<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/NCT02990871</url>
  </required_header>
  <id_info>
    <org_study_id>tracheostomy_01</org_study_id>
    <nct_id>NCT02990871</nct_id>
  </id_info>
  <brief_title>Efficacy of an Early Rehabilitation on Decannulation Time of Patients With Severe Acquired Brain Injury</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale Generale Di Zona Moriggia-Pelascini</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale Generale Di Zona Moriggia-Pelascini</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      All the patients hospitalized in the neuro-rehabilitation after a severe acquired brain&#xD;
      injury carrying a tracheal cannula will be retrospectively analyzed. Patients coming from&#xD;
      emergency department started a rehabilitative treatment during their hospitalization in ICU.&#xD;
      Patients transferred from an external ICU started the rehabilitation in neurorehabilitation&#xD;
      department. Aim of the study is to evaluate if an early rehabilitation, started since the&#xD;
      acute stage of the damage, is able to reduce the decannulation time in this group of&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2016</start_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>decannulation time</measure>
    <time_frame>at data collecting, an average of 1 day</time_frame>
    <description>number days between tracheostomy positioning and removal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of stay ICU</measure>
    <time_frame>at data collecting, an average of 1 day</time_frame>
    <description>number days between admission and discharge from ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>decannulation time in NRiab</measure>
    <time_frame>at data collecting, an average of 1 day</time_frame>
    <description>number days between NRehab admission and decannulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coma Recovery Scale revised score at discharge</measure>
    <time_frame>at data collecting, an average of 1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glasgow Coma Scale score at discharge</measure>
    <time_frame>at data collecting, an average of 1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability Rating Scale Score at discharge</measure>
    <time_frame>at data collecting, an average of 1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of Cognitive Functioning score at discharge</measure>
    <time_frame>at data collecting, an average of 1 day</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Brain Injury</condition>
  <condition>Tracheostomy</condition>
  <condition>Neurological Rehabilitation</condition>
  <arm_group>
    <arm_group_label>early rehabilitation</arm_group_label>
    <description>Patients started rehabilitative treatment during ICU hospitalization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no-early rehabilitation</arm_group_label>
    <description>Patients started rehabilitative treatment after admission in Neuro-rehabilitation department</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>early neurological rehabilitation</intervention_name>
    <description>start of neurological rehabilitation between 3rd and 15th day after ABI</description>
    <arm_group_label>early rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no-early neurological rehabilitation</intervention_name>
    <description>start of neurological rehabilitation between 20th and 90th day after ABI</description>
    <arm_group_label>no-early rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with tracheostomy, affected by severe acquired brain injury, hospitalized in our&#xD;
        Neurorehabilitation department.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of a tracheostomy at admission in NRehab&#xD;
&#xD;
          -  patient moved from an ICU&#xD;
&#xD;
          -  GCS≤11 at admission in ICU&#xD;
&#xD;
          -  tracheostomy performed for decreased mental status due to the ABI,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  tracheostomy performed prior to admission to the ICU&#xD;
&#xD;
          -  need for ventilation support.&#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>Ospedale Generale di Zona Moriggia Pelascini</name>
      <address>
        <city>Gravedona ed Uniti</city>
        <state>CO</state>
        <zip>22015</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ospedale Generale Di Zona Moriggia-Pelascini</investigator_affiliation>
    <investigator_full_name>Ilaria Zivi</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</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/NCT02990871
org study id: tracheostomy_01
nct id: NCT02990871
lead sponsor: 
has dmc: No
All the patients hospitalized in the neuro-rehabilitation after a severe acquired brain
      injury carrying a tracheal cannula will be retrospectively analyzed. Patients coming from
      emergency department started a rehabilitative treatment during their hospitalization in ICU.
      Patients transferred from an external ICU started the rehabilitation in neurorehabilitation
      department. Aim of the study is to evaluate if an early rehabilitation, started since the
      acute stage of the damage, is able to reduce the decannulation time in this group of
      patients.
observational model: Case-Control
time perspective: Retrospective
measure: decannulation time
time frame: at data collecting, an average of 1 day
description: number days between tracheostomy positioning and removal
measure: length of stay ICU
time frame: at data collecting, an average of 1 day
description: number days between admission and discharge from ICU
measure: decannulation time in NRiab
time frame: at data collecting, an average of 1 day
description: number days between NRehab admission and decannulation
measure: Coma Recovery Scale revised score at discharge
time frame: at data collecting, an average of 1 day
measure: Glasgow Coma Scale score at discharge
time frame: at data collecting, an average of 1 day
measure: Disability Rating Scale Score at discharge
time frame: at data collecting, an average of 1 day
measure: Levels of Cognitive Functioning score at discharge
time frame: at data collecting, an average of 1 day
arm group label: early rehabilitation
description: Patients started rehabilitative treatment during ICU hospitalization
arm group label: no-early rehabilitation
description: Patients started rehabilitative treatment after admission in Neuro-rehabilitation department
intervention type: Other
intervention name: early neurological rehabilitation
description: start of neurological rehabilitation between 3rd and 15th day after ABI
arm group label: early rehabilitation
intervention type: Other
intervention name: no-early neurological rehabilitation
description: start of neurological rehabilitation between 20th and 90th day after ABI
arm group label: no-early rehabilitation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Ospedale Generale Di Zona Moriggia-Pelascini
investigator full name: Ilaria Zivi
investigator title: MD
mesh term: Brain Injuries