Recompression Treatment After Decompression SicknessNCT02243345
Delayed Recompression for Decompression Sickness
An observational study of Recompression Treatment After Decompression Sickness, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recompression Treatment After Decompression Sickness
- How many people
- 204 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Jun 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Decompression sickness patients treated with hyperbaric recompression
Who may be able to join
- Decompression sickness after diving
- Recompression Treatment between 2000-2014 in Assaf HaRofe medical center hyperbaric institute
Who cannot join
- Decompression sickness excluded
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- decompression, recompression, delayed, late
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Delayed | Time from surfacing to recompression >=48 hours | |
| Early | Time from surfacing to recompression <48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recompression Treatment After Decompression SicknessStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shai Efrati, MD, Study chair, Assaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243345
- Sponsor's protocol ID
- 134/13
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Recompression for Decompression Sickness
- ClinicalTrials.gov ID
- NCT02243345
- Acronym / sponsor ID
- 134/13
- Keywords
- decompression, recompression, delayed, late
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Sep 2014 (estimated)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed | – | –Time from surfacing to recompression >=48 hours |
| Early | – | –Time from surfacing to recompression <48 hours |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Decompression sickness patients treated with hyperbaric recompression
Key inclusion criteria (2 listed)
- Decompression sickness after diving
- Recompression Treatment between 2000-2014 in Assaf HaRofe medical center hyperbaric institute
Key exclusion criteria (1 listed)
- Decompression sickness excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
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.
Shai Efrati, MD study chair
Assaf Harofe Medical Center
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 Recompression Treatment After Decompression Sickness, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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: finished, as of the sponsor's last update on 17 Sep 2014. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome evaluation (time frame: 14 days after treatment). 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 17 Sep 2014.