbubbles forming in blood vessels or
tissues during a reduction in environmental pressure (decompression). Bubbles have
mechanical, embolic and biochemical effects with manifestations ranging from none to fatal.
By reducing bubble volume and hastening inert gas elimination, recompression therapy with
hyperbaric treatment remains the main therapy for DCS. The most common hyperbaric protocol
used, is based on US Navy Treatment table 6, started as early as possible after surfacing.
The outcome of hyperbaric therapy varies with reported complete resolution in 13%-63% of the
patients suffering from severe DCS, and in 73%-100% of the patients with mild-moderate DCS.
The significance of time to recompression is controversial. It has been suggested that early
hyperbaric treatment improves the outcome by decreasing bubble size and avoiding further
tissue injury. However, in recent studies time to recompression had very little effect on
clinical recovery. Moreover, the time beyond which hyperbaric treatment isn't effective has
not been determined yet.
The aim of this study was to evaluate the clinical outcome of delayed hyperbaric treatment
to divers who referred to tertiary care hospital hyperbaric unit, more than 48 hours after
surfacing. The clinical outcome of the delayed hyperbaric treatments was compared to early
treatments given at the same hyperbaric unit.
| Status | Completed |
| Enrollment | 204 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Decompression sickness after diving - Recompression Treatment between 2000-2014 in Assaf HaRofe medical center hyperbaric institute Exclusion Criteria: - Decompression sickness excluded |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Assaf-Harofeh Medical Center | Zerifin, |
| Lead Sponsor | Collaborator |
|---|---|
| Assaf-Harofeh Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical outcome evaluation | Clinical outcome will be reviewed from the medical records. The outcome was evaluated by a hyperbaric physician within 14 days from recompression. The outcome will be scored as complete, partial or no recovery. | 14 days after treatment | No |