<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/NCT02246023</url>
  </required_header>
  <id_info>
    <org_study_id>BronchoPropTCI</org_study_id>
    <secondary_id>SNCTP000000706</secondary_id>
    <nct_id>NCT02246023</nct_id>
  </id_info>
  <brief_title>Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy</brief_title>
  <official_title>Target-controlled Versus Manually-controlled Propofol Sedation in Flexible Bronchoscopy. A Randomized Non-inferiority Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daniel Franzen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>B. Braun Melsungen AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After randomization, the subjects undergo flexible bronchoscopy either with fractionated&#xD;
      propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate,&#xD;
      oxygen saturation, and oxygen requirement are measured continuously during the procedure and&#xD;
      thereafter. Cumulative propofol dose, and induction, procedure, and recovery time are noted&#xD;
      continuously during and after the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In daily clinical praxis, propofol sedation is given manually in repeated doses&#xD;
      (fractionated) by a specially-trained nurse in attendance of the bronchoscopist. But,&#xD;
      fractionated propofol administration (FPA) may lead to oversedation and enhanced side effects&#xD;
      (oxygen desaturation and arterial hypotension), as a stable plasma concentration of propofol&#xD;
      is not maintainable. In contrast to FPA, continuous infusions of propofol are commonly used&#xD;
      to induce and maintain long-term sedation in intensive care units and general anesthesia.&#xD;
      Recently, continuous propofol infusion for sedation in bronchoscopy has been shown comparable&#xD;
      to FPA in terms of safety and efficacy. Generally, infusion devices can be manually&#xD;
      controlled (MCI) or target-controlled (TCI). In the latter, the physician sets a target blood&#xD;
      concentration and the computerized infusion device makes the necessary changes to the&#xD;
      infusion rate.&#xD;
&#xD;
      The objective of this study is to compare propofol TCI with FPA in flexible bronchoscopy&#xD;
      concerning patient safety and sedation quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean arterial oxygen saturation</measure>
    <time_frame>During bronchoscopy</time_frame>
    <description>From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of occasions with recorded an oxygen saturation of &lt; 90%</measure>
    <time_frame>During bronchoscopy</time_frame>
    <description>From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of an oxygen desaturation of &gt; 4% from baseline</measure>
    <time_frame>During bronchoscopy</time_frame>
    <description>From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of occasions with a systolic blood pressure &lt; 90 mmHg during bronchoscopy, maximum oxygen requirement,</measure>
    <time_frame>During bronchoscopy</time_frame>
    <description>From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of dose adjustments</measure>
    <time_frame>During bronchoscopy</time_frame>
    <description>From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative propofol dose</measure>
    <time_frame>At end of bronchoscopy</time_frame>
    <description>At time point when bronchoscope is removed (on average after 45 minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery time after bronchoscopy</measure>
    <time_frame>During 2 hours after bronchoscopy</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Sarcoidosis</condition>
  <condition>Interstitial Pneumonia</condition>
  <arm_group>
    <arm_group_label>Fractionated propofol administration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Flexible bronchoscopy in moderate sedation with fractionated propofol administrations: Patients receive an initial 20 mg of propofol, followed by a carefully titrated dose of10-20 mg propofol based on the clinical response.&#xD;
Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol-TCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Flexible bronchoscopy in moderate sedation with TCI propofol perfusor:&#xD;
Flexible bronchoscopy is started after reaching the initial targeted effect-site concentration (Ce) of 2.5 μg/mL using the Schnider pharmacokinetic model described elsewhere. Thereafter, Ce is adjusted by increments of 0.2 μg/mL depending on the clinical effect, in order to maintain the required level of sedation.&#xD;
Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy The propofol-TCI perfusor is an active infusion system for fluid management. In the study, the Perfusor® Space of B. Braun AG, Melsungen is used exclusively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Flexible bronchoscopy in moderate sedation</intervention_name>
    <description>Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;</description>
    <arm_group_label>Fractionated propofol administration</arm_group_label>
    <arm_group_label>Propofol-TCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oxygen saturation</intervention_name>
    <description>Continuous measurement of oxygen saturation;</description>
    <arm_group_label>Fractionated propofol administration</arm_group_label>
    <arm_group_label>Propofol-TCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood pressure</intervention_name>
    <description>Measurement of non-invasive blood pressure every 3 minutes</description>
    <arm_group_label>Fractionated propofol administration</arm_group_label>
    <arm_group_label>Propofol-TCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Propofol dosage</intervention_name>
    <description>Report of dose adjustments und cumulative propofol dosage;</description>
    <arm_group_label>Fractionated propofol administration</arm_group_label>
    <arm_group_label>Propofol-TCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Recovery time after bronchoscopy</intervention_name>
    <description>Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)</description>
    <arm_group_label>Fractionated propofol administration</arm_group_label>
    <arm_group_label>Propofol-TCI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects undergoing a planned, ambulatory flexible bronchoscopy (for transbronchial&#xD;
             lung biopsy or endobronchial ultrasound guided procedures) in moderate sedation, aged&#xD;
             between 18 and 85 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of solid organ or bone marrow transplantation with the use of an&#xD;
             immunosuppressive therapy&#xD;
&#xD;
          -  HIV infection on anti-retroviral therapy&#xD;
&#xD;
          -  Alcohol consumption more than two standard drinks per day&#xD;
&#xD;
          -  Use of illicit drugs (heroin, opiates)&#xD;
&#xD;
          -  Any contraindication to use propofol for sedation (e.g. allergy)&#xD;
&#xD;
          -  Body mass index &gt; 35 kg/m2&#xD;
&#xD;
          -  Mental disorder preventing appropriate judgment concerning study participation&#xD;
&#xD;
          -  Missing written patient's informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Franzen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Pulmonology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>April 13, 2016</last_update_submitted>
  <last_update_submitted_qc>April 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Daniel Franzen</investigator_full_name>
    <investigator_title>Dr. Daniel Franzen</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
    <mesh_term>Sarcoidosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
  </intervention_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/NCT02246023
org study id: BronchoPropTCI
secondary id: SNCTP000000706
nct id: NCT02246023
lead sponsor: 
collaborator: 
has dmc: Yes
After randomization, the subjects undergo flexible bronchoscopy either with fractionated
      propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate,
      oxygen saturation, and oxygen requirement are measured continuously during the procedure and
      thereafter. Cumulative propofol dose, and induction, procedure, and recovery time are noted
      continuously during and after the procedure.
In daily clinical praxis, propofol sedation is given manually in repeated doses
      (fractionated) by a specially-trained nurse in attendance of the bronchoscopist. But,
      fractionated propofol administration (FPA) may lead to oversedation and enhanced side effects
      (oxygen desaturation and arterial hypotension), as a stable plasma concentration of propofol
      is not maintainable. In contrast to FPA, continuous infusions of propofol are commonly used
      to induce and maintain long-term sedation in intensive care units and general anesthesia.
      Recently, continuous propofol infusion for sedation in bronchoscopy has been shown comparable
      to FPA in terms of safety and efficacy. Generally, infusion devices can be manually
      controlled (MCI) or target-controlled (TCI). In the latter, the physician sets a target blood
      concentration and the computerized infusion device makes the necessary changes to the
      infusion rate.

      The objective of this study is to compare propofol TCI with FPA in flexible bronchoscopy
      concerning patient safety and sedation quality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Mean arterial oxygen saturation
time frame: During bronchoscopy
description: From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
measure: Number of occasions with recorded an oxygen saturation of < 90%
time frame: During bronchoscopy
description: From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
measure: Number of an oxygen desaturation of > 4% from baseline
time frame: During bronchoscopy
description: From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
measure: Number of occasions with a systolic blood pressure < 90 mmHg during bronchoscopy, maximum oxygen requirement,
time frame: During bronchoscopy
description: From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
measure: Frequency of dose adjustments
time frame: During bronchoscopy
description: From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
measure: Cumulative propofol dose
time frame: At end of bronchoscopy
description: At time point when bronchoscope is removed (on average after 45 minutes)
measure: Recovery time after bronchoscopy
time frame: During 2 hours after bronchoscopy
arm group label: Fractionated propofol administration
arm group type: Active Comparator
description: Flexible bronchoscopy in moderate sedation with fractionated propofol administrations: Patients receive an initial 20 mg of propofol, followed by a carefully titrated dose of10-20 mg propofol based on the clinical response.
Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy
arm group label: Propofol-TCI
arm group type: Experimental
description: Flexible bronchoscopy in moderate sedation with TCI propofol perfusor:
Flexible bronchoscopy is started after reaching the initial targeted effect-site concentration (Ce) of 2.5 μg/mL using the Schnider pharmacokinetic model described elsewhere. Thereafter, Ce is adjusted by increments of 0.2 μg/mL depending on the clinical effect, in order to maintain the required level of sedation.
Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy The propofol-TCI perfusor is an active infusion system for fluid management. In the study, the Perfusor® Space of B. Braun AG, Melsungen is used exclusively.
intervention type: Device
intervention name: Flexible bronchoscopy in moderate sedation
description: Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;
arm group label: Fractionated propofol administration
arm group label: Propofol-TCI
intervention type: Device
intervention name: Oxygen saturation
description: Continuous measurement of oxygen saturation;
arm group label: Fractionated propofol administration
arm group label: Propofol-TCI
intervention type: Device
intervention name: Blood pressure
description: Measurement of non-invasive blood pressure every 3 minutes
arm group label: Fractionated propofol administration
arm group label: Propofol-TCI
intervention type: Device
intervention name: Propofol dosage
description: Report of dose adjustments und cumulative propofol dosage;
arm group label: Fractionated propofol administration
arm group label: Propofol-TCI
intervention type: Device
intervention name: Recovery time after bronchoscopy
description: Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)
arm group label: Fractionated propofol administration
arm group label: Propofol-TCI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Daniel Franzen, MD
role: Principal Investigator
affiliation: Division of Pulmonology
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University of Zurich
investigator full name: Daniel Franzen
investigator title: Dr. Daniel Franzen
mesh term: Lung Diseases, Interstitial
mesh term: Sarcoidosis
mesh term: Propofol