<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/NCT02995811</url>
  </required_header>
  <id_info>
    <org_study_id>208134</org_study_id>
    <nct_id>NCT02995811</nct_id>
  </id_info>
  <brief_title>Characterising Changes in Muscle Quantity and Quality in Patients Requiring ECMO Oxygen During Critical Illness</brief_title>
  <acronym>ECMO USS</acronym>
  <official_title>Characterising Changes in Muscle Quantity and Quality in Patients Requiring Extracorporeal Membrane Oxygen During Critical Illness: 'ECMO-Ultrasound', An Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Euro-ELSO</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will identify the changes in different muscles of patients receiving&#xD;
      Extracorporeal Membrane Oxygenation (ECMO) during critical illness and admission to Intensive&#xD;
      Care Unit (ICU). The information will help guide development of treatments such as exercise&#xD;
      that may help to reduce the amount of muscle wasting that can occur during critical illness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Admission to the intensive care unit (ICU) with critical illness is typically associated with&#xD;
      profound physical impairments including peripheral skeletal muscle wasting and dysfunction.&#xD;
      These effects demonstrate a rapid onset from the point of ICU admission, affect those with&#xD;
      higher illness acuity to greater levels, and contribute to the development of intensive care&#xD;
      unit-acquired weakness (ICU-AW) defined as severe upper and lower limb muscle weakness.&#xD;
&#xD;
      Muscle structure has traditionally been evaluated using complex scanning approaches such as&#xD;
      computed tomography or dual energy x-ray absorptiometry, however there are a number of&#xD;
      caveats to their use in the clinical environment of critical care. Ionising radiation&#xD;
      involved precludes their use in large populations, and especially for performance of&#xD;
      sequential measurements. Whilst magnetic resonance imaging avoids this concern, practical&#xD;
      limitations exist around scanning time and accessibility. In addition, all these imaging&#xD;
      modalities require transfer out of the ICU environment, further restricting their application&#xD;
      to acutely unwell, unstable patients. Finally, in addition to their expense, the nature of&#xD;
      imaging using these approaches means that only a limited number of muscles may be assessed at&#xD;
      any one time.&#xD;
&#xD;
      Ultrasound has emerged in recent years as a technique with significant clinical utility for&#xD;
      assessing and monitoring the trajectory of change in muscle during acute critical illness. A&#xD;
      range of parameters of muscle architecture and quality can be measured and data from the&#xD;
      critical illness population is growing. Advantages of ultrasound include feasibility of&#xD;
      bedside assessment, and that is it non-ionising, non-invasive and effort-independent with&#xD;
      equipment is readily available in the critical care environment. Ultrasound imaging has&#xD;
      robust clinimetric properties and predictive utility for morbidity and other clinical&#xD;
      endpoints including mortality and hospital readmission.&#xD;
&#xD;
      A number of observational cohort studies have conducted sequential measurements of a range of&#xD;
      respiratory and peripheral skeletal muscle groups during critical illness, characterising the&#xD;
      decline in both muscle quantity and quality as a result of the acute insult. However no&#xD;
      studies to date have included assessment of the abdominal muscles in critically ill patients&#xD;
      necessary for core stability, trunk control and postural maintenance and therefore of&#xD;
      significant clinical importance during the rehabilitation process.&#xD;
&#xD;
      In addition, whilst hypoxia has been found to be associated with greater muscle attenuation,&#xD;
      no study has examined the relative changes in muscle in patients receiving extracorporeal&#xD;
      membrane oxygenation (ECMO). ECMO is a ventilator support therapy primarily delivered to&#xD;
      critically ill patients with severe respiratory failure where the hypoxic state is corrected.&#xD;
&#xD;
      The aim of this study is therefore to characterise sequential changes across respiratory,&#xD;
      trunk and peripheral skeletal muscles in critically ill patients requiring ECMO.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sequential changes in parameters of muscle architecture of the muscles in critically ill patients requiring ECMO by Ultrasound</measure>
    <time_frame>10 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Sequential changes in quality of the muscles in critically ill patients requiring ECMO by Ultrasound</measure>
    <time_frame>10 Days</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Critical Illness</condition>
  <condition>Intensive Care Units</condition>
  <condition>Extracorporeal Membrane Oxygenation</condition>
  <arm_group>
    <arm_group_label>Observational Cohort</arm_group_label>
    <description>On Days 1, 3, 7 and 10 of ICU admission, patients will undergo ultrasound assessment of the diaphragm, transverse and rectus abdominis, quadriceps rectus femoris, and tibialis anterior muscles. Imaging all four muscles together requires approximately 1 hour.&#xD;
Physical activity monitoring: On Days 1-10 of ICU admission patients will wear an activity monitor. These devices use several inertial motion sensors to track the movement and acceleration of the limbs in horizontal and vertical directions.&#xD;
Patients will also undergo daily assessment of global peripheral skeletal muscle strength assessed by the Medical Research Council Sum-score and global function measured by the Chelsea Critical Care Physical Assessment Scale</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational Cohort</intervention_name>
    <description>Ultrasound assessment of 4 muscles, activity monitoring, daily global peripheral skeletal muscle strength</description>
    <arm_group_label>Observational Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult critically ill patients admitted to the ICU with critical illness requiring ECMO&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult, ≥18years&#xD;
&#xD;
          -  Requiring ECMO for management of severe respiratory failure&#xD;
&#xD;
          -  Likely to remain in the ICU for 10days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Neurological injury e.g. stroke, acquired brain injury&#xD;
&#xD;
          -  Trauma injury e.g. amputation, multiple fractures&#xD;
&#xD;
          -  Clinical presentation precluding ultrasound imaging of muscle at the time of&#xD;
             assessment&#xD;
&#xD;
          -  Not expected to survive more than 24 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nick Barrett</last_name>
    <role>Study Chair</role>
    <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guys and St Thomas NHS Foundation</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share individual participant data</ipd_description>
  </patient_data>
  <!-- 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/NCT02995811
org study id: 208134
nct id: NCT02995811
lead sponsor: 
collaborator: 
has dmc: No
This study will identify the changes in different muscles of patients receiving
      Extracorporeal Membrane Oxygenation (ECMO) during critical illness and admission to Intensive
      Care Unit (ICU). The information will help guide development of treatments such as exercise
      that may help to reduce the amount of muscle wasting that can occur during critical illness.
Admission to the intensive care unit (ICU) with critical illness is typically associated with
      profound physical impairments including peripheral skeletal muscle wasting and dysfunction.
      These effects demonstrate a rapid onset from the point of ICU admission, affect those with
      higher illness acuity to greater levels, and contribute to the development of intensive care
      unit-acquired weakness (ICU-AW) defined as severe upper and lower limb muscle weakness.

      Muscle structure has traditionally been evaluated using complex scanning approaches such as
      computed tomography or dual energy x-ray absorptiometry, however there are a number of
      caveats to their use in the clinical environment of critical care. Ionising radiation
      involved precludes their use in large populations, and especially for performance of
      sequential measurements. Whilst magnetic resonance imaging avoids this concern, practical
      limitations exist around scanning time and accessibility. In addition, all these imaging
      modalities require transfer out of the ICU environment, further restricting their application
      to acutely unwell, unstable patients. Finally, in addition to their expense, the nature of
      imaging using these approaches means that only a limited number of muscles may be assessed at
      any one time.

      Ultrasound has emerged in recent years as a technique with significant clinical utility for
      assessing and monitoring the trajectory of change in muscle during acute critical illness. A
      range of parameters of muscle architecture and quality can be measured and data from the
      critical illness population is growing. Advantages of ultrasound include feasibility of
      bedside assessment, and that is it non-ionising, non-invasive and effort-independent with
      equipment is readily available in the critical care environment. Ultrasound imaging has
      robust clinimetric properties and predictive utility for morbidity and other clinical
      endpoints including mortality and hospital readmission.

      A number of observational cohort studies have conducted sequential measurements of a range of
      respiratory and peripheral skeletal muscle groups during critical illness, characterising the
      decline in both muscle quantity and quality as a result of the acute insult. However no
      studies to date have included assessment of the abdominal muscles in critically ill patients
      necessary for core stability, trunk control and postural maintenance and therefore of
      significant clinical importance during the rehabilitation process.

      In addition, whilst hypoxia has been found to be associated with greater muscle attenuation,
      no study has examined the relative changes in muscle in patients receiving extracorporeal
      membrane oxygenation (ECMO). ECMO is a ventilator support therapy primarily delivered to
      critically ill patients with severe respiratory failure where the hypoxic state is corrected.

      The aim of this study is therefore to characterise sequential changes across respiratory,
      trunk and peripheral skeletal muscles in critically ill patients requiring ECMO.
observational model: Cohort
time perspective: Prospective
measure: Sequential changes in parameters of muscle architecture of the muscles in critically ill patients requiring ECMO by Ultrasound
time frame: 10 days
measure: Sequential changes in quality of the muscles in critically ill patients requiring ECMO by Ultrasound
time frame: 10 Days
arm group label: Observational Cohort
description: On Days 1, 3, 7 and 10 of ICU admission, patients will undergo ultrasound assessment of the diaphragm, transverse and rectus abdominis, quadriceps rectus femoris, and tibialis anterior muscles. Imaging all four muscles together requires approximately 1 hour.
Physical activity monitoring: On Days 1-10 of ICU admission patients will wear an activity monitor. These devices use several inertial motion sensors to track the movement and acceleration of the limbs in horizontal and vertical directions.
Patients will also undergo daily assessment of global peripheral skeletal muscle strength assessed by the Medical Research Council Sum-score and global function measured by the Chelsea Critical Care Physical Assessment Scale
intervention type: Other
intervention name: Observational Cohort
description: Ultrasound assessment of 4 muscles, activity monitoring, daily global peripheral skeletal muscle strength
arm group label: Observational Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nick Barrett
role: Study Chair
affiliation: Guy's and St Thomas' NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: No
ipd description: No plan to share individual participant data