<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/NCT04412356</url>
  </required_header>
  <id_info>
    <org_study_id>HBergquist</org_study_id>
    <nct_id>NCT04412356</nct_id>
  </id_info>
  <brief_title>Timing of Tracheotomy in Covid-19 Patients</brief_title>
  <acronym>TTCOV19</acronym>
  <official_title>Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Critically ill covid-19 patients may require respiratory support including mechanical&#xD;
      ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in&#xD;
      order to reduce potential airway complications, reduce the need of sedation and facilitate&#xD;
      the monitoring and recovery. The optimal timing of this surgical procedure is, however, still&#xD;
      unknown. The aim of this randomized, controlled trial is to compare the outcome of early&#xD;
      (within 7 days after intubation) vs late (at least 10 days after intubation) tracheotomy in&#xD;
      covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support,&#xD;
      frequency of complications, duration at the ICU and mortality through the ICU stay will be&#xD;
      evaluated and compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2020</start_date>
  <completion_date type="Actual">September 20, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</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>
    <intervention_model_description>Randomized, single blinded, controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients will be blinded to the randomization outcome.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mechanical ventilation</measure>
    <time_frame>Through the individual ICU stay assessed up to 60 days</time_frame>
    <description>Number of days with mechanical ventilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>Through the individual ICU stay assessed up to 60 days</time_frame>
    <description>Number of days at ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen support</measure>
    <time_frame>Through the individual ICU stay assessed up to 60 days</time_frame>
    <description>Number of days with need of additional oxygen support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation</measure>
    <time_frame>Through the individual ICU stay assessed up to 60 days</time_frame>
    <description>Number of days with the need of sedation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Through the individual ICU stay assessed up to 60 days</time_frame>
    <description>Various adverse events associated with the tracheotomy/tracheostomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Through the individual ICU stay assessed up to 90 days</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Covid-19</condition>
  <condition>ARDS</condition>
  <condition>Tracheostomy Complication</condition>
  <condition>Respiratory Insufficiency</condition>
  <condition>Corona Virus Infection</condition>
  <arm_group>
    <arm_group_label>Early tracheotomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tracheotomy within 7 days after intubation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late tracheotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tracheotomy after at least 10 days after intubation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tracheotomy</intervention_name>
    <description>Surgical procedure to secure airway</description>
    <arm_group_label>Early tracheotomy</arm_group_label>
    <arm_group_label>Late tracheotomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Verified Covid-19 infection&#xD;
&#xD;
          -  Intubated due to respiratory insufficiency and need for mechanical ventilation&#xD;
&#xD;
          -  Informed consent from patient or relative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18 years&#xD;
&#xD;
          -  Need for mechanical ventilation less than 14 days&#xD;
&#xD;
          -  Tracheotomy not possible within 7 days&#xD;
&#xD;
          -  Tracheotomy not possible due to anatomical or other medical reasons&#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>Henrik Bergquist, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sahlgrenska University Hospital, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Henrik Bergquist</investigator_full_name>
    <investigator_title>MD, PhD, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Covid-19</keyword>
  <keyword>Tracheotomy</keyword>
  <keyword>Tracheostomy</keyword>
  <keyword>RCT</keyword>
  <keyword>ARDS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Respiratory Insufficiency</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/NCT04412356
org study id: HBergquist
nct id: NCT04412356
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Critically ill covid-19 patients may require respiratory support including mechanical
      ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in
      order to reduce potential airway complications, reduce the need of sedation and facilitate
      the monitoring and recovery. The optimal timing of this surgical procedure is, however, still
      unknown. The aim of this randomized, controlled trial is to compare the outcome of early
      (within 7 days after intubation) vs late (at least 10 days after intubation) tracheotomy in
      covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support,
      frequency of complications, duration at the ICU and mortality through the ICU stay will be
      evaluated and compared.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, single blinded, controlled trial
primary purpose: Treatment
masking: Single (Participant)
masking description: Patients will be blinded to the randomization outcome.
measure: Mechanical ventilation
time frame: Through the individual ICU stay assessed up to 60 days
description: Number of days with mechanical ventilation
measure: ICU stay
time frame: Through the individual ICU stay assessed up to 60 days
description: Number of days at ICU
measure: Oxygen support
time frame: Through the individual ICU stay assessed up to 60 days
description: Number of days with need of additional oxygen support
measure: Sedation
time frame: Through the individual ICU stay assessed up to 60 days
description: Number of days with the need of sedation
measure: Adverse events
time frame: Through the individual ICU stay assessed up to 60 days
description: Various adverse events associated with the tracheotomy/tracheostomy
measure: Mortality
time frame: Through the individual ICU stay assessed up to 90 days
description: Mortality
arm group label: Early tracheotomy
arm group type: Experimental
description: Tracheotomy within 7 days after intubation.
arm group label: Late tracheotomy
arm group type: Active Comparator
description: Tracheotomy after at least 10 days after intubation.
intervention type: Procedure
intervention name: Tracheotomy
description: Surgical procedure to secure airway
arm group label: Early tracheotomy
arm group label: Late tracheotomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Henrik Bergquist, Assoc Prof
role: Principal Investigator
affiliation: Sahlgrenska University Hospital, Sweden
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Henrik Bergquist
investigator title: MD, PhD, Associate Professor
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Respiratory Insufficiency