<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/NCT03276494</url>
  </required_header>
  <id_info>
    <org_study_id>2017H0067</org_study_id>
    <nct_id>NCT03276494</nct_id>
  </id_info>
  <brief_title>Safety &amp; Tolerability of Hypertonic Saline Administration Via Intraosseous Access</brief_title>
  <official_title>Intraosseous Administration of Hypertonic Saline in Acute Brain-injured Patients: A Prospective Case Series and Literature Review</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertonic saline is used to treat elevated intracranial pressure. Intraosseous vascular&#xD;
      access has been used to administer fluids and medications. This study combines these to&#xD;
      administer 3% hypertonic saline via IO.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HTS is used to mitigate and temporize intracranial pressure (ICP) elevations and cerebral&#xD;
      edema by creating an osmotic gradient across the cell wall. HTS is part of the elevated ICP&#xD;
      algorithm in the emergency neurologic life support protocols HTS is superior to mannitol&#xD;
      which is the alternate osmotherapy agent . HTS is typically administered via central vascular&#xD;
      access due to the concern that if extravasation of the infusion occurs, tissue damage from&#xD;
      cell implosion can occur&#xD;
&#xD;
      The IO route is generally accepted in resuscitation environments including the emergency&#xD;
      department, EMS, and military settings with some authors recommending the IO as a primary&#xD;
      method of obtaining emergency vascular access The adult advanced cardiac life support (ACLS)&#xD;
      guidelines recommend either intravenous or IO access.&#xD;
&#xD;
      A number of studies have established the safety of IO administration of hypertonic solutions.&#xD;
      Randomized adult pigs to IO 7.5% HTS, IO 3% HTS, and 0.9% isotonic saline and found regular&#xD;
      tissue morphology, no necrosis or microscopic ischemic changes in the HTS groups. Several&#xD;
      studies conducted to evaluate the efficacy of hypertonic solutions on resuscitation for&#xD;
      hemorrhagic shock used the IO route and did not make note of problems arising from the&#xD;
      administration of IO HTS. Another study using a canine model of hemorrhagic shock briefly&#xD;
      mentioned transient lameness in the IO HTS group, but this resolved by 48 hours . While the&#xD;
      majority of studies using hypertonic saline solutions did not make note of complications, one&#xD;
      study induced hemorrhagic shock in dehydrated swine and resuscitated one group with 7.5% HTS&#xD;
      and noted a high rate of local complications from soft tissue and bone marrow necrosis .&#xD;
&#xD;
      One study noted a subgroup of patients in which IO access was obtained on conscious patients.&#xD;
      None of the patients received local anesthetic and none reported pain during insertion.&#xD;
      Eighteen of the 22 conscious patients reported pain during fluid administration. Central&#xD;
      venous catheter (CVC) placement is the current standard of care; even with local anesthesia&#xD;
      it can be painful. Most of the potential subjects, due to the nature of their severe&#xD;
      neurologic injury, may not be affected by the pain associated with IO fluid administration.&#xD;
      Manufacturer literature suggests the use of lidocaine to anesthetize the bone before infusing&#xD;
      if possible (Teleflex).&#xD;
&#xD;
      It is expected that utilizing IO for vascular access in the ICU will be safe and tolerable.&#xD;
      If this study confirms the anticipated results, there are numerous implications. First,&#xD;
      neurologically injured patients requiring emergent HTS may have faster access to this&#xD;
      therapy. A study comparing IO to CVC access undergoing resuscitation in the emergency&#xD;
      department found IO to be faster to insert (2.3 vs. 9.9 minutes) and had fewer failures to&#xD;
      access on the first attempt. Second, serious complications from IO were absent compared with&#xD;
      severe to life-threatening mechanical complications from CVC including pneumothorax, damage&#xD;
      to the carotid artery, and bleeding which were cited at 0.7%-2.1% depending on site. And&#xD;
      thirdly, central line associated blood stream infections (CLABSI) are a leading cause of&#xD;
      hospital acquired infections in the ICU and are associated with higher mortality. CLABSI&#xD;
      rates are measured by number of infections per 1,000 catheter days and shorter CVC dwell time&#xD;
      is prudent. If a reliable and rapid source of vascular access could postpone or eliminate CVC&#xD;
      insertion, risk of CLABSI may be reduced. These potential benefits outweigh the minimal&#xD;
      expected risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 21, 2017</start_date>
  <completion_date type="Actual">April 21, 2018</completion_date>
  <primary_completion_date type="Actual">April 21, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>prospective case series</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects With Tissue Damage</measure>
    <time_frame>24 hours</time_frame>
    <description>Number of subjects with tissue damage (e.g. Myonecrosis, Skin necrosis, Extravasation, Compartment syndrome, Osteomyelitis). These data points will be determined by clinician assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Scale</measure>
    <time_frame>24 hours</time_frame>
    <description>Pain (CPOT-critical care pain observation tool). All non-verbal subjects have pain assessed with a CPOT score, as observed by clinicians. The CPOT is a validated pain score for nonverbal patients. This tool assesses pain with nonverbal indicators, adding 1-2 points for several nonverbal indicators of pain, 0 if the nonverbal indicator is absent, and is reported as a total summed score. It ranges from 0-8, with 0 indicating no pain and 8 indicating high pain.&#xD;
No patients were verbal, so the numeric pain rating scale was not used for any patients.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Stroke</condition>
  <condition>Intracranial Hypotension</condition>
  <condition>Cerebral Edema</condition>
  <arm_group>
    <arm_group_label>Intraosseous</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Administration of intraosseous hypertonic saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intraosseous</intervention_name>
    <description>Intraosseous administration of hypertonic saline</description>
    <arm_group_label>Intraosseous</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hypertonic saline</intervention_name>
    <description>Intraosseous administration of hypertonic saline</description>
    <arm_group_label>Intraosseous</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NCCU patients in which osmotherapy with HTS is planned (standard of care&#xD;
&#xD;
          -  Does not already have a CVC or PICC.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years old&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Long bone fracture in the targeted site&#xD;
&#xD;
          -  Proximity to prosthetic joint&#xD;
&#xD;
          -  Excessive tissue/absence of anatomical landmarks&#xD;
&#xD;
          -  History of osteopetrosis&#xD;
&#xD;
          -  Previous significant orthopedic procedure at site&#xD;
&#xD;
          -  Prosthetic limb or joint&#xD;
&#xD;
          -  IO catheter use in the past 48 hours of the target bone&#xD;
&#xD;
          -  Infection at the area of insertion&#xD;
&#xD;
          -  Hypersensitivity to lidocaine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>June 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <results_first_submitted>May 10, 2019</results_first_submitted>
  <results_first_submitted_qc>June 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 9, 2019</results_first_posted>
  <last_update_submitted>June 18, 2019</last_update_submitted>
  <last_update_submitted_qc>June 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Archana Hinduja</investigator_full_name>
    <investigator_title>Assistant Professor Division of Cerebrovascular Disease and Neurocritical Care</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Edema</mesh_term>
    <mesh_term>Intracranial Hypotension</mesh_term>
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>manuscript on the case series has been submitted</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03276494/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intraosseous</title>
          <description>Administration of intraosseous hypertonic saline&#xD;
Intraosseous: Intraosseous administration of hypertonic saline&#xD;
Hypertonic saline: Intraosseous administration of hypertonic saline</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intraosseous</title>
          <description>Administration of intraosseous hypertonic saline&#xD;
Intraosseous: Intraosseous administration of hypertonic saline&#xD;
Hypertonic saline: Intraosseous administration of hypertonic saline</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Tissue Damage</title>
        <description>Number of subjects with tissue damage (e.g. Myonecrosis, Skin necrosis, Extravasation, Compartment syndrome, Osteomyelitis). These data points will be determined by clinician assessment.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intraosseous</title>
            <description>Administration of intraosseous hypertonic saline&#xD;
Intraosseous: Intraosseous administration of hypertonic saline&#xD;
Hypertonic saline: Intraosseous administration of hypertonic saline</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Tissue Damage</title>
          <description>Number of subjects with tissue damage (e.g. Myonecrosis, Skin necrosis, Extravasation, Compartment syndrome, Osteomyelitis). These data points will be determined by clinician assessment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Scale</title>
        <description>Pain (CPOT-critical care pain observation tool). All non-verbal subjects have pain assessed with a CPOT score, as observed by clinicians. The CPOT is a validated pain score for nonverbal patients. This tool assesses pain with nonverbal indicators, adding 1-2 points for several nonverbal indicators of pain, 0 if the nonverbal indicator is absent, and is reported as a total summed score. It ranges from 0-8, with 0 indicating no pain and 8 indicating high pain.&#xD;
No patients were verbal, so the numeric pain rating scale was not used for any patients.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intraosseous</title>
            <description>Administration of intraosseous hypertonic saline&#xD;
Intraosseous: Intraosseous administration of hypertonic saline&#xD;
Hypertonic saline: Intraosseous administration of hypertonic saline</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scale</title>
          <description>Pain (CPOT-critical care pain observation tool). All non-verbal subjects have pain assessed with a CPOT score, as observed by clinicians. The CPOT is a validated pain score for nonverbal patients. This tool assesses pain with nonverbal indicators, adding 1-2 points for several nonverbal indicators of pain, 0 if the nonverbal indicator is absent, and is reported as a total summed score. It ranges from 0-8, with 0 indicating no pain and 8 indicating high pain.&#xD;
No patients were verbal, so the numeric pain rating scale was not used for any patients.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intraosseous</title>
          <description>Administration of intraosseous hypertonic saline&#xD;
Intraosseous: Intraosseous administration of hypertonic saline&#xD;
Hypertonic saline: Intraosseous administration of hypertonic saline</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Thomas Lawson</name_or_title>
      <organization>Ohio State University</organization>
      <phone>614-366-7312</phone>
      <email>thomas.lawson@osumc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03276494
org study id: 2017H0067
nct id: NCT03276494
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: Yes
Hypertonic saline is used to treat elevated intracranial pressure. Intraosseous vascular
      access has been used to administer fluids and medications. This study combines these to
      administer 3% hypertonic saline via IO.
HTS is used to mitigate and temporize intracranial pressure (ICP) elevations and cerebral
      edema by creating an osmotic gradient across the cell wall. HTS is part of the elevated ICP
      algorithm in the emergency neurologic life support protocols HTS is superior to mannitol
      which is the alternate osmotherapy agent . HTS is typically administered via central vascular
      access due to the concern that if extravasation of the infusion occurs, tissue damage from
      cell implosion can occur

      The IO route is generally accepted in resuscitation environments including the emergency
      department, EMS, and military settings with some authors recommending the IO as a primary
      method of obtaining emergency vascular access The adult advanced cardiac life support (ACLS)
      guidelines recommend either intravenous or IO access.

      A number of studies have established the safety of IO administration of hypertonic solutions.
      Randomized adult pigs to IO 7.5% HTS, IO 3% HTS, and 0.9% isotonic saline and found regular
      tissue morphology, no necrosis or microscopic ischemic changes in the HTS groups. Several
      studies conducted to evaluate the efficacy of hypertonic solutions on resuscitation for
      hemorrhagic shock used the IO route and did not make note of problems arising from the
      administration of IO HTS. Another study using a canine model of hemorrhagic shock briefly
      mentioned transient lameness in the IO HTS group, but this resolved by 48 hours . While the
      majority of studies using hypertonic saline solutions did not make note of complications, one
      study induced hemorrhagic shock in dehydrated swine and resuscitated one group with 7.5% HTS
      and noted a high rate of local complications from soft tissue and bone marrow necrosis .

      One study noted a subgroup of patients in which IO access was obtained on conscious patients.
      None of the patients received local anesthetic and none reported pain during insertion.
      Eighteen of the 22 conscious patients reported pain during fluid administration. Central
      venous catheter (CVC) placement is the current standard of care; even with local anesthesia
      it can be painful. Most of the potential subjects, due to the nature of their severe
      neurologic injury, may not be affected by the pain associated with IO fluid administration.
      Manufacturer literature suggests the use of lidocaine to anesthetize the bone before infusing
      if possible (Teleflex).

      It is expected that utilizing IO for vascular access in the ICU will be safe and tolerable.
      If this study confirms the anticipated results, there are numerous implications. First,
      neurologically injured patients requiring emergent HTS may have faster access to this
      therapy. A study comparing IO to CVC access undergoing resuscitation in the emergency
      department found IO to be faster to insert (2.3 vs. 9.9 minutes) and had fewer failures to
      access on the first attempt. Second, serious complications from IO were absent compared with
      severe to life-threatening mechanical complications from CVC including pneumothorax, damage
      to the carotid artery, and bleeding which were cited at 0.7%-2.1% depending on site. And
      thirdly, central line associated blood stream infections (CLABSI) are a leading cause of
      hospital acquired infections in the ICU and are associated with higher mortality. CLABSI
      rates are measured by number of infections per 1,000 catheter days and shorter CVC dwell time
      is prudent. If a reliable and rapid source of vascular access could postpone or eliminate CVC
      insertion, risk of CLABSI may be reduced. These potential benefits outweigh the minimal
      expected risk.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: prospective case series
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Subjects With Tissue Damage
time frame: 24 hours
description: Number of subjects with tissue damage (e.g. Myonecrosis, Skin necrosis, Extravasation, Compartment syndrome, Osteomyelitis). These data points will be determined by clinician assessment.
measure: Pain Scale
time frame: 24 hours
description: Pain (CPOT-critical care pain observation tool). All non-verbal subjects have pain assessed with a CPOT score, as observed by clinicians. The CPOT is a validated pain score for nonverbal patients. This tool assesses pain with nonverbal indicators, adding 1-2 points for several nonverbal indicators of pain, 0 if the nonverbal indicator is absent, and is reported as a total summed score. It ranges from 0-8, with 0 indicating no pain and 8 indicating high pain.
No patients were verbal, so the numeric pain rating scale was not used for any patients.
arm group label: Intraosseous
arm group type: Other
description: Administration of intraosseous hypertonic saline
intervention type: Device
intervention name: Intraosseous
description: Intraosseous administration of hypertonic saline
arm group label: Intraosseous
intervention type: Drug
intervention name: Hypertonic saline
description: Intraosseous administration of hypertonic saline
arm group label: Intraosseous
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Archana Hinduja
investigator title: Assistant Professor Division of Cerebrovascular Disease and Neurocritical Care
mesh term: Brain Edema
mesh term: Intracranial Hypotension
mesh term: Hypotension
sharing ipd: Yes
ipd description: manuscript on the case series has been submitted
ipd info type: Clinical Study Report (CSR)
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 