<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/NCT02996526</url>
  </required_header>
  <id_info>
    <org_study_id>SSMGAD2016</org_study_id>
    <nct_id>NCT02996526</nct_id>
  </id_info>
  <brief_title>The Incidence and Impact of Vocal Cord Dysfunction In Patients Undergoing Thoracic Surgery</brief_title>
  <official_title>The Incidence and Impact of Vocal Cord Dysfunction In Patients Undergoing Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Population-based single centre, blinded, prospective cohort study of the impact of recurrent&#xD;
      laryngeal nerve (RLN) injury on Thoracic Surgery patients. The principal outcome of interest&#xD;
      is the effect of RLN injury on respiratory complications. Voice, swallowing, cardiac and&#xD;
      mortality outcomes will also be determined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
      Primary: Estimate the prevalence of vocal cord dysfunction after thoracic surgery and the&#xD;
      association of vocal cord dysfunction and immediate post operative respiratory complication&#xD;
      after thoracic surgery.&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        1. Estimate the prevalence of vocal cord dysfunction in the pre-operative patient&#xD;
           population undergoing thoracic surgery, i.e. the baseline prevalence.&#xD;
&#xD;
        2. Estimate the incidence of new vocal cord dysfunction in the post-operative period, i.e.&#xD;
           the incidence of new dysfunction&#xD;
&#xD;
        3. Estimate the association of vocal cord dysfunction and respiratory, voice, swallowing,&#xD;
           and mortality outcomes&#xD;
&#xD;
        4. Estimate the impact of vocal cord immobility on hospital length of stay, ICU admission&#xD;
           rates and duration&#xD;
&#xD;
      Population: All patients undergoing thoracic surgery at Health Sciences Centre in Winnipeg,&#xD;
      Canada. This is a tertiary care centre with a population-based referral base of 1.5 million&#xD;
      people&#xD;
&#xD;
      Schematic of Study Design:&#xD;
&#xD;
      Enrollment Vocal Cord Mobility Assessment 1&#xD;
&#xD;
      Total N=141: Obtain informed consent. Screen potential participants by inclusion and&#xD;
      exclusion criteria; obtain history Perform Flexible Nasolaryngoscopy by otolaryngology&#xD;
      resident, document by videorecording&#xD;
&#xD;
      Vocal Cord Mobility Assessment 2 Post operative day 1-2 Perform Flexible Nasolaryngoscopy by&#xD;
      otolaryngology resident, document by videorecording&#xD;
&#xD;
      Collection of functional outcomes Hospital Discharge or Death Collection of data on&#xD;
      respiratory, voice, swallowing, cardiovascular mortality outcomes, hospital length of stay&#xD;
      and ICU admission duration&#xD;
&#xD;
      Review of Vocal Cord Mobility Assessment by expert (Laryngologist) by review of&#xD;
      videorecordings of nasolaryngoscopy&#xD;
&#xD;
      Statistical Analysis Final Assessments Association of vocal cord immobility and functional&#xD;
      outcomes and death.&#xD;
&#xD;
      2.1 Background Information Research Question: In patients undergoing thoracic surgery, what&#xD;
      is the incidence of respiratory and associated complications in the 30 day post-operative&#xD;
      period among those with/without Recurrent Laryngeal Nerve (RLN) Injury?&#xD;
&#xD;
      Background: The issue of RLN injury is an important clinical challenge in thoracic surgery,&#xD;
      as respiratory complications are the greatest source of morbidity in our surgical population&#xD;
      . Clinical care experience and the literature demonstrate a high incidence of respiratory&#xD;
      complications (20-60% incidence of pneumonia for esophagectomy and a 20% death rate for those&#xD;
      who contract pneumonia) in the post-operative thoracic surgery population.&#xD;
&#xD;
      The thoracic surgery population is at uniquely elevated risk for respiratory complications&#xD;
      due to the high prevalence of COPD, the nature of the primary surgical procedure directly&#xD;
      diminishing pulmonary function and toilet; and possible RLN injury. The only modifiable&#xD;
      element of this triad is RLN injury, and appears to be the most important element based on&#xD;
      clinical experience and the limited literature available. The RLN supplies motor innervation&#xD;
      to the vocal cords; vocal cord closure is considered the most important protective mechanism&#xD;
      against aspiration into the lungs . Patients with a RLN injury demonstrate a 5-fold risk of&#xD;
      contracting pneumonia, a 5-fold risk of reintubation or tracheostomy , and have 40-60% longer&#xD;
      hospital stays than patients without RLN injury.&#xD;
&#xD;
      The current literature base is substantially lacking with regards to the incidence of RLN&#xD;
      injury, with estimates varying from 4-80% based on retrospective reviews or prospective&#xD;
      studies which fail to examine all patients. The highest quality studies demonstrate a RLN&#xD;
      injury rate in the range of 20-40% for major procedures such as esophagectomy and&#xD;
      pneumonectomy.&#xD;
&#xD;
      With the recent advent of injection laryngoplasty for vocal cord medialization, there is now&#xD;
      a practical means of potentially altering the course of this pathologic triad. This procedure&#xD;
      can be performed at the bedside under local anesthetic, allowing for early intervention in&#xD;
      this high-risk population as a bulwark against aspiration.&#xD;
&#xD;
      Prospectively examining the incidence of pre and post-operative vocal cord immobility in all&#xD;
      thoracic surgery patients is the only means to quantify the health burden associated with RLN&#xD;
      injury.&#xD;
&#xD;
      Potential Risks Potential risks of the study include time involved in considering&#xD;
      participation, providing consent and data such as subjective voice quality and undergoing&#xD;
      flexible nasolaryngoscopy to assess vocal cord status. No health, economic or legal risks are&#xD;
      anticipated for the participants.&#xD;
&#xD;
      Potential Benefits No direct benefit, either monetary or health improvement will accrue to&#xD;
      patients from participation in the study.&#xD;
&#xD;
      Study Outcome Measures Vocal Cord Mobility - Flexible nasolaryngoscopy to visualize mobility&#xD;
      status of vocal cords.&#xD;
&#xD;
      Voice - Voice Handicap Index 10. Validated instrument used for subjective assessment of&#xD;
      voice, 10 plain language questions answered by the patient.&#xD;
&#xD;
      Respiratory: Incidence of pneumonia (as defined by CDC criteria) and intubation Swallowing:&#xD;
      Oral diet vs NPO and diet texture tolerated at discharge Cardiovascular: Myocardial&#xD;
      Infarction as defined by the third universal criteria 2012 by third ESC/ACCF/AHA/WHF,&#xD;
      Cerebrovascular Accident as defined by WHO MONICA criteria and Neurology specialist&#xD;
      consultation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">April 7, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy on the first post-operative day</measure>
    <time_frame>Post-operative day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with respiratory complictions</measure>
    <time_frame>Within 30 days of operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy prior to operation</measure>
    <time_frame>Day of operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>From date of primary operation to discharge</time_frame>
    <description>Number of days between admission to hospital and discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of patients with swallowing difficulties, cardiac complications and who have died</measure>
    <time_frame>From the date of operation to day 30 after operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>From date of operation to discharge from hospital</time_frame>
    <description>The total number of days admitted to the intensive care unit (a facility where full ventilator support and inotropic support can be provided) If more than one admission episode to the ICU, the total number of days in the ICU census is counted across the multiple admission episodes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission to hospital</measure>
    <time_frame>From day of surgery to day 90 after operation</time_frame>
    <description>Number of readmission episodes after initial discharge and during the 90 day period after surgery</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">173</enrollment>
  <condition>Vocal Cord Paresis</condition>
  <condition>Acquired Vocal Cord Palsy</condition>
  <arm_group>
    <arm_group_label>Intact Vocal Cord Mobility</arm_group_label>
    <description>Patients with normal laryngeal function post thoracic surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vocal Cord Dysfunction</arm_group_label>
    <description>Patients with abnormal vocal cord movement of 1 or both vocal cords post thoracic surgery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing thoracic surgery at Health Sciences Centre in Winnipeg, Canada.&#xD;
        This is a tertiary care centre with a population-based referral base of 1.5 million people.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing thoracic surgery at Health Sciences Centre Winnipeg.&#xD;
             Recruitment will be performed by the thoracic surgeon faculty within the Division of&#xD;
             Thoracic Surgery. Written informed consent will be obtained from the patient by an&#xD;
             independent research assistant.&#xD;
&#xD;
        In order to be eligible to participate in this study, an individual must meet all of the&#xD;
        following criteria:&#xD;
&#xD;
          -  Provide signed and dated informed consent form.&#xD;
&#xD;
          -  Willing to comply with all study procedures and be available for the duration of the&#xD;
             study.&#xD;
&#xD;
          -  Male or female, aged 18 and over..&#xD;
&#xD;
          -  Have a condition requiring surgical entry into the thoracic cavity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All individuals meeting any of the exclusion criteria at baseline will be excluded&#xD;
             from the study. Patients with severely deviated nasal anatomy precluding flexible&#xD;
             nasolaryngoscopy Tracheostomy in situ Neurologic or developmental deficits impairing&#xD;
             the ability to consent or cooperate with examination&#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>Sadeesh Srinathan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Sciences Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>January 29, 2020</last_update_submitted>
  <last_update_submitted_qc>January 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Sadeesh Srinathan, MD</investigator_full_name>
    <investigator_title>Dr. Sadeesh Srinathan Associate Professor Section of Thoracic Surgery</investigator_title>
  </responsible_party>
  <keyword>vocal cord palsy dysfunction thoracic surgery complication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vocal Cord Dysfunction</mesh_term>
    <mesh_term>Vocal Cord Paralysis</mesh_term>
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02996526
org study id: SSMGAD2016
nct id: NCT02996526
lead sponsor: 
has dmc: No
Population-based single centre, blinded, prospective cohort study of the impact of recurrent
      laryngeal nerve (RLN) injury on Thoracic Surgery patients. The principal outcome of interest
      is the effect of RLN injury on respiratory complications. Voice, swallowing, cardiac and
      mortality outcomes will also be determined.
Objectives:

      Primary: Estimate the prevalence of vocal cord dysfunction after thoracic surgery and the
      association of vocal cord dysfunction and immediate post operative respiratory complication
      after thoracic surgery.

      Secondary:

        1. Estimate the prevalence of vocal cord dysfunction in the pre-operative patient
           population undergoing thoracic surgery, i.e. the baseline prevalence.

        2. Estimate the incidence of new vocal cord dysfunction in the post-operative period, i.e.
           the incidence of new dysfunction

        3. Estimate the association of vocal cord dysfunction and respiratory, voice, swallowing,
           and mortality outcomes

        4. Estimate the impact of vocal cord immobility on hospital length of stay, ICU admission
           rates and duration

      Population: All patients undergoing thoracic surgery at Health Sciences Centre in Winnipeg,
      Canada. This is a tertiary care centre with a population-based referral base of 1.5 million
      people

      Schematic of Study Design:

      Enrollment Vocal Cord Mobility Assessment 1

      Total N=141: Obtain informed consent. Screen potential participants by inclusion and
      exclusion criteria; obtain history Perform Flexible Nasolaryngoscopy by otolaryngology
      resident, document by videorecording

      Vocal Cord Mobility Assessment 2 Post operative day 1-2 Perform Flexible Nasolaryngoscopy by
      otolaryngology resident, document by videorecording

      Collection of functional outcomes Hospital Discharge or Death Collection of data on
      respiratory, voice, swallowing, cardiovascular mortality outcomes, hospital length of stay
      and ICU admission duration

      Review of Vocal Cord Mobility Assessment by expert (Laryngologist) by review of
      videorecordings of nasolaryngoscopy

      Statistical Analysis Final Assessments Association of vocal cord immobility and functional
      outcomes and death.

      2.1 Background Information Research Question: In patients undergoing thoracic surgery, what
      is the incidence of respiratory and associated complications in the 30 day post-operative
      period among those with/without Recurrent Laryngeal Nerve (RLN) Injury?

      Background: The issue of RLN injury is an important clinical challenge in thoracic surgery,
      as respiratory complications are the greatest source of morbidity in our surgical population
      . Clinical care experience and the literature demonstrate a high incidence of respiratory
      complications (20-60% incidence of pneumonia for esophagectomy and a 20% death rate for those
      who contract pneumonia) in the post-operative thoracic surgery population.

      The thoracic surgery population is at uniquely elevated risk for respiratory complications
      due to the high prevalence of COPD, the nature of the primary surgical procedure directly
      diminishing pulmonary function and toilet; and possible RLN injury. The only modifiable
      element of this triad is RLN injury, and appears to be the most important element based on
      clinical experience and the limited literature available. The RLN supplies motor innervation
      to the vocal cords; vocal cord closure is considered the most important protective mechanism
      against aspiration into the lungs . Patients with a RLN injury demonstrate a 5-fold risk of
      contracting pneumonia, a 5-fold risk of reintubation or tracheostomy , and have 40-60% longer
      hospital stays than patients without RLN injury.

      The current literature base is substantially lacking with regards to the incidence of RLN
      injury, with estimates varying from 4-80% based on retrospective reviews or prospective
      studies which fail to examine all patients. The highest quality studies demonstrate a RLN
      injury rate in the range of 20-40% for major procedures such as esophagectomy and
      pneumonectomy.

      With the recent advent of injection laryngoplasty for vocal cord medialization, there is now
      a practical means of potentially altering the course of this pathologic triad. This procedure
      can be performed at the bedside under local anesthetic, allowing for early intervention in
      this high-risk population as a bulwark against aspiration.

      Prospectively examining the incidence of pre and post-operative vocal cord immobility in all
      thoracic surgery patients is the only means to quantify the health burden associated with RLN
      injury.

      Potential Risks Potential risks of the study include time involved in considering
      participation, providing consent and data such as subjective voice quality and undergoing
      flexible nasolaryngoscopy to assess vocal cord status. No health, economic or legal risks are
      anticipated for the participants.

      Potential Benefits No direct benefit, either monetary or health improvement will accrue to
      patients from participation in the study.

      Study Outcome Measures Vocal Cord Mobility - Flexible nasolaryngoscopy to visualize mobility
      status of vocal cords.

      Voice - Voice Handicap Index 10. Validated instrument used for subjective assessment of
      voice, 10 plain language questions answered by the patient.

      Respiratory: Incidence of pneumonia (as defined by CDC criteria) and intubation Swallowing:
      Oral diet vs NPO and diet texture tolerated at discharge Cardiovascular: Myocardial
      Infarction as defined by the third universal criteria 2012 by third ESC/ACCF/AHA/WHF,
      Cerebrovascular Accident as defined by WHO MONICA criteria and Neurology specialist
      consultation
observational model: Cohort
time perspective: Prospective
measure: Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy on the first post-operative day
time frame: Post-operative day 1
measure: Number of patients with respiratory complictions
time frame: Within 30 days of operation
measure: Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy prior to operation
time frame: Day of operation
measure: Hospital length of stay
time frame: From date of primary operation to discharge
description: Number of days between admission to hospital and discharge
measure: The number of patients with swallowing difficulties, cardiac complications and who have died
time frame: From the date of operation to day 30 after operation
measure: ICU length of stay
time frame: From date of operation to discharge from hospital
description: The total number of days admitted to the intensive care unit (a facility where full ventilator support and inotropic support can be provided) If more than one admission episode to the ICU, the total number of days in the ICU census is counted across the multiple admission episodes.
measure: Readmission to hospital
time frame: From day of surgery to day 90 after operation
description: Number of readmission episodes after initial discharge and during the 90 day period after surgery
arm group label: Intact Vocal Cord Mobility
description: Patients with normal laryngeal function post thoracic surgery
arm group label: Vocal Cord Dysfunction
description: Patients with abnormal vocal cord movement of 1 or both vocal cords post thoracic surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sadeesh Srinathan, MD
role: Principal Investigator
affiliation: University of Manitoba
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Sadeesh Srinathan, MD
investigator title: Dr. Sadeesh Srinathan Associate Professor Section of Thoracic Surgery
mesh term: Vocal Cord Dysfunction
mesh term: Vocal Cord Paralysis
mesh term: Paresis
sharing ipd: Undecided