Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT

A Randomized Multicenter Trial of Ultrasound-Guided Aspiration of Peritonsillar Abscess Versus Conventional Landmark Technique

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)

Study Overview

• Status: Unknown
• Conditions: Peritonsillar Abscess
• Intervention / Treatment: Procedure: The landmark technique; Diagnostic test: Intraoral ultrasound

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobias Todsen, MD, PhD; Phone Number: 51847468; Email: tobias.todsen@regionh.dk

Study Locations

• Denmark
  • Copenhagen East
    • Copenhagen, Copenhagen East, Denmark, 2100
      • Recruiting
      • Rigshospitalet
  • Odense C
    • Odense, Odense C, Denmark, 5000
      • Recruiting
      • Odense University Hospital
      • Contact: Sanne H Michaelsen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar abscess

• Clinical findings of peritonsillar abscess by one of the following:

  1. Trismus
  2. Unilateral tonsillar/peritonsillar swelling

Exclusion criteria:

• Compromised airways or suspected retro / parapharyngeal abscess
• Needle aspiration of pus already performed (or participated in the study once earlier)
• Cannot understand the written information

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: The landmark technique; 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.	Procedure: The landmark technique; A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted.
EXPERIMENTAL: Ultrasound-guided aspiration; 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.	Diagnostic test: Intraoral ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
needle aspirations	total number of needle aspirations performed	From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
proportion of succesfull needle aspirations	proportion of needle aspirations with aspiration of pus	From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
days on sick leave	Total number of days on sick leave after first intervention	From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hospitalization days		From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Number of quincy tonsillectomies		From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Number of visits in outpatient clinic		Until full recovery from peritonsilar infection
Patient-reported outcome	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).	From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.

Collaborators and Investigators

• Sponsor: Tobias Todsen
• Collaborators: Odense University Hospital

Publications and helpful links

General Publications

• Todsen T, Stage MG, Michaelsen SH, Tolsgaard MG, Melchiors J, Madsen AR, Hahn CH, Godballe C. Protocol for a randomised clinical trial of transoral ultrasound versus standard of care in the diagnosis of peritonsillar abscess. Dan Med J. 2019 Nov;66(11):A5573.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 26, 2018
• Primary Completion (ANTICIPATED): August 30, 2019
• Study Completion (ANTICIPATED): April 30, 2020

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (ACTUAL): January 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Inflammation; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Suppuration; Pharyngitis; Tonsillitis; Abscess; Peritonsillar Abscess
• Other Study ID Numbers: VD-2018-361

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No