<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/NCT01699373</url>
  </required_header>
  <id_info>
    <org_study_id>UGSA/2010</org_study_id>
    <nct_id>NCT01699373</nct_id>
  </id_info>
  <brief_title>A Trial on Ultrasound-assisted Spinal Anaesthesia</brief_title>
  <official_title>A Randomised Controlled Trial on Ultrasound-assisted Spinal Anaesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changi General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changi General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with&#xD;
      manual palpation to identify landmarks for performance of spinal anaesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success Rate of First-attempt of Spinal Anaesthesia</measure>
    <time_frame>During procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time Taken to Perform Spinal Anaesthesia</measure>
    <time_frame>During procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Spinal Anaesthesia</condition>
  <condition>Ultrasound</condition>
  <arm_group>
    <arm_group_label>Ultrasound-assisted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-procedural ultrasound scan performed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual Palpation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound scan</intervention_name>
    <description>Pre-procedural ultrasound scan was performed</description>
    <arm_group_label>Ultrasound-assisted</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I to III&#xD;
&#xD;
          -  undergoing surgery amenable to spinal anaesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  contraindications to regional anaesthesia&#xD;
&#xD;
          -  known allergy to local anaesthetics&#xD;
&#xD;
          -  bleeding diathesis&#xD;
&#xD;
          -  inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>September 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>February 27, 2013</results_first_submitted>
  <results_first_submitted_qc>February 27, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 9, 2013</results_first_posted>
  <last_update_submitted>February 27, 2013</last_update_submitted>
  <last_update_submitted_qc>February 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <recruitment_details>April 2011-April 2012 Changi General Hospital</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Ultrasound-assisted</title>
          <description>Pre-procedural ultrasound scan performed</description>
        </group>
        <group group_id="P2">
          <title>Manual Palpation</title>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ultrasound-assisted</title>
          <description>Pre-procedural ultrasound scan performed</description>
        </group>
        <group group_id="B2">
          <title>Manual Palpation</title>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="85"/>
            <count group_id="B2" value="85"/>
            <count group_id="B3" value="170"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.1" spread="13.3"/>
                    <measurement group_id="B2" value="63.7" spread="12.6"/>
                    <measurement group_id="B3" value="62.4" spread="12.9"/>
                  </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="30"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Singapore</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Success Rate of First-attempt of Spinal Anaesthesia</title>
        <time_frame>During procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound-assisted</title>
            <description>Pre-procedural ultrasound scan performed</description>
          </group>
          <group group_id="O2">
            <title>Manual Palpation</title>
          </group>
        </group_list>
        <measure>
          <title>Success Rate of First-attempt of Spinal Anaesthesia</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Taken to Perform Spinal Anaesthesia</title>
        <time_frame>During procedure</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Ultrasound-assisted</title>
          <description>Pre-procedural ultrasound scan performed</description>
        </group>
        <group group_id="E2">
          <title>Manual Palpation</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>Baseline characteristics not equal</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Lim Yean Chin</name_or_title>
      <organization>Changi General Hospital</organization>
      <phone>+65 68503831</phone>
      <email>yean_chin_lim@cgh.com.sg</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/NCT01699373
org study id: UGSA/2010
nct id: NCT01699373
lead sponsor: 
has dmc: No
A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with
      manual palpation to identify landmarks for performance of spinal anaesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Success Rate of First-attempt of Spinal Anaesthesia
time frame: During procedure
measure: Time Taken to Perform Spinal Anaesthesia
time frame: During procedure
arm group label: Ultrasound-assisted
arm group type: Experimental
description: Pre-procedural ultrasound scan performed
arm group label: Manual Palpation
arm group type: No Intervention
intervention type: Procedure
intervention name: Ultrasound scan
description: Pre-procedural ultrasound scan was performed
arm group label: Ultrasound-assisted
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Singapore
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Baseline characteristics not equal
point of contact: 