- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02243345
Delayed Recompression for Decompression Sickness
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.
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Zerifin,, Israel, 70300
- Assaf-Harofeh Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Decompression sickness after diving
- Recompression Treatment between 2000-2014 in Assaf HaRofe medical center hyperbaric institute
Exclusion Criteria:
- Decompression sickness excluded
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
Delayed
Time from surfacing to recompression >=48 hours
|
Early
Time from surfacing to recompression <48 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcome evaluation
Time Frame: 14 days after treatment
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Shai Efrati, MD, Assaf Harofe Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 134/13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recompression Treatment After Decompression Sickness
-
University of PennsylvaniaUniversity of Maryland; Office of Naval Research (ONR)CompletedDecompression Sickness | DysbarismUnited States
-
University of PlymouthNot yet recruitingDecompression Sickness
-
University Hospital, BrestCompleted
-
BioAegis Therapeutics Inc.Not yet recruitingDecompression Sickness
-
Cancer Institute and Hospital, Chinese Academy...CompletedIntubation;DifficultChina
-
University Hospital of SplitUniversity of MarylandCompletedDecompression Sickness | SCUBA DivingUnited States, Croatia
-
Seoul National University HospitalSMG-SNU Boramae Medical CenterCompleted
-
Duke UniversityUnited States Department of DefenseCompletedAcute Mountain Sickness | Decompression SicknessUnited States
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedAnesthesia Intubation ComplicationsTaiwan
-
Centre Hospitalier Universitaire de Saint EtienneCompleted