<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/NCT01698892</url>
  </required_header>
  <id_info>
    <org_study_id>12_0208</org_study_id>
    <nct_id>NCT01698892</nct_id>
  </id_info>
  <brief_title>Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy. (TORSIV)</brief_title>
  <acronym>TORSIV</acronym>
  <official_title>Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bronchoscopy is a technique which currently allows the investigation of many respiratory&#xD;
      diseases (infections, neoplasia, inflammation…) as well as endobronchial therapeutic&#xD;
      procedures.&#xD;
&#xD;
      Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication&#xD;
      before endoscopy, but practices concerning the use of sedation further to the completion of&#xD;
      the endoscopy are very heterogeneous.&#xD;
&#xD;
      We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to&#xD;
      I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of dyspnea</measure>
    <time_frame>1 day</time_frame>
    <description>Intensity of dyspnea assessed by the patient 1h after bronchoscopy in both groups measured by VAS (visual analogue scale) score (in millimeters on a 0 to 100 scale).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS Individual scores</measure>
    <time_frame>1 day</time_frame>
    <description>VAS Individual scores performed 1 hour after bronchoscopy (cough, nausea, pain, anxiety, overall tolerance)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>1 day</time_frame>
    <description>Blood pressure (mean blood pressure measurements made before, during and after the exam)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Desaturation frequency</measure>
    <time_frame>1 day</time_frame>
    <description>Desaturation frequency during bronchoscopy, defined by the lowering of transcutaneous oxygen saturation below 90%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>1 day</time_frame>
    <description>Initial and maximum heart rate during bronchoscopy (continuous monitoring)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OAAS Score</measure>
    <time_frame>1 day</time_frame>
    <description>OAAS Score after bronchoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchoscopy duration</measure>
    <time_frame>1 day</time_frame>
    <description>Bronchoscopy duration (time difference between the input and output of the examination room, and between the start and end of bronchoscopy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of midazolam total dose</measure>
    <time_frame>1 day</time_frame>
    <description>Comparison of midazolam total dose administered in each group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Sedation During Bronchoscopy</condition>
  <arm_group>
    <arm_group_label>I.V. sedation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sublingual sedation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>I.V Sedation</intervention_name>
    <description>Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation group</description>
    <arm_group_label>I.V. sedation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sublingual sedation</intervention_name>
    <description>Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group</description>
    <arm_group_label>sublingual sedation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women aged between 18 and 80, who will undergo bronchoscopy&#xD;
&#xD;
          -  FEV1≥ 50% of theorical value&#xD;
&#xD;
          -  Ambient air saturation at rest ≥ 94%&#xD;
&#xD;
          -  No allergy to midazolam, to hydroxyzine, Lidocaine (used for local anesthesia) or one&#xD;
             of their compound&#xD;
&#xD;
          -  fasting for at least 6 hours&#xD;
&#xD;
          -  No indication against bronchoscopy, nor to premedication&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating, women&#xD;
&#xD;
          -  PAH patients&#xD;
&#xD;
          -  patients undergoing bronchoscopy with bronchoalveolar lavage and / or trans-bronchial&#xD;
             biopsy&#xD;
&#xD;
          -  Patients with oral anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cavailles</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>June 5, 2015</last_update_submitted>
  <last_update_submitted_qc>June 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>I.V. sedation, midazolam, bronchoscopy</keyword>
  <!-- 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/NCT01698892
org study id: 12_0208
nct id: NCT01698892
lead sponsor: 
has dmc: Yes
Bronchoscopy is a technique which currently allows the investigation of many respiratory
      diseases (infections, neoplasia, inflammation…) as well as endobronchial therapeutic
      procedures.

      Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication
      before endoscopy, but practices concerning the use of sedation further to the completion of
      the endoscopy are very heterogeneous.

      We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to
      I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Intensity of dyspnea
time frame: 1 day
description: Intensity of dyspnea assessed by the patient 1h after bronchoscopy in both groups measured by VAS (visual analogue scale) score (in millimeters on a 0 to 100 scale).
measure: VAS Individual scores
time frame: 1 day
description: VAS Individual scores performed 1 hour after bronchoscopy (cough, nausea, pain, anxiety, overall tolerance)
measure: Blood pressure
time frame: 1 day
description: Blood pressure (mean blood pressure measurements made before, during and after the exam)
measure: Desaturation frequency
time frame: 1 day
description: Desaturation frequency during bronchoscopy, defined by the lowering of transcutaneous oxygen saturation below 90%
measure: heart rate
time frame: 1 day
description: Initial and maximum heart rate during bronchoscopy (continuous monitoring)
measure: OAAS Score
time frame: 1 day
description: OAAS Score after bronchoscopy
measure: Bronchoscopy duration
time frame: 1 day
description: Bronchoscopy duration (time difference between the input and output of the examination room, and between the start and end of bronchoscopy)
measure: Comparison of midazolam total dose
time frame: 1 day
description: Comparison of midazolam total dose administered in each group
arm group label: I.V. sedation
arm group type: Experimental
description: Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation
arm group label: sublingual sedation
arm group type: Active Comparator
description: Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group
intervention type: Drug
intervention name: I.V Sedation
description: Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation group
arm group label: I.V. sedation
intervention type: Drug
intervention name: sublingual sedation
description: Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group
arm group label: sublingual sedation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor