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/NCT06033144</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00040-45</org_study_id>
      <nct_id>NCT06033144</nct_id>
    </id_info>
    <brief_title>Prevalence of Tapia's Syndrome in Weaning Unit</brief_title>
    <acronym>PRESTIO</acronym>
    <official_title>Prevalence of Tapia's Syndrome in Weaning Unit and Associated Factors After Orotracheal Intubation in the ICU</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hopital Forcilles</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hopital Forcilles</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Tapia syndrome is a rare and poorly understood pathology. It is defined by a concomitant&#xD;
        attack of the recurrent (branch of X) and hypoglossal (XII) nerves of peripheral or central&#xD;
        origin. It is characterized by the paralysis of a vocal cord and the ipsilateral half of&#xD;
        tongue. This damage is most often unilateral but it can also be bilateral. It results in&#xD;
        dysphonia and swallowing disorders.&#xD;
  &#xD;
        Tapia syndrome is a rare and poorly understood pathology. To date, less than 100 cases have&#xD;
        been described in the literature. Previous works are mainly case reports and literature&#xD;
        reviews. No prevalence study has been performed to date. Furthermore, disagreements persist&#xD;
        regarding the semiology. Indeed, the involvement of the soft palate is not always described.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main aim of this study was to determine the prevalence of Tapia syndrome in patients&#xD;
        admitted to weaning unit after prolonged (&gt;48h) orotracheal intubation in the ICU.&#xD;
  &#xD;
        The secondary objectives are to:&#xD;
  &#xD;
          -  Describe the clinical semiology of Tapia syndrome : lingual involvement, soft palate&#xD;
             involvement, impairment of phonation and swallowing ;&#xD;
  &#xD;
          -  Describe the paraclinical features of Tapia syndrome: recurrent involvement, laryngeal&#xD;
             and lingual involvement;&#xD;
  &#xD;
          -  Identify factors associated with Tapia's syndrome&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">April 7, 2023</start_date>
    <completion_date type="Anticipated">April 7, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 7, 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Prevalence of Tapia's syndrome</measure>
      <time_frame>through study completion, an average of 2 years</time_frame>
      <description>The main objective of this study is to determine the prevalence of Tapia syndrome in patients admitted to the weaning unit after prolonged orotracheal intubation in intensive care. The orotracheal intubation is defined as an intubation longer than 48 hours.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Lingual involvment</measure>
      <time_frame>through study completion, an average of 2 years</time_frame>
      <description>yes/no/measure of lingual deviation in mm and width of each half of tongue in mm with MEEI software)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soft palate involvement</measure>
      <time_frame>through study completion, an average of 2 years</time_frame>
      <description>yes/no</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determining the factors associated with Tapia syndrome</measure>
      <time_frame>The day of inclusion</time_frame>
      <description>Determining the factors associated with Tapia syndrome : number of prone sessions, duration of intubation (day), duration of mechanical ventilation (day), tracheostomy duration (day), Cormack-Lehane's class, time to tracheostomy cannula removal (day), the time to resume oral feeding (day), number of days in the ICU, number of days in weaning unit, the number of pulmonary infections during the intubation and tracheostomy period, sex, the size of the intubation probe in mm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dysphonia</measure>
      <time_frame>After initial swallowing test, maximum 1 week</time_frame>
      <description>GRBAS, maximum time of phonation (s), base frequency (Hz), jitter (%), harmonic noise ratio (dB), vocal range (dB), vocal tessitura (dB)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dysphagia</measure>
      <time_frame>through study completion, an average of 2 years</time_frame>
      <description>Functional oral intake scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nasofibroscopy</measure>
      <time_frame>After initial swallowing test, maximum 1 week</time_frame>
      <description>immobility of one or both vocal cords on nasofibroscopy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ultrasound</measure>
      <time_frame>After initial swallowing test, maximum 1 week</time_frame>
      <description>hyoid-mandibular distance at rest and during swallowing in cm), tongue thickness at rest in cm, geniohyoidien thickness in mm and area in mm2, echogenicity (Heckmatt score), vallecula stasis (yes/no), stasis in the piriform sinuses (yes/no)</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">247</enrollment>
    <condition>Tapia's Syndrome</condition>
    <arm_group>
      <arm_group_label>&quot;Non Tapia group&quot;</arm_group_label>
      <description>Patients without Tapia's syndrome</description>
    </arm_group>
    <arm_group>
      <arm_group_label>&quot;Tapia group&quot;</arm_group_label>
      <description>Patient with Tapia's syndrome</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Diagnosis of Tapia's Syndrome</intervention_name>
      <description>The diagnostic includes :&#xD;
  Lingual clinical examination&#xD;
  Nasofibroscopy&#xD;
  Ultrasonography</description>
      <arm_group_label>&quot;Non Tapia group&quot;</arm_group_label>
      <arm_group_label>&quot;Tapia group&quot;</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who were intubated during more than 48 hours in ICU then tracheostomized and&#xD;
          hospitalized in weaning unit.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hospitalized in weaning unit&#xD;
  &#xD;
            -  Duration of orotracheal intubation in the ICU greater than 48 hours;&#xD;
  &#xD;
            -  Glasgow score greater than or equal to 13 ;&#xD;
  &#xD;
            -  Patient at least 18 years of age at the time of inclusion;&#xD;
  &#xD;
            -  Affiliation with a social security system or beneficiary of such a system ;&#xD;
  &#xD;
            -  Oral, free, informed and express consent of the patient.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known history of ENT or neurological pathologies (stroke, head trauma,&#xD;
               neurodegenerative disease, brain tumor, ENT cancer);&#xD;
  &#xD;
            -  Known tumors in the vicinity of the X-nerve pathway;&#xD;
  &#xD;
            -  Ortner's syndrome (left recurrent nerve compression through the left atrium in mitral&#xD;
               stenosis);&#xD;
  &#xD;
            -  Left lung cancer with subaortic lesion;&#xD;
  &#xD;
            -  History of cervical adenopathy compressing the X nerve;&#xD;
  &#xD;
            -  Presence of a cervical or cerebral abscess;&#xD;
  &#xD;
            -  24-hour ventilated patient;&#xD;
  &#xD;
            -  Refusal of the patient or designated trusted person to participate in the study;&#xD;
  &#xD;
            -  Person subject to a safeguard of justice measure ;&#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>Hôpital Forcilles</name>
        <address>
          <city>Férolles-Attilly</city>
          <state>Seine-et-Marne</state>
          <zip>77150</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <reference>
      <citation>Lykoudis EG, Seretis K. Tapia's syndrome: an unexpected but real complication of rhinoplasty: case report and literature review. Aesthetic Plast Surg. 2012 Jun;36(3):557-9. doi: 10.1007/s00266-011-9849-y. Epub 2011 Dec 17.</citation>
      <PMID>22179851</PMID>
    </reference>
    <reference>
      <citation>De Luca P, Cavaliere M, Scarpa A, Savignano L, Cassandro E, Cassandro C, Iemma M. Rehabilitation Protocol for Unilateral Laryngeal and Lingual Paralysis (Tapia Syndrome): Comment About &quot;A Challenging Case of Tapia Syndrome After Total Thyroidectomy&quot; By Ildem Deveci, Mehmet Surmeli, and Reyhan Surmeli. Ear Nose Throat J. 2021 Sep;100(5_suppl):734S-737S. doi: 10.1177/0145561320907433. Epub 2020 Feb 23.</citation>
      <PMID>32088986</PMID>
    </reference>
    <reference>
      <citation>Boga I, Aktas S. Treatment, classification, and review of Tapia syndrome. J Craniofac Surg. 2010 Jan;21(1):278-80. doi: 10.1097/SCS.0b013e3181c678f0.</citation>
      <PMID>20098201</PMID>
    </reference>
    <reference>
      <citation>Caranti A, Bianchini C, Corazzi V, Pelucchi S, Ciorba A. Tapia's Syndrome: keep it in mind! Minerva Anestesiol. 2022 Apr;88(4):293-299. doi: 10.23736/S0375-9393.21.16037-7.</citation>
      <PMID>35410105</PMID>
    </reference>
    <reference>
      <citation>Decavel P, Petit C, Tatu L. Tapia syndrome at the time of the COVID-19 pandemic: Lower cranial neuropathy following prolonged intubation. Neurology. 2020 Aug 18;95(7):312-313. doi: 10.1212/WNL.0000000000010011. Epub 2020 Jun 9. No abstract available.</citation>
      <PMID>32518147</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <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/NCT06033144
  org study id: 2023-A00040-45
  nct id: NCT06033144
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Tapia syndrome is a rare and poorly understood pathology. It is defined by a concomitant
        attack of the recurrent (branch of X) and hypoglossal (XII) nerves of peripheral or central
        origin. It is characterized by the paralysis of a vocal cord and the ipsilateral half of
        tongue. This damage is most often unilateral but it can also be bilateral. It results in
        dysphonia and swallowing disorders.
  
        Tapia syndrome is a rare and poorly understood pathology. To date, less than 100 cases have
        been described in the literature. Previous works are mainly case reports and literature
        reviews. No prevalence study has been performed to date. Furthermore, disagreements persist
        regarding the semiology. Indeed, the involvement of the soft palate is not always described.
  The main aim of this study was to determine the prevalence of Tapia syndrome in patients
        admitted to weaning unit after prolonged (>48h) orotracheal intubation in the ICU.
  
        The secondary objectives are to:
  
          -  Describe the clinical semiology of Tapia syndrome : lingual involvement, soft palate
             involvement, impairment of phonation and swallowing ;
  
          -  Describe the paraclinical features of Tapia syndrome: recurrent involvement, laryngeal
             and lingual involvement;
  
          -  Identify factors associated with Tapia's syndrome
  observational model: Cohort
  time perspective: Prospective
  measure: Prevalence of Tapia's syndrome
  time frame: through study completion, an average of 2 years
  description: The main objective of this study is to determine the prevalence of Tapia syndrome in patients admitted to the weaning unit after prolonged orotracheal intubation in intensive care. The orotracheal intubation is defined as an intubation longer than 48 hours.
  measure: Lingual involvment
  time frame: through study completion, an average of 2 years
  description: yes/no/measure of lingual deviation in mm and width of each half of tongue in mm with MEEI software)
  measure: Soft palate involvement
  time frame: through study completion, an average of 2 years
  description: yes/no
  measure: Determining the factors associated with Tapia syndrome
  time frame: The day of inclusion
  description: Determining the factors associated with Tapia syndrome : number of prone sessions, duration of intubation (day), duration of mechanical ventilation (day), tracheostomy duration (day), Cormack-Lehane's class, time to tracheostomy cannula removal (day), the time to resume oral feeding (day), number of days in the ICU, number of days in weaning unit, the number of pulmonary infections during the intubation and tracheostomy period, sex, the size of the intubation probe in mm
  measure: Dysphonia
  time frame: After initial swallowing test, maximum 1 week
  description: GRBAS, maximum time of phonation (s), base frequency (Hz), jitter (%), harmonic noise ratio (dB), vocal range (dB), vocal tessitura (dB)
  measure: Dysphagia
  time frame: through study completion, an average of 2 years
  description: Functional oral intake scale
  measure: Nasofibroscopy
  time frame: After initial swallowing test, maximum 1 week
  description: immobility of one or both vocal cords on nasofibroscopy
  measure: Ultrasound
  time frame: After initial swallowing test, maximum 1 week
  description: hyoid-mandibular distance at rest and during swallowing in cm), tongue thickness at rest in cm, geniohyoidien thickness in mm and area in mm2, echogenicity (Heckmatt score), vallecula stasis (yes/no), stasis in the piriform sinuses (yes/no)
  arm group label: "Non Tapia group"
  description: Patients without Tapia's syndrome
  arm group label: "Tapia group"
  description: Patient with Tapia's syndrome
  intervention type: Diagnostic Test
  intervention name: Diagnosis of Tapia's Syndrome
  description: The diagnostic includes :
  Lingual clinical examination
  Nasofibroscopy
  Ultrasonography
  arm group label: "Non Tapia group"
  arm group label: "Tapia group"
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: France
  citation: Lykoudis EG, Seretis K. Tapia's syndrome: an unexpected but real complication of rhinoplasty: case report and literature review. Aesthetic Plast Surg. 2012 Jun;36(3):557-9. doi: 10.1007/s00266-011-9849-y. Epub 2011 Dec 17.
  PMID: 22179851
  citation: De Luca P, Cavaliere M, Scarpa A, Savignano L, Cassandro E, Cassandro C, Iemma M. Rehabilitation Protocol for Unilateral Laryngeal and Lingual Paralysis (Tapia Syndrome): Comment About "A Challenging Case of Tapia Syndrome After Total Thyroidectomy" By Ildem Deveci, Mehmet Surmeli, and Reyhan Surmeli. Ear Nose Throat J. 2021 Sep;100(5_suppl):734S-737S. doi: 10.1177/0145561320907433. Epub 2020 Feb 23.
  PMID: 32088986
  citation: Boga I, Aktas S. Treatment, classification, and review of Tapia syndrome. J Craniofac Surg. 2010 Jan;21(1):278-80. doi: 10.1097/SCS.0b013e3181c678f0.
  PMID: 20098201
  citation: Caranti A, Bianchini C, Corazzi V, Pelucchi S, Ciorba A. Tapia's Syndrome: keep it in mind! Minerva Anestesiol. 2022 Apr;88(4):293-299. doi: 10.23736/S0375-9393.21.16037-7.
  PMID: 35410105
  citation: Decavel P, Petit C, Tatu L. Tapia syndrome at the time of the COVID-19 pandemic: Lower cranial neuropathy following prolonged intubation. Neurology. 2020 Aug 18;95(7):312-313. doi: 10.1212/WNL.0000000000010011. Epub 2020 Jun 9. No abstract available.
  PMID: 32518147
  responsible party type: Sponsor
  mesh term: Syndrome
  sharing ipd: No