<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/NCT04422964</url>
  </required_header>
  <id_info>
    <org_study_id>3D Obturator Pilot</org_study_id>
    <nct_id>NCT04422964</nct_id>
  </id_info>
  <brief_title>Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect (3D Obturator) - Pilot Trial</brief_title>
  <acronym>Pilobtur</acronym>
  <official_title>Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect: Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brno University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brno University of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Masaryk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brno University Hospital</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>
      Congenital malformations of the orofacial area are the most common congenital malformations&#xD;
      in children with an incidence of 1.8 children with orofacial cleft per 1000 healthy births in&#xD;
      the Czech Republic. The care of children with cleft facial defects is multidisciplinary,&#xD;
      centralized and takes place from birth to adulthood. At the University Hospital Brno, the&#xD;
      treatment for patients with orofacial cleft is provided by the Cleft Center (CC) of the&#xD;
      University Hospital Brno. The main specialties that form the basis of CC include plastic&#xD;
      surgery, pediatric anesthesiology and neonatology. Patients with facial cleft defects are&#xD;
      divided into 2 main groups based on the embryological causes of clefts: 1/ patients with&#xD;
      cleft lip, jaw with or without cleft palate (total cleft) and 2/ patients with isolated cleft&#xD;
      soft and hard palate. Anesthesia in children with orofacial clefts is specific not only to&#xD;
      the age of the patients, but mainly to the cleft itself. Anesthesiology management, and&#xD;
      especially intubation of these patients, are often difficult due to the nature of the defect&#xD;
      with high incidence of complications such as difficult airway, desaturation, laryngospasm or&#xD;
      bradycardia. In addition, tissue damage including soft tissue of the lip, alveolar arch,&#xD;
      palate and nasal septum as well as skeleton of the premaxilla and nasal septum during&#xD;
      intubation is seen in approximately 90% of patients. To facilitate intubation, improve&#xD;
      anesthesiology management and safety of pediatric patients with orofacial cleft,&#xD;
      investigators will develop an individualized protective tray from a silicone material, that&#xD;
      will be used during intubation to cover the defect of the alveolar arch and palate. A mold&#xD;
      for casting of a protective tray, will be created on a 3D printer on bases of 3D scan. Use of&#xD;
      the protective tray would facilitate intubation, decrease anesthesiologic complications and&#xD;
      protect soft and hard tissues of the cleft palate and upper jaw during intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval by the Ethics Committee of the Brno University Hospital and registration at&#xD;
      clinicaltrials.gov, the study will include patients meeting inclusive criteria for whom&#xD;
      primary surgery for a cleft facial defect will be indicated.&#xD;
&#xD;
      Patients will be divided into two groups based on the type of surgery. Group 1 will include&#xD;
      patients with unilateral or bilateral cleft lip and alveolus (U/BCLA) or unilateral or&#xD;
      bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent primary lip&#xD;
      reconstruction within 0-3 months of age. Group 2 will include patients with isolated cleft&#xD;
      palate (ICP) and patients with U/BCLAP who underwent primary cleft reconstruction between 6&#xD;
      and 18 months of age.&#xD;
&#xD;
      Patients in the pediatric plastic surgery clinic of the Department of Pediatric Surgery,&#xD;
      Orthopedics and Traumatology will be randomized with a 1:1 allocation based on the day of&#xD;
      operation to the intervention group (3D protective obturator) and the control group (standard&#xD;
      procedure without the 3D obturator). Patients enrolled in the intervention group will have an&#xD;
      intraoral scan of the palate, alveolar arch, and upper vestibular area before surgery. Based&#xD;
      on this 3D visualization of precise anatomical conditions in the oral cavity, a form&#xD;
      (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a&#xD;
      protective obturator (splint), used during intubation to cover the defect of the alveolar&#xD;
      arch and palate will be created on a 3D printer, in cooperation with the Faculty of&#xD;
      Mechanical Engineering (Department of Mechanics of Bodies, Mechatronics and Biomechanics) of&#xD;
      Brno University of Technology. For the production of the obturator, a silicone certified for&#xD;
      use in the oral cavity will be used.&#xD;
&#xD;
      The main objective of the research will be to find out how the use of a protective obturator&#xD;
      (splint) will improve the protection of tissues at the cleft site and whether intubation will&#xD;
      be facilitated in pediatric patients with orofacial clefts with congenital atypical&#xD;
      anatomical conditions in the oral cavity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</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>Patient will be randomized according to the interventional and control goup according to the day of surgery. The allocation between the groups will be 1:1</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking will be included</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Degree of oral tissue injury during intubation</measure>
    <time_frame>Intraoperatively (after successful intubation)</time_frame>
    <description>specifically presence of petechiae, bleeding or soft tissue swelling after intubation in the entire cleft defect area, possibly premaxilla fracture in total cleft patients as a result of manipulation of the laryngoscope in the oral cavity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cormack-Lehane score</measure>
    <time_frame>Intraoperatively (during intubation)</time_frame>
    <description>Evaluation of the laryngoscopic image during intubation evaluated by the Cormack-Lehane score with or without the use of the protective tray. Cormack-Lehane scale range from 1 (ideal view - vocal cords) to 4 (the worst view of aditus laryngis, only the soft palate visible). For proper archiving of the intubation process, a photodocumentation of the laryngoscopic image during intubation will be taken for each patient using a video laryngoscope.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of intubations attempts</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>The number of intubation attempts to secure the airways (first successful intubation = first wave of end-tidal CO2) with and without the use of the protective tray will be evaluated</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of associated complications</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>The incidence of associated complications during induction of anesthesia - laryngospasm, bradycardia, severe desaturation &lt; 80 % oxygen saturation oxygen saturation by pulse oximetry pulse oximetry - SpO2 will be assessed</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Cleft Lip and Palate</condition>
  <arm_group>
    <arm_group_label>Intervention group (3D protective obturator)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients enrolled in the intervention group will have an intraoral scan of the palate, alveolar arch, and upper vestibular area before surgery. Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer, in cooperation with the Faculty of Mechanical Engineering (Department of Mechanics of Bodies, Mechatronics and Biomechanics) of Brno University of Technology. For the production of the obturator, a silicone certified for use in the oral cavity will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The standard procedure without the 3D obturator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D Obturator</intervention_name>
    <description>Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer</description>
    <arm_group_label>Intervention group (3D protective obturator)</arm_group_label>
    <other_name>3D printer obturator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients with unilateral or bilateral cleft lip and alveolus (U/BCLA) or&#xD;
             unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who&#xD;
             underwent primary lip reconstruction within 0-3 months of age (most often at our&#xD;
             workplace in the neonatal period)&#xD;
&#xD;
          -  Pediatric patients with isolated cleft palate (ICP) and patients with unilateral or&#xD;
             bilateral cleft lip, alveolus and palate (U/BCLAP) who underwent primary cleft&#xD;
             reconstruction between 6 and 18 months of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unilateral or bilateral cleft lip without cleft alveolus&#xD;
&#xD;
          -  patients with genetically confirmed syndrome disability&#xD;
&#xD;
          -  orofacial cleft patients with associated congenital malformations that may affect the&#xD;
             -course of anesthesia (atresia of the choanae)&#xD;
&#xD;
          -  patients with atypical clefts of the face&#xD;
&#xD;
          -  patients with CLA, CLAP, ICP who underwent primary cleft lip reconstruction later than&#xD;
             at 3 months of age&#xD;
&#xD;
          -  patients with CLAP and ICP who underwent primary cleft reconstruction later than at 18&#xD;
             months of age&#xD;
&#xD;
          -  patients with submucous cleft palate&#xD;
&#xD;
          -  patients with airways secured preoperatively&#xD;
&#xD;
          -  patients on artificial lung ventilation&#xD;
&#xD;
          -  patients with coagulopathy, thrombocytopenia/thrombocytopathy&#xD;
&#xD;
          -  patients at risk of malignant hyperthermia&#xD;
&#xD;
          -  patients for whom the consent of legal representatives to the research project has not&#xD;
             been obtained&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Petr Štourač, prof. MD., Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of medicince Masaryk University and University Hospital Brno</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michaela Richtorvá, MD.</last_name>
    <phone>532234693</phone>
    <phone_ext>00420</phone_ext>
    <email>richtrova.michaela@fnbrno.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Olga Košková, MD., Ph.D.</last_name>
    <phone>532234790</phone>
    <phone_ext>00420</phone_ext>
    <email>koskova.olga@fnbrno.cz</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Brno University Hospital</name>
      <address>
        <city>Brno</city>
        <state>South Moravian Region</state>
        <zip>62500</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Petr Štourač, doc.MD.P.hD.</last_name>
      <phone>532234404</phone>
      <phone_ext>00420</phone_ext>
      <email>stourac.petr@fnbrno.cz</email>
    </contact>
    <contact_backup>
      <last_name>Jozef Klučka, MD</last_name>
      <phone>532234696</phone>
      <phone_ext>00420</phone_ext>
      <email>klucka.jozef@fnbrno.cz</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brno University Hospital</investigator_affiliation>
    <investigator_full_name>Petr Štourač, MD</investigator_full_name>
    <investigator_title>assoc.prof.MD,Ph.D</investigator_title>
  </responsible_party>
  <keyword>3D print</keyword>
  <keyword>Cleft surgery</keyword>
  <keyword>Paediatric</keyword>
  <keyword>Airway</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Lip</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/NCT04422964
org study id: 3D Obturator Pilot
nct id: NCT04422964
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Congenital malformations of the orofacial area are the most common congenital malformations
      in children with an incidence of 1.8 children with orofacial cleft per 1000 healthy births in
      the Czech Republic. The care of children with cleft facial defects is multidisciplinary,
      centralized and takes place from birth to adulthood. At the University Hospital Brno, the
      treatment for patients with orofacial cleft is provided by the Cleft Center (CC) of the
      University Hospital Brno. The main specialties that form the basis of CC include plastic
      surgery, pediatric anesthesiology and neonatology. Patients with facial cleft defects are
      divided into 2 main groups based on the embryological causes of clefts: 1/ patients with
      cleft lip, jaw with or without cleft palate (total cleft) and 2/ patients with isolated cleft
      soft and hard palate. Anesthesia in children with orofacial clefts is specific not only to
      the age of the patients, but mainly to the cleft itself. Anesthesiology management, and
      especially intubation of these patients, are often difficult due to the nature of the defect
      with high incidence of complications such as difficult airway, desaturation, laryngospasm or
      bradycardia. In addition, tissue damage including soft tissue of the lip, alveolar arch,
      palate and nasal septum as well as skeleton of the premaxilla and nasal septum during
      intubation is seen in approximately 90% of patients. To facilitate intubation, improve
      anesthesiology management and safety of pediatric patients with orofacial cleft,
      investigators will develop an individualized protective tray from a silicone material, that
      will be used during intubation to cover the defect of the alveolar arch and palate. A mold
      for casting of a protective tray, will be created on a 3D printer on bases of 3D scan. Use of
      the protective tray would facilitate intubation, decrease anesthesiologic complications and
      protect soft and hard tissues of the cleft palate and upper jaw during intubation.
After approval by the Ethics Committee of the Brno University Hospital and registration at
      clinicaltrials.gov, the study will include patients meeting inclusive criteria for whom
      primary surgery for a cleft facial defect will be indicated.

      Patients will be divided into two groups based on the type of surgery. Group 1 will include
      patients with unilateral or bilateral cleft lip and alveolus (U/BCLA) or unilateral or
      bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent primary lip
      reconstruction within 0-3 months of age. Group 2 will include patients with isolated cleft
      palate (ICP) and patients with U/BCLAP who underwent primary cleft reconstruction between 6
      and 18 months of age.

      Patients in the pediatric plastic surgery clinic of the Department of Pediatric Surgery,
      Orthopedics and Traumatology will be randomized with a 1:1 allocation based on the day of
      operation to the intervention group (3D protective obturator) and the control group (standard
      procedure without the 3D obturator). Patients enrolled in the intervention group will have an
      intraoral scan of the palate, alveolar arch, and upper vestibular area before surgery. Based
      on this 3D visualization of precise anatomical conditions in the oral cavity, a form
      (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a
      protective obturator (splint), used during intubation to cover the defect of the alveolar
      arch and palate will be created on a 3D printer, in cooperation with the Faculty of
      Mechanical Engineering (Department of Mechanics of Bodies, Mechatronics and Biomechanics) of
      Brno University of Technology. For the production of the obturator, a silicone certified for
      use in the oral cavity will be used.

      The main objective of the research will be to find out how the use of a protective obturator
      (splint) will improve the protection of tissues at the cleft site and whether intubation will
      be facilitated in pediatric patients with orofacial clefts with congenital atypical
      anatomical conditions in the oral cavity.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patient will be randomized according to the interventional and control goup according to the day of surgery. The allocation between the groups will be 1:1
primary purpose: Supportive Care
masking: None (Open Label)
masking description: No masking will be included
measure: Degree of oral tissue injury during intubation
time frame: Intraoperatively (after successful intubation)
description: specifically presence of petechiae, bleeding or soft tissue swelling after intubation in the entire cleft defect area, possibly premaxilla fracture in total cleft patients as a result of manipulation of the laryngoscope in the oral cavity
measure: Cormack-Lehane score
time frame: Intraoperatively (during intubation)
description: Evaluation of the laryngoscopic image during intubation evaluated by the Cormack-Lehane score with or without the use of the protective tray. Cormack-Lehane scale range from 1 (ideal view - vocal cords) to 4 (the worst view of aditus laryngis, only the soft palate visible). For proper archiving of the intubation process, a photodocumentation of the laryngoscopic image during intubation will be taken for each patient using a video laryngoscope.
measure: Number of intubations attempts
time frame: Intraoperatively
description: The number of intubation attempts to secure the airways (first successful intubation = first wave of end-tidal CO2) with and without the use of the protective tray will be evaluated
measure: Incidence of associated complications
time frame: Intraoperatively
description: The incidence of associated complications during induction of anesthesia - laryngospasm, bradycardia, severe desaturation < 80 % oxygen saturation oxygen saturation by pulse oximetry pulse oximetry - SpO2 will be assessed
arm group label: Intervention group (3D protective obturator)
arm group type: Experimental
description: Patients enrolled in the intervention group will have an intraoral scan of the palate, alveolar arch, and upper vestibular area before surgery. Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer, in cooperation with the Faculty of Mechanical Engineering (Department of Mechanics of Bodies, Mechatronics and Biomechanics) of Brno University of Technology. For the production of the obturator, a silicone certified for use in the oral cavity will be used.
arm group label: control group
arm group type: No Intervention
description: The standard procedure without the 3D obturator.
intervention type: Device
intervention name: 3D Obturator
description: Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer
arm group label: Intervention group (3D protective obturator)
other name: 3D printer obturator
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Years
healthy volunteers: No
last name: Petr Štourač, prof. MD., Ph.D.
role: Study Chair
affiliation: Faculty of medicince Masaryk University and University Hospital Brno
last name: Michaela Richtorvá, MD.
phone: 532234693
phone ext: 00420
email: richtrova.michaela@fnbrno.cz
last name: Olga Košková, MD., Ph.D.
phone: 532234790
phone ext: 00420
email: koskova.olga@fnbrno.cz
facility: 
status: Recruiting
contact: 
contact backup: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Brno University Hospital
investigator full name: Petr Štourač, MD
investigator title: assoc.prof.MD,Ph.D
mesh term: Cleft Lip
sharing ipd: Undecided