<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/NCT04406142</url>
  </required_header>
  <id_info>
    <org_study_id>CMC-17-0007-CTIL</org_study_id>
    <nct_id>NCT04406142</nct_id>
  </id_info>
  <brief_title>Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - the VISUAL Method</brief_title>
  <acronym>VISUAL</acronym>
  <official_title>Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - a Prospective, Multicenter Trial, Assessing the Feasibility of the VISUAL Method (Video Surfactant Administration Laryngoscopy)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carmel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carmel Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surfactant administration via thin catheter using a specially adapted video laryngoscope - a&#xD;
      prospective, multicenter trial, assessing the feasibility of the VISUAL method (Video&#xD;
      Surfactant Administration Laryngoscopy).&#xD;
&#xD;
      The study will search for the number of attempts until surfactant is administrated,&#xD;
      assessment of the infants' stability during the procedure, duration of the entire procedure,&#xD;
      form laryngoscope insertion to surfactant administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study the investigators intend to assess the feasibility of surfactant administration&#xD;
      via a thin catheter using a specially adapted video laryngoscope, with a groove designed to&#xD;
      allow insertion of an endovascular catheter without the use of other instruments in the oral&#xD;
      cavity (forceps ect.).&#xD;
&#xD;
      The laryngoscope is manufactured by Peak Medic Ltd, Natania, Israel.&#xD;
&#xD;
      Primary Endpoints&#xD;
&#xD;
        1. - Number of attempts until surfactant is administrated&#xD;
&#xD;
        2. - Assessment of the infants' stability during the procedure - saturation, bradycardia,&#xD;
           tachycardia.&#xD;
&#xD;
        3. - Duration of the entire procedure, form laryngoscope insertion to surfactants&#xD;
           administration.&#xD;
&#xD;
      4. Secondary Endpoints&#xD;
&#xD;
        1. - Need of invasive mechanical ventilation in the next 24 hours.&#xD;
&#xD;
        2. - Complications reports&#xD;
&#xD;
        3. - Subjective procedure scale of assessment&#xD;
&#xD;
        4. - Unexpected pitfalls reports&#xD;
&#xD;
        5. - Safety assessment of the procedure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2018</start_date>
  <completion_date type="Actual">February 28, 2022</completion_date>
  <primary_completion_date type="Actual">February 28, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Feasibility study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary outcome measures</measure>
    <time_frame>1 year</time_frame>
    <description>Success for surfactant administration - yes / no</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome measures 1</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment of the infants' SPO2 %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome measures 2</measure>
    <time_frame>1 year</time_frame>
    <description>Heart rate during the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome measures 3</measure>
    <time_frame>1 year</time_frame>
    <description>Respiratory rate (breaths per minute)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome measures 4</measure>
    <time_frame>1 year</time_frame>
    <description>number of attempts for vocal cords visualization (number)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome measures 5</measure>
    <time_frame>1 year</time_frame>
    <description>Duration of the procedure (seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome measures 6</measure>
    <time_frame>1 year</time_frame>
    <description>Need for mechanical ventilaton witin 24 hours following procedure (yes-no)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Respiratory Distress Syndrome, Newborn</condition>
  <arm_group>
    <arm_group_label>treatment feasibility</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>feasibility, safety and effectiveness assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VISUAL</intervention_name>
    <description>thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy</description>
    <arm_group_label>treatment feasibility</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. - Premature infants with gestational age 30-36 weeks.&#xD;
&#xD;
          2. - Diagnosis of respiratory distress syndrome&#xD;
&#xD;
          3. - Spontaneously breathing with non-invasive positive pressure ventilation.&#xD;
&#xD;
          4. - Maximal age 3 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. - Apgar score at 5 min &lt; 5&#xD;
&#xD;
          2. - Need for chest compressions or medication upon delivery.&#xD;
&#xD;
          3. - Evident major congenital malformation, metabolic or genetic disorders.&#xD;
&#xD;
          4. - Clinical evidence of sepsis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dan I Waisman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neonatology, Carmel Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neonatology, Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>February 10, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>March 13, 2022</last_update_submitted>
  <last_update_submitted_qc>March 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carmel Medical Center</investigator_affiliation>
    <investigator_full_name>Dany Waisman</investigator_full_name>
    <investigator_title>Director of the Newborn Unit Department of Neonatology</investigator_title>
  </responsible_party>
  <keyword>respiratory distress syndrome</keyword>
  <keyword>videolaryngoscopy</keyword>
  <keyword>newborn infant</keyword>
  <keyword>premature newborn infant</keyword>
  <keyword>surfactant administration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
  </condition_browse>
  <!-- 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/NCT04406142
org study id: CMC-17-0007-CTIL
nct id: NCT04406142
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Surfactant administration via thin catheter using a specially adapted video laryngoscope - a
      prospective, multicenter trial, assessing the feasibility of the VISUAL method (Video
      Surfactant Administration Laryngoscopy).

      The study will search for the number of attempts until surfactant is administrated,
      assessment of the infants' stability during the procedure, duration of the entire procedure,
      form laryngoscope insertion to surfactant administration.
In this study the investigators intend to assess the feasibility of surfactant administration
      via a thin catheter using a specially adapted video laryngoscope, with a groove designed to
      allow insertion of an endovascular catheter without the use of other instruments in the oral
      cavity (forceps ect.).

      The laryngoscope is manufactured by Peak Medic Ltd, Natania, Israel.

      Primary Endpoints

        1. - Number of attempts until surfactant is administrated

        2. - Assessment of the infants' stability during the procedure - saturation, bradycardia,
           tachycardia.

        3. - Duration of the entire procedure, form laryngoscope insertion to surfactants
           administration.

      4. Secondary Endpoints

        1. - Need of invasive mechanical ventilation in the next 24 hours.

        2. - Complications reports

        3. - Subjective procedure scale of assessment

        4. - Unexpected pitfalls reports

        5. - Safety assessment of the procedure
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Feasibility study
primary purpose: Treatment
masking: None (Open Label)
measure: Primary outcome measures
time frame: 1 year
description: Success for surfactant administration - yes / no
measure: Secondary outcome measures 1
time frame: 1 year
description: Assessment of the infants' SPO2 %
measure: Secondary outcome measures 2
time frame: 1 year
description: Heart rate during the procedure
measure: Secondary outcome measures 3
time frame: 1 year
description: Respiratory rate (breaths per minute)
measure: Secondary outcome measures 4
time frame: 1 year
description: number of attempts for vocal cords visualization (number)
measure: Secondary outcome measures 5
time frame: 1 year
description: Duration of the procedure (seconds)
measure: Secondary outcome measures 6
time frame: 1 year
description: Need for mechanical ventilaton witin 24 hours following procedure (yes-no)
arm group label: treatment feasibility
arm group type: Experimental
description: feasibility, safety and effectiveness assessment
intervention type: Device
intervention name: VISUAL
description: thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy
arm group label: treatment feasibility
criteria: 
gender: All
minimum age: N/A
maximum age: 3 Days
healthy volunteers: No
last name: Dan I Waisman, MD
role: Principal Investigator
affiliation: Department of Neonatology, Carmel Medical Center
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Carmel Medical Center
investigator full name: Dany Waisman
investigator title: Director of the Newborn Unit Department of Neonatology
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn