<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/NCT02994641</url>
  </required_header>
  <id_info>
    <org_study_id>2015P002568</org_study_id>
    <nct_id>NCT02994641</nct_id>
  </id_info>
  <brief_title>Critical Care Observation of Motor Activity (COMA) and SICU Outcomes</brief_title>
  <acronym>COMA</acronym>
  <official_title>Critical Care Observation of Motor Activity (COMA) - A Practicable and Valid Predictor of Patients' Outcome in the Surgical Intensive Care Unit: A Observational Study at 2 Surgical Intensive Care Units at Massachusetts General Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the surgical intensive care unit (SICU), goals of critical care are often discussed in&#xD;
      long-term ventilated patients around the time of extubation. Muscle weakness predicts&#xD;
      extubation failure but formal muscle strength assessment by the Medical Research Council&#xD;
      scale is time-consuming and not part of the daily clinical exam. In this observational study,&#xD;
      we hypothesize that COMA measurement, routinely used by the SICU nurses, is a reliable and&#xD;
      valid predictor for patients' SICU outcomes. This prospective observational study is carried&#xD;
      out within a consecutively enrolled cohort of adult patients who are extubated in two SICUs&#xD;
      at Massachusetts General Hospital, Boston.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse discharge disposition</measure>
    <time_frame>Within one day after hospital discharge</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>Time frame within 24 hours after ICU admission and within 24 hours after ICU discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Time frame within 24 hours after hospital admission and within 24 hours after hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>Within 30-days after extubation in the ICU or until the day of hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital costs</measure>
    <time_frame>Between the day of hospital admission and the day of hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day hospital readmission</measure>
    <time_frame>Within 30 days after discharge from the index hospital stay</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Validation: Receiver operating curve (ROC) analysis - Acute Physiology and Chronic Health Evaluation II</measure>
    <time_frame>At the day of admission to the ICU as well as within 72 hours after extubation</time_frame>
    <description>ROC curve of COMA compared to ROC curve of Acute Physiology and Chronic Health Evaluation (APACHE) II</description>
  </other_outcome>
  <other_outcome>
    <measure>Validation: Receiver operating curve (ROC) analysis - Charlson Comorbidity Index</measure>
    <time_frame>At the day of admission to the ICU as well as within 72 hours after extubation</time_frame>
    <description>ROC curve of COMA compared to ROC curve of Charlson Comorbidity Index (CCI)</description>
  </other_outcome>
  <other_outcome>
    <measure>Validation: Receiver operating curve (ROC) analysis - Richmond Agitation and Sedation Score</measure>
    <time_frame>Within 72 hours after extubation</time_frame>
    <description>ROC curve of COMA compared to ROC curve of Richmond Agitation and Sedation Score (RASS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Validation: Receiver operating curve (ROC) analysis - Confusion Assessment Method ICU score</measure>
    <time_frame>Within 72 hours after extubation</time_frame>
    <description>ROC curve of COMA compared to ROC curve of Confusion Assessment Method (CAM) ICU score</description>
  </other_outcome>
  <other_outcome>
    <measure>Validation: weighed kappa statistics</measure>
    <time_frame>Within 72 hours after extubation</time_frame>
    <description>Inter-rater agreement with COMA score between A.M. and P.M. shift nurse</description>
  </other_outcome>
  <other_outcome>
    <measure>Validation: correlation between COMA and actual skeletal muscle index assessed by computer tomography</measure>
    <time_frame>Within 72 hours after extubation</time_frame>
    <description>Skeletal muscle index is measured at the level of the 3rd lumbar vertebrae</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">761</enrollment>
  <condition>Motor Activity</condition>
  <condition>Muscle Strength</condition>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Adverse discharge disposition</arm_group_label>
    <description>Patients who were discharged to a skilled nursing facility or died in the hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No adverse discharge disposition</arm_group_label>
    <description>Patients who were not discharged to a skilled nursing facility or did not die in the hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>COMA Score Assessment</intervention_name>
    <arm_group_label>Adverse discharge disposition</arm_group_label>
    <arm_group_label>No adverse discharge disposition</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study cohort of adult patients who are extubated in two SICUs at Massachusetts General&#xD;
        Hospital, Boston.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intubated and mechanically ventilated patients in 2 ICUs at Massachusetts General&#xD;
             Hospital&#xD;
&#xD;
          -  adult patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tracheostomy without extubation attempt&#xD;
&#xD;
          -  Death without extubation attempt/terminal extubation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>112 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Matthias Eikermann</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>critical care</keyword>
  <keyword>patient discharge</keyword>
  <keyword>costs and cost analysis</keyword>
  <keyword>length of stay</keyword>
  <keyword>hospital mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</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/NCT02994641
org study id: 2015P002568
nct id: NCT02994641
lead sponsor: 
has dmc: No
In the surgical intensive care unit (SICU), goals of critical care are often discussed in
      long-term ventilated patients around the time of extubation. Muscle weakness predicts
      extubation failure but formal muscle strength assessment by the Medical Research Council
      scale is time-consuming and not part of the daily clinical exam. In this observational study,
      we hypothesize that COMA measurement, routinely used by the SICU nurses, is a reliable and
      valid predictor for patients' SICU outcomes. This prospective observational study is carried
      out within a consecutively enrolled cohort of adult patients who are extubated in two SICUs
      at Massachusetts General Hospital, Boston.
observational model: Cohort
time perspective: Prospective
measure: Adverse discharge disposition
time frame: Within one day after hospital discharge
measure: ICU length of stay
time frame: Time frame within 24 hours after ICU admission and within 24 hours after ICU discharge
measure: Hospital length of stay
time frame: Time frame within 24 hours after hospital admission and within 24 hours after hospital discharge
measure: 30-day mortality
time frame: Within 30-days after extubation in the ICU or until the day of hospital discharge
measure: Hospital costs
time frame: Between the day of hospital admission and the day of hospital discharge
measure: 30-day hospital readmission
time frame: Within 30 days after discharge from the index hospital stay
measure: Validation: Receiver operating curve (ROC) analysis - Acute Physiology and Chronic Health Evaluation II
time frame: At the day of admission to the ICU as well as within 72 hours after extubation
description: ROC curve of COMA compared to ROC curve of Acute Physiology and Chronic Health Evaluation (APACHE) II
measure: Validation: Receiver operating curve (ROC) analysis - Charlson Comorbidity Index
time frame: At the day of admission to the ICU as well as within 72 hours after extubation
description: ROC curve of COMA compared to ROC curve of Charlson Comorbidity Index (CCI)
measure: Validation: Receiver operating curve (ROC) analysis - Richmond Agitation and Sedation Score
time frame: Within 72 hours after extubation
description: ROC curve of COMA compared to ROC curve of Richmond Agitation and Sedation Score (RASS)
measure: Validation: Receiver operating curve (ROC) analysis - Confusion Assessment Method ICU score
time frame: Within 72 hours after extubation
description: ROC curve of COMA compared to ROC curve of Confusion Assessment Method (CAM) ICU score
measure: Validation: weighed kappa statistics
time frame: Within 72 hours after extubation
description: Inter-rater agreement with COMA score between A.M. and P.M. shift nurse
measure: Validation: correlation between COMA and actual skeletal muscle index assessed by computer tomography
time frame: Within 72 hours after extubation
description: Skeletal muscle index is measured at the level of the 3rd lumbar vertebrae
arm group label: Adverse discharge disposition
description: Patients who were discharged to a skilled nursing facility or died in the hospital
arm group label: No adverse discharge disposition
description: Patients who were not discharged to a skilled nursing facility or did not die in the hospital
intervention type: Procedure
intervention name: COMA Score Assessment
arm group label: Adverse discharge disposition
arm group label: No adverse discharge disposition
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 112 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Matthias Eikermann
investigator title: Dr.
mesh term: Muscle Weakness