<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/NCT03824288</url>
  </required_header>
  <id_info>
    <org_study_id>VD-2018-361</org_study_id>
    <nct_id>NCT03824288</nct_id>
  </id_info>
  <brief_title>Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT</brief_title>
  <official_title>A Randomized Multicenter Trial of Ultrasound-Guided Aspiration of Peritonsillar Abscess Versus Conventional Landmark Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tobias Todsen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</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>
      The study is a prospective randomized controlled trial conducted at two different centers at&#xD;
      the Department of ORL - Head &amp; Neck Surgery, Odense University Hospital and the Department of&#xD;
      Otorhinolaryngology, Head and Neck Surgery &amp; Audiology, Rigshospitalet.&#xD;
&#xD;
      The research question is:&#xD;
&#xD;
      In a group of patients referred to an otolaryngology department with objective findings of&#xD;
      peritonsillar abscess, what are the effects of using intraoral ultrasound to diagnose and&#xD;
      guide needle aspiration compared to the traditional landmark-based technique, when measured&#xD;
      by the number of performed needle aspirations, procedure-related pain and days on sick leave?&#xD;
&#xD;
      The secondary outcomes measured are&#xD;
&#xD;
        -  Number of hospitalization days&#xD;
&#xD;
        -  Number of Quincy tonsillectomies&#xD;
&#xD;
        -  Number of visits to an outpatient clinic&#xD;
&#xD;
        -  Patient-reported outcome (measured using an 11-point numeric rating scale)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2019</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>needle aspirations</measure>
    <time_frame>From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.</time_frame>
    <description>total number of needle aspirations performed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>proportion of succesfull needle aspirations</measure>
    <time_frame>From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.</time_frame>
    <description>proportion of needle aspirations with aspiration of pus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>days on sick leave</measure>
    <time_frame>From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.</time_frame>
    <description>Total number of days on sick leave after first intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalization days</measure>
    <time_frame>From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of quincy tonsillectomies</measure>
    <time_frame>From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of visits in outpatient clinic</measure>
    <time_frame>Until full recovery from peritonsilar infection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported outcome</measure>
    <time_frame>From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.</time_frame>
    <description>Patients are asked to choose one number, on a scale from 0 (no pain) to 10 (severe pain), corresponding to the intensity of their pain - meassured using a 11-point numeric rating scale (NRS-11).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Peritonsillar Abscess</condition>
  <arm_group>
    <arm_group_label>The landmark technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PTA a needle aspiration attempted according to the landmark technique is conducted. If the initial aspiration is unsuccessful, two additional attempts are made in the middle and lower pole of the tonsil.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound-guided aspiration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An intraoral ultrasound is conducted with a Burr-Hole N11C5s transducer (BK Ultrasound) and if an abscess cavity is suspected, an ultrasound-guided aspiration is performed with an in-plane needle guide attached to guide the needle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Intraoral ultrasound</intervention_name>
    <description>The ultrasound transducer (either Hockey Stick or Burr-Hole N11C5s transducer from BK Ultrasound) is placed on the palatoglossal arch on the affected side and sweeped from the cranial to caudal end of the tonsil to look for an abscess cavity identified as a hypoechoic area with ill-defined margins.</description>
    <arm_group_label>Ultrasound-guided aspiration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The landmark technique</intervention_name>
    <description>A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted.</description>
    <arm_group_label>The landmark technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar&#xD;
             abscess&#xD;
&#xD;
          -  Clinical findings of peritonsillar abscess by one of the following:&#xD;
&#xD;
               1. Trismus&#xD;
&#xD;
               2. Unilateral tonsillar/peritonsillar swelling&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Compromised airways or suspected retro / parapharyngeal abscess&#xD;
&#xD;
          -  Needle aspiration of pus already performed (or participated in the study once earlier)&#xD;
&#xD;
          -  Cannot understand the written information&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tobias Todsen, MD, PhD</last_name>
    <phone>51847468</phone>
    <email>tobias.todsen@regionh.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <state>Copenhagen East</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tobias Todsen, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <state>Odense C</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sanne H Michaelsen, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>August 19, 2019</last_update_submitted>
  <last_update_submitted_qc>August 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Tobias Todsen</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abscess</mesh_term>
    <mesh_term>Peritonsillar Abscess</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/NCT03824288
org study id: VD-2018-361
nct id: NCT03824288
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study is a prospective randomized controlled trial conducted at two different centers at
      the Department of ORL - Head & Neck Surgery, Odense University Hospital and the Department of
      Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet.

      The research question is:

      In a group of patients referred to an otolaryngology department with objective findings of
      peritonsillar abscess, what are the effects of using intraoral ultrasound to diagnose and
      guide needle aspiration compared to the traditional landmark-based technique, when measured
      by the number of performed needle aspirations, procedure-related pain and days on sick leave?

      The secondary outcomes measured are

        -  Number of hospitalization days

        -  Number of Quincy tonsillectomies

        -  Number of visits to an outpatient clinic

        -  Patient-reported outcome (measured using an 11-point numeric rating scale)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Investigator, Outcomes Assessor)
measure: needle aspirations
time frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
description: total number of needle aspirations performed
measure: proportion of succesfull needle aspirations
time frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
description: proportion of needle aspirations with aspiration of pus
measure: days on sick leave
time frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
description: Total number of days on sick leave after first intervention
measure: Number of hospitalization days
time frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
measure: Number of quincy tonsillectomies
time frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
measure: Number of visits in outpatient clinic
time frame: Until full recovery from peritonsilar infection
measure: Patient-reported outcome
time frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
description: Patients are asked to choose one number, on a scale from 0 (no pain) to 10 (severe pain), corresponding to the intensity of their pain - meassured using a 11-point numeric rating scale (NRS-11).
arm group label: The landmark technique
arm group type: Active Comparator
description: PTA a needle aspiration attempted according to the landmark technique is conducted. If the initial aspiration is unsuccessful, two additional attempts are made in the middle and lower pole of the tonsil.
arm group label: Ultrasound-guided aspiration
arm group type: Experimental
description: An intraoral ultrasound is conducted with a Burr-Hole N11C5s transducer (BK Ultrasound) and if an abscess cavity is suspected, an ultrasound-guided aspiration is performed with an in-plane needle guide attached to guide the needle.
intervention type: Diagnostic Test
intervention name: Intraoral ultrasound
description: The ultrasound transducer (either Hockey Stick or Burr-Hole N11C5s transducer from BK Ultrasound) is placed on the palatoglossal arch on the affected side and sweeped from the cranial to caudal end of the tonsil to look for an abscess cavity identified as a hypoechoic area with ill-defined margins.
arm group label: Ultrasound-guided aspiration
intervention type: Procedure
intervention name: The landmark technique
description: A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted.
arm group label: The landmark technique
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tobias Todsen, MD, PhD
phone: 51847468
email: tobias.todsen@regionh.dk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Tobias Todsen
investigator title: MD, PhD
mesh term: Abscess
mesh term: Peritonsillar Abscess