xml: <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/NCT06018220</url>
    </required_header>
    <id_info>
      <org_study_id>NEU6021</org_study_id>
      <nct_id>NCT06018220</nct_id>
    </id_info>
    <brief_title>Percutaneous Dilatational Tracheostomy vs. Surgical Tracheostomy in Neurocritically Ill Patients - a Retrospective Study</brief_title>
    <official_title>Percutaneous Dilatational Tracheostomy vs. Surgical Tracheostomy in Neurocritically Ill Patients - a Retrospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rigshospitalet, Denmark</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rigshospitalet, Denmark</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The aim of the present quality study is to examine the relationship between choice of&#xD;
        tracheotomy procedure and complications in a neurocritically ill patient population at a&#xD;
        single center. Secondary outcomes are the influence of clinician skill level (for PDTs), time&#xD;
        from admission to tracheostomy, length of stay and time to decannulation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Neurocritically ill patients often require placement of a tracheostomy at some point during&#xD;
        admission, as impaired consciousness and insufficient protective airway reflexes often make&#xD;
        weaning from mechanical ventilation prolonged.&#xD;
  &#xD;
        Percutaneous dilatational tracheostomy (PDT) with fiberoptic visualization can be performed&#xD;
        bedside by neurointensivists or residents under supervision, unless there are&#xD;
        contraindications. However, concerns regarding tracheal stenosis following PDT have been&#xD;
        raised. This a rare complication but when it occurs it is a severe long-term complication,&#xD;
        and the patients are often in need of repeated interventions. The alternative is surgical&#xD;
        tracheostomy (ST) which is more resource intensive but perceived as safer in high risk&#xD;
        patients. The indication for tracheostomy (and the choice of procedure) is ultimately based&#xD;
        on judgement of clinical team.&#xD;
  &#xD;
        Systematic reviews have found no difference between PDT and ST regarding severe&#xD;
        complications, apart from a higher incidence of wound infections after ST. However, a higher&#xD;
        incidence of complications following PDT has been reported when residents are performing the&#xD;
        procedure, suggesting an influence of physician skill level.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        This is a retrospective observational single-center quality study. All patients &gt; 18 years of&#xD;
        age admitted to the Neurointensive Care Unit at Rigshospitalet, Copenhagen between January&#xD;
        2018 and December 2022 with a registered procedure code for either PDT or ST wil be included.&#xD;
        Approval from departmental leadership and The Judicial Department at Rigshopitalet has been&#xD;
        attained. Data will be extracted from the electronical medical records and any short (&lt; 1&#xD;
        week) or long-term complications will be registered. The follow-up period is 6 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 27, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 20, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients with complications following tracheostomy</measure>
      <time_frame>Up to 1 week after tracheostomy procedure</time_frame>
      <description>Bleeding; pneumothorax, pneumomediastinum, lost airway, via falsa, procedure-related death, other.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with complications following tracheostomy - long term.</measure>
      <time_frame>From 1 week up to 6 months after the tracheostomy procedure</time_frame>
      <description>Tracheal stenosis, fistula, wound infection, accidental decannulation, scarring, delayed wound healing, changes in voice or speech, other.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of complications according to the skilled level of the clinician performing the tracheostomy (only for percutaneous dilatational tracheostomy)</measure>
      <time_frame>Up to 6 months following tracheostomy</time_frame>
      <description>Non-skilled residents vs. senior physician</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Time from admission to tracheostomy, time to decannulation, time to discharge from ICU/hospital</description>
    </secondary_outcome>
    <enrollment type="Anticipated">383</enrollment>
    <condition>Tracheostomy Complication</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patientiens in Neurointensive Care. Diagnosis are: Traumatic brain injury,&#xD;
          intracranial haemorrhage, subarachoid haemorrahge, spinal cord injury, guillian barre,&#xD;
          myastenia gravis, status epilepticus, postoperative conditions.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients admitted to Neurointensive Care Unit, Rigshospitalet, Denmark AND having a&#xD;
          tracheostomy performed during their stay.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Children - age &lt; 18.&#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>Martin K Soerensen, PHD</last_name>
      <role>Study Chair</role>
      <affiliation>Department of Neruoanaesthesiology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Birgitte Majholm, PHD</last_name>
      <phone>+45 35451857</phone>
      <email>Birgitte.Majholm.01@regionh.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Martin K Soerensen, PHD</last_name>
      <phone>+ 45 3545 7009</phone>
      <email>Martin.Kryspin.Soerensen.01@regionh.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rigshospitalet</name>
        <address>
          <city>Copenhagen</city>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Birgitte Majholm, PHD</last_name>
        <phone>+45 35451857</phone>
        <email>Birgitte.Majholm.01@regionh.dk</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
      <investigator_full_name>Birgitte Majholm</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018220
  org study id: NEU6021
  nct id: NCT06018220
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the present quality study is to examine the relationship between choice of
        tracheotomy procedure and complications in a neurocritically ill patient population at a
        single center. Secondary outcomes are the influence of clinician skill level (for PDTs), time
        from admission to tracheostomy, length of stay and time to decannulation.
  Neurocritically ill patients often require placement of a tracheostomy at some point during
        admission, as impaired consciousness and insufficient protective airway reflexes often make
        weaning from mechanical ventilation prolonged.
  
        Percutaneous dilatational tracheostomy (PDT) with fiberoptic visualization can be performed
        bedside by neurointensivists or residents under supervision, unless there are
        contraindications. However, concerns regarding tracheal stenosis following PDT have been
        raised. This a rare complication but when it occurs it is a severe long-term complication,
        and the patients are often in need of repeated interventions. The alternative is surgical
        tracheostomy (ST) which is more resource intensive but perceived as safer in high risk
        patients. The indication for tracheostomy (and the choice of procedure) is ultimately based
        on judgement of clinical team.
  
        Systematic reviews have found no difference between PDT and ST regarding severe
        complications, apart from a higher incidence of wound infections after ST. However, a higher
        incidence of complications following PDT has been reported when residents are performing the
        procedure, suggesting an influence of physician skill level.
  
        Methods:
  
        This is a retrospective observational single-center quality study. All patients > 18 years of
        age admitted to the Neurointensive Care Unit at Rigshospitalet, Copenhagen between January
        2018 and December 2022 with a registered procedure code for either PDT or ST wil be included.
        Approval from departmental leadership and The Judicial Department at Rigshopitalet has been
        attained. Data will be extracted from the electronical medical records and any short (< 1
        week) or long-term complications will be registered. The follow-up period is 6 months.
  observational model: Cohort
  time perspective: Retrospective
  measure: Number of patients with complications following tracheostomy
  time frame: Up to 1 week after tracheostomy procedure
  description: Bleeding; pneumothorax, pneumomediastinum, lost airway, via falsa, procedure-related death, other.
  measure: Number of patients with complications following tracheostomy - long term.
  time frame: From 1 week up to 6 months after the tracheostomy procedure
  description: Tracheal stenosis, fistula, wound infection, accidental decannulation, scarring, delayed wound healing, changes in voice or speech, other.
  measure: Number of complications according to the skilled level of the clinician performing the tracheostomy (only for percutaneous dilatational tracheostomy)
  time frame: Up to 6 months following tracheostomy
  description: Non-skilled residents vs. senior physician
  measure: Days
  time frame: Up to 6 months
  description: Time from admission to tracheostomy, time to decannulation, time to discharge from ICU/hospital
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Martin K Soerensen, PHD
  role: Study Chair
  affiliation: Department of Neruoanaesthesiology
  last name: Birgitte Majholm, PHD
  phone: +45 35451857
  email: Birgitte.Majholm.01@regionh.dk
  last name: Martin K Soerensen, PHD
  phone: + 45 3545 7009
  email: Martin.Kryspin.Soerensen.01@regionh.dk
  facility: 
  status: Recruiting
  contact: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Rigshospitalet, Denmark
  investigator full name: Birgitte Majholm
  investigator title: Principal Investigator
  sharing ipd: No