<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/NCT03250975</url>
  </required_header>
  <id_info>
    <org_study_id>171066</org_study_id>
    <nct_id>NCT03250975</nct_id>
  </id_info>
  <brief_title>Incidence of Acute Laryngeal Injury Following Endotracheal Intubation</brief_title>
  <official_title>Incidence of Acute Laryngeal Injury Following Endotracheal Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this investigation is to delineate the incidence of acute and chronic&#xD;
      laryngeal injury following intubation within our health system. In addition, this study seeks&#xD;
      to identify risk factors for airway injury that may provide information to help reduce the&#xD;
      incidence of injury or increase the speed of diagnosis through hospital based process&#xD;
      measures.&#xD;
&#xD;
      Study Aims&#xD;
&#xD;
        1. Determine the incidence of acute laryngeal injury in patients with prolonged intubation.&#xD;
&#xD;
        2. Determine the incidence of chronic laryngeal injury in the subset of patients with acute&#xD;
           laryngeal injury&#xD;
&#xD;
        3. Initiate a randomized control trial to investigate the ability of azithromycin and&#xD;
           budesonide to improve objective and subjective breathing measures in patients with Acute&#xD;
           Laryngeal injury (ALgI) following endotracheal intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the United States, 55 000 patients receive care in more than 6 000 intensive care units&#xD;
      (ICUs) each day. The most common reason for ICU admission is respiratory failure and the need&#xD;
      for a mechanical ventilator. Although 50% to 70% of patients survive their acute illness, the&#xD;
      remainder are left with massive impairments in health and overall functioning. One of the&#xD;
      most severe post-ICU complications is airway scaring directly resulting from endotracheal&#xD;
      intubation.&#xD;
&#xD;
      Scarring of the vocal cords or trachea after intubation results from mucosal injury by an&#xD;
      endotracheal tube (i.e. breathing tube). The initial mucosal injury ultimately heals with&#xD;
      pathologic fibrotic contracture. This fibrosis physiologically restricts ventilation, and&#xD;
      produces life-threatening dyspnea and airway obstruction. Acute and chronic airway injury&#xD;
      following intubation is largely unappreciated owing to the fact that the long-term sequelae&#xD;
      of intensive respiratory support is rarely managed by practitioners providing acute care.&#xD;
      Treatments for chronic airway injury are suboptimal. They are largely surgical and offer&#xD;
      marginal improvement in breathing while causing permanently worsened voice. Preventative&#xD;
      efforts to preserve laryngeal and tracheal function (through identification of modifiable&#xD;
      risk factors) could reduce the incidence of this devastating complication of medical care.&#xD;
      Additionally, early identification of acute laryngeal injury after intubation may prevent the&#xD;
      development of chronic complications. Patients with acute post-intubation airway injury&#xD;
      treated with early endoscopic surgery require significantly fewer procedures, and may avoid&#xD;
      an invasive open surgical reconstruction compared with patients treated with chronic fibrotic&#xD;
      scars.&#xD;
&#xD;
      The development of airway fibrosis and ventilatory obstruction has been linked to&#xD;
      inflammatory processes. Macrolide antibiotics such as azithromycin has been shown to reduce&#xD;
      mucosal airway inflammation. IN addition the combination of a macrolide antibiotic and&#xD;
      budesonide an inhaled corticosteroid has been shown to work synergistically to reduce&#xD;
      inflammation and modify the disease process of tracheal stenosis in rabbit models.&#xD;
&#xD;
      The purpose of this investigation is to delineate the incidence of acute and chronic&#xD;
      laryngeal injury following intubation within our health system. In addition, this study seeks&#xD;
      to identify risk factors for airway injury that may provide information to help reduce the&#xD;
      incidence of injury or increase the speed of diagnosis through hospital based process&#xD;
      measures. Finally, in patients with acute laryngeal injury, this study seeks to investigate&#xD;
      the effects of azithromycin and budesonide to improve objective and subjective breathing&#xD;
      measures in patients with Acute Laryngeal injury (ALgI) following endotracheal intubation.&#xD;
&#xD;
      Overview: Patients will be recruited from adult patients in the surgical and medical&#xD;
      intensive care units of Vanderbilt Medical Center who were intubated for greater than 48&#xD;
      hours. Following informed consent and study enrolment, data will be stored in a secure REDCap&#xD;
      database housed within a server located behind the Vanderbilt University Medical Center&#xD;
      (VUMC) firewall. Data analysis will be performed by KSP at VUMC.&#xD;
&#xD;
      Protocol: Within 72 hours of extubation, ICU patients will be approached for participation by&#xD;
      study KSP (they will be clinically evaluated for the ability to provide informed consent). If&#xD;
      they are not able to consent for themselves an LAR will be approached for consent by study&#xD;
      KSP. Consent will be electronic, paper, or via phone.&#xD;
&#xD;
      Consented and enrolled patients will undergo routine medical examination of their larynx with&#xD;
      flexible nasolaryngoscopy after anesthetizing and decongesting the nose with 1% lidocaine&#xD;
      mixed in oxymetazoline. During the examination, patients will be asked to sniff (which&#xD;
      triggers opening of the vocal cords), and say &quot;Eee&quot; which (triggers closing). These maneuvers&#xD;
      allow assessment of vocal fold movement. The evaluation will be recorded for subsequent&#xD;
      blinded review. Recordings will be coded with a research identifier and stored digitally&#xD;
      securely on a harddisk locked within the principle investigators office. If acute laryngeal&#xD;
      injury is noted on examination, a repeat office-based examination of the larynx will be&#xD;
      scheduled in 8 to 12 weeks.&#xD;
&#xD;
      The second phase of this study will investigate the effects of azithromycin and budesonide to&#xD;
      improve objective and subjective breathing measures in patients with Acute Laryngeal injury&#xD;
      (ALgI) following endotracheal intubation. The consenting process for these patients will&#xD;
      mirror the first phase. In patients with ALgI, patients will be randomized to a medical&#xD;
      therapy group consisting azithromycin 250mg or budesonide of 0.5mg for 14 days or non-drug&#xD;
      placebo group. This study will be double blinded. For participants, a repeat examination will&#xD;
      be scheduled at 12 weeks and at that time patients will be asked to complete surveys (CCQ,&#xD;
      VHI-10, SF-12).&#xD;
&#xD;
      Consented patients will also have information abstracted from their medical record. Pertinent&#xD;
      information collected will include patient-specific covariates; i.e. medical co-morbidities,&#xD;
      laboratory values, and demographics as well as procedure-specific covariates; i.e.&#xD;
      endotracheal tube size, length of intubation, recorded endotracheal tube cuff pressures, and&#xD;
      the number of recorded intubation attempts. The initial and follow up examinations will be&#xD;
      non-billable and provided no-cost to the patients. If chronic laryngeal injury is noted on&#xD;
      follow-up examination, the patients will then be referred within the institution as a routine&#xD;
      patient and offered standard treatment options as directed by a fellowship trained&#xD;
      laryngologist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 19, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute Laryngeal Injury</measure>
    <time_frame>Within 72 hours of extubation</time_frame>
    <description>Endoscopic examination with evidence of laryngeal injury</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chronic Obstructive Pulmonary Disease Dyspnea Questionnaire (CCQ)</measure>
    <time_frame>12 week follow up</time_frame>
    <description>12 week patient-reported dyspnea via CCQ. Total score is recorded, with a range of 0-60 with higher values representing worse outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chronic Laryngeal Injury</measure>
    <time_frame>8-12 weeks after sustaining acute laryngeal injury</time_frame>
    <description>In those with acute laryngeal injury, what is the incidence of chronic laryngeal injury</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Intubation Complication</condition>
  <arm_group>
    <arm_group_label>Medical Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo control medication for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonide and Azithromycin</intervention_name>
    <description>Participant with acute laryngeal injury will be randomized at discharge to either a non-drug placebo control group or a medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days.</description>
    <arm_group_label>Medical Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo control of budesonide and azithromycin</intervention_name>
    <description>placebos of the medications will be given for 14 days in patients randomized to the control group</description>
    <arm_group_label>Placebo Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. English-speaking&#xD;
&#xD;
          2. Greater than 24 hours and less than 7 days of intubation in the intensive care unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age under 18 years on admission&#xD;
&#xD;
          2. Patients with anticipated discharge 5 days after extubation&#xD;
&#xD;
          3. Patients who are dependent for activities of daily living (ADLs) in the 30 days prior&#xD;
             to admission&#xD;
&#xD;
          4. Patients unable to consent&#xD;
&#xD;
          5. Patients with neck trauma&#xD;
&#xD;
          6. Patients with head and neck malignancies&#xD;
&#xD;
          7. Patients with pre-existing laryngeal or tracheal stenosis&#xD;
&#xD;
          8. Patients with other pre-existing respiratory conditions such as chronic obstructive&#xD;
             pulmonary disease (COPD), asthma, neuromuscular dystrophies, cystic fibrosis,&#xD;
             bronchiectasis&#xD;
&#xD;
          9. Patients who had been previously intubated for an extended period of time&#xD;
&#xD;
         10. Patients who are pregnant or currently breastfeeding&#xD;
&#xD;
         11. Patients with allergies to study medications&#xD;
&#xD;
         12. Patients with a resting heart rate greater than 100 beats per minute&#xD;
&#xD;
         13. Patients with a prolonged corrected QT (QTc) interval (&gt;450 msec) or the use of&#xD;
             medications that prolong the QTc interval or are associated with Torsades de pointes&#xD;
             (with the exception of amiodarone)24&#xD;
&#xD;
         14. Patients with severe hearing impairment documented by audiometric testing&#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>Alexander Gelbard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Justin R Shinn, MD</last_name>
    <phone>(406)531-9698</phone>
    <email>justin.r.shinn@vanderbilt.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anne S Lowery, BA</last_name>
    <phone>314-373-9228</phone>
    <email>anne.sun@vanderbilt.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kate Von Wahlde, MJ, CCRP</last_name>
      <phone>615-322-0333</phone>
      <email>kate.vonwahlde@vanderbilt.edu</email>
    </contact>
    <investigator>
      <last_name>Alexander Gelbard, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Justin Shinn, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.</citation>
    <PMID>11445675</PMID>
  </reference>
  <reference>
    <citation>Hillel AT, Karatayli-Ozgursoy S, Samad I, Best SR, Pandian V, Giraldez L, Gross J, Wootten C, Gelbard A, Akst LM, Johns MM; North American Airway Collaborative (NoAAC). Predictors of Posterior Glottic Stenosis: A Multi-Institutional Case-Control Study. Ann Otol Rhinol Laryngol. 2016 Mar;125(3):257-63. doi: 10.1177/0003489415608867. Epub 2015 Oct 14.</citation>
    <PMID>26466860</PMID>
  </reference>
  <reference>
    <citation>Gelbard A, Francis DO, Sandulache VC, Simmons JC, Donovan DT, Ongkasuwan J. Causes and consequences of adult laryngotracheal stenosis. Laryngoscope. 2015 May;125(5):1137-43. doi: 10.1002/lary.24956. Epub 2014 Oct 7.</citation>
    <PMID>25290987</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 20, 2023</last_update_submitted>
  <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Alexander Gelbard, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Intubation injury</keyword>
  <keyword>Acute laryngeal injury</keyword>
  <keyword>Chronic Laryngeal Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Budesonide</mesh_term>
  </intervention_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/NCT03250975
org study id: 171066
nct id: NCT03250975
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this investigation is to delineate the incidence of acute and chronic
      laryngeal injury following intubation within our health system. In addition, this study seeks
      to identify risk factors for airway injury that may provide information to help reduce the
      incidence of injury or increase the speed of diagnosis through hospital based process
      measures.

      Study Aims

        1. Determine the incidence of acute laryngeal injury in patients with prolonged intubation.

        2. Determine the incidence of chronic laryngeal injury in the subset of patients with acute
           laryngeal injury

        3. Initiate a randomized control trial to investigate the ability of azithromycin and
           budesonide to improve objective and subjective breathing measures in patients with Acute
           Laryngeal injury (ALgI) following endotracheal intubation.
In the United States, 55 000 patients receive care in more than 6 000 intensive care units
      (ICUs) each day. The most common reason for ICU admission is respiratory failure and the need
      for a mechanical ventilator. Although 50% to 70% of patients survive their acute illness, the
      remainder are left with massive impairments in health and overall functioning. One of the
      most severe post-ICU complications is airway scaring directly resulting from endotracheal
      intubation.

      Scarring of the vocal cords or trachea after intubation results from mucosal injury by an
      endotracheal tube (i.e. breathing tube). The initial mucosal injury ultimately heals with
      pathologic fibrotic contracture. This fibrosis physiologically restricts ventilation, and
      produces life-threatening dyspnea and airway obstruction. Acute and chronic airway injury
      following intubation is largely unappreciated owing to the fact that the long-term sequelae
      of intensive respiratory support is rarely managed by practitioners providing acute care.
      Treatments for chronic airway injury are suboptimal. They are largely surgical and offer
      marginal improvement in breathing while causing permanently worsened voice. Preventative
      efforts to preserve laryngeal and tracheal function (through identification of modifiable
      risk factors) could reduce the incidence of this devastating complication of medical care.
      Additionally, early identification of acute laryngeal injury after intubation may prevent the
      development of chronic complications. Patients with acute post-intubation airway injury
      treated with early endoscopic surgery require significantly fewer procedures, and may avoid
      an invasive open surgical reconstruction compared with patients treated with chronic fibrotic
      scars.

      The development of airway fibrosis and ventilatory obstruction has been linked to
      inflammatory processes. Macrolide antibiotics such as azithromycin has been shown to reduce
      mucosal airway inflammation. IN addition the combination of a macrolide antibiotic and
      budesonide an inhaled corticosteroid has been shown to work synergistically to reduce
      inflammation and modify the disease process of tracheal stenosis in rabbit models.

      The purpose of this investigation is to delineate the incidence of acute and chronic
      laryngeal injury following intubation within our health system. In addition, this study seeks
      to identify risk factors for airway injury that may provide information to help reduce the
      incidence of injury or increase the speed of diagnosis through hospital based process
      measures. Finally, in patients with acute laryngeal injury, this study seeks to investigate
      the effects of azithromycin and budesonide to improve objective and subjective breathing
      measures in patients with Acute Laryngeal injury (ALgI) following endotracheal intubation.

      Overview: Patients will be recruited from adult patients in the surgical and medical
      intensive care units of Vanderbilt Medical Center who were intubated for greater than 48
      hours. Following informed consent and study enrolment, data will be stored in a secure REDCap
      database housed within a server located behind the Vanderbilt University Medical Center
      (VUMC) firewall. Data analysis will be performed by KSP at VUMC.

      Protocol: Within 72 hours of extubation, ICU patients will be approached for participation by
      study KSP (they will be clinically evaluated for the ability to provide informed consent). If
      they are not able to consent for themselves an LAR will be approached for consent by study
      KSP. Consent will be electronic, paper, or via phone.

      Consented and enrolled patients will undergo routine medical examination of their larynx with
      flexible nasolaryngoscopy after anesthetizing and decongesting the nose with 1% lidocaine
      mixed in oxymetazoline. During the examination, patients will be asked to sniff (which
      triggers opening of the vocal cords), and say "Eee" which (triggers closing). These maneuvers
      allow assessment of vocal fold movement. The evaluation will be recorded for subsequent
      blinded review. Recordings will be coded with a research identifier and stored digitally
      securely on a harddisk locked within the principle investigators office. If acute laryngeal
      injury is noted on examination, a repeat office-based examination of the larynx will be
      scheduled in 8 to 12 weeks.

      The second phase of this study will investigate the effects of azithromycin and budesonide to
      improve objective and subjective breathing measures in patients with Acute Laryngeal injury
      (ALgI) following endotracheal intubation. The consenting process for these patients will
      mirror the first phase. In patients with ALgI, patients will be randomized to a medical
      therapy group consisting azithromycin 250mg or budesonide of 0.5mg for 14 days or non-drug
      placebo group. This study will be double blinded. For participants, a repeat examination will
      be scheduled at 12 weeks and at that time patients will be asked to complete surveys (CCQ,
      VHI-10, SF-12).

      Consented patients will also have information abstracted from their medical record. Pertinent
      information collected will include patient-specific covariates; i.e. medical co-morbidities,
      laboratory values, and demographics as well as procedure-specific covariates; i.e.
      endotracheal tube size, length of intubation, recorded endotracheal tube cuff pressures, and
      the number of recorded intubation attempts. The initial and follow up examinations will be
      non-billable and provided no-cost to the patients. If chronic laryngeal injury is noted on
      follow-up examination, the patients will then be referred within the institution as a routine
      patient and offered standard treatment options as directed by a fellowship trained
      laryngologist.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: Acute Laryngeal Injury
time frame: Within 72 hours of extubation
description: Endoscopic examination with evidence of laryngeal injury
measure: Chronic Obstructive Pulmonary Disease Dyspnea Questionnaire (CCQ)
time frame: 12 week follow up
description: 12 week patient-reported dyspnea via CCQ. Total score is recorded, with a range of 0-60 with higher values representing worse outcomes.
measure: Chronic Laryngeal Injury
time frame: 8-12 weeks after sustaining acute laryngeal injury
description: In those with acute laryngeal injury, what is the incidence of chronic laryngeal injury
arm group label: Medical Therapy
arm group type: Experimental
description: medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days
arm group label: Placebo Control
arm group type: Placebo Comparator
description: Placebo control medication for 14 days
intervention type: Drug
intervention name: Budesonide and Azithromycin
description: Participant with acute laryngeal injury will be randomized at discharge to either a non-drug placebo control group or a medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days.
arm group label: Medical Therapy
intervention type: Other
intervention name: Placebo control of budesonide and azithromycin
description: placebos of the medications will be given for 14 days in patients randomized to the control group
arm group label: Placebo Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Gelbard, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Justin R Shinn, MD
phone: (406)531-9698
email: justin.r.shinn@vanderbilt.edu
last name: Anne S Lowery, BA
phone: 314-373-9228
email: anne.sun@vanderbilt.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
citation: Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
PMID: 11445675
citation: Hillel AT, Karatayli-Ozgursoy S, Samad I, Best SR, Pandian V, Giraldez L, Gross J, Wootten C, Gelbard A, Akst LM, Johns MM; North American Airway Collaborative (NoAAC). Predictors of Posterior Glottic Stenosis: A Multi-Institutional Case-Control Study. Ann Otol Rhinol Laryngol. 2016 Mar;125(3):257-63. doi: 10.1177/0003489415608867. Epub 2015 Oct 14.
PMID: 26466860
citation: Gelbard A, Francis DO, Sandulache VC, Simmons JC, Donovan DT, Ongkasuwan J. Causes and consequences of adult laryngotracheal stenosis. Laryngoscope. 2015 May;125(5):1137-43. doi: 10.1002/lary.24956. Epub 2014 Oct 7.
PMID: 25290987
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Alexander Gelbard, MD
investigator title: Assistant Professor
mesh term: Wounds and Injuries
mesh term: Azithromycin
mesh term: Budesonide
sharing ipd: Undecided