An observational study in Recompression Treatment After Decompression Sickness, sponsored by Assaf-Harofeh Medical Center. Completed at 1 site in Israel. Per ClinicalTrials.gov, last updated 2014-09-17.
Sponsored by Assaf-Harofeh Medical Center · 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.
From January 2000 to February 2014, 204 divers were treated for DCS in the institute of Hyperbaric Medicine, Assaf Harofeh Medical Center, Israel.
The data will be collected retrospectively from medical records and include age, sex, diving experience, maximal depth, DCS possible cause, DCS type, symptoms, time from surfacing to symptoms onset, time from surfacing to recompression, recompression table, additional treatment after the first recompression and treatment outcome.
Statistical analysis will be done using univariant analysis was performed using Spearman's correlation and Chi-Square in categoric variabales, independent t-test in numeric variables. This will be performed in SPSS v.21 software.
21 studies on the registry are indexed under Decompression Sickness; 6 are open to participants now.
This study's enrollment of 204 is above the median of 74 across 12 observational studies indexed under Decompression Sickness.
Browse Decompression Sickness studies →Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.
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Decompression sickness patients treated with hyperbaric recompression
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Exclusion Criteria:
Time from surfacing to recompression \>=48 hours
Time from surfacing to recompression \<48 hours
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.
Time frame: 14 days after treatment
The record gives a start of Sep 2013, a primary completion of Jun 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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