<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02243345</url>
  </required_header>
  <id_info>
    <org_study_id>134/13</org_study_id>
    <nct_id>NCT02243345</nct_id>
  </id_info>
  <brief_title>Delayed Recompression for Decompression Sickness</brief_title>
  <official_title>Delayed Recompression for Decompression Sickness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assaf-Harofeh Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assaf-Harofeh Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Decompression sickness syndrome (DCS) is caused by microbubbles forming in blood vessels or&#xD;
      tissues during a reduction in environmental pressure (decompression). Bubbles have&#xD;
      mechanical, embolic and biochemical effects with manifestations ranging from none to fatal.&#xD;
      By reducing bubble volume and hastening inert gas elimination, recompression therapy with&#xD;
      hyperbaric treatment remains the main therapy for DCS. The most common hyperbaric protocol&#xD;
      used, is based on US Navy Treatment table 6, started as early as possible after surfacing.&#xD;
      The outcome of hyperbaric therapy varies with reported complete resolution in 13%-63% of the&#xD;
      patients suffering from severe DCS, and in 73%-100% of the patients with mild-moderate DCS.&#xD;
&#xD;
      The significance of time to recompression is controversial. It has been suggested that early&#xD;
      hyperbaric treatment improves the outcome by decreasing bubble size and avoiding further&#xD;
      tissue injury. However, in recent studies time to recompression had very little effect on&#xD;
      clinical recovery. Moreover, the time beyond which hyperbaric treatment isn't effective has&#xD;
      not been determined yet.&#xD;
&#xD;
      The aim of this study was to evaluate the clinical outcome of delayed hyperbaric treatment to&#xD;
      divers who referred to tertiary care hospital hyperbaric unit, more than 48 hours after&#xD;
      surfacing. The clinical outcome of the delayed hyperbaric treatments was compared to early&#xD;
      treatments given at the same hyperbaric unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From January 2000 to February 2014, 204 divers were treated for DCS in the institute of&#xD;
      Hyperbaric Medicine, Assaf Harofeh Medical Center, Israel.&#xD;
&#xD;
      The data will be collected retrospectively from medical records and include age, sex, diving&#xD;
      experience, maximal depth, DCS possible cause, DCS type, symptoms, time from surfacing to&#xD;
      symptoms onset, time from surfacing to recompression, recompression table, additional&#xD;
      treatment after the first recompression and treatment outcome.&#xD;
&#xD;
      Statistical analysis will be done using univariant analysis was performed using Spearman's&#xD;
      correlation and Chi-Square in categoric variabales, independent t-test in numeric variables.&#xD;
      This will be performed in SPSS v.21 software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical outcome evaluation</measure>
    <time_frame>14 days after treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">204</enrollment>
  <condition>Recompression Treatment After Decompression Sickness</condition>
  <arm_group>
    <arm_group_label>Delayed</arm_group_label>
    <description>Time from surfacing to recompression &gt;=48 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early</arm_group_label>
    <description>Time from surfacing to recompression &lt;48 hours</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Decompression sickness patients treated with hyperbaric recompression&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Decompression sickness after diving&#xD;
&#xD;
          -  Recompression Treatment between 2000-2014 in Assaf HaRofe medical center hyperbaric&#xD;
             institute&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Decompression sickness excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shai Efrati, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Assaf Harofe Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assaf-Harofeh Medical Center</name>
      <address>
        <city>Zerifin,</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>decompression</keyword>
  <keyword>recompression</keyword>
  <keyword>delayed</keyword>
  <keyword>late</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Decompression Sickness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02243345
org study id: 134/13
nct id: NCT02243345
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Retrospective
measure: Clinical outcome evaluation
time frame: 14 days after treatment
description: 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.
arm group label: Delayed
description: Time from surfacing to recompression >=48 hours
arm group label: Early
description: Time from surfacing to recompression <48 hours
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Shai Efrati, MD
role: Study Chair
affiliation: Assaf Harofe Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Decompression Sickness