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

Study Overview
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Brief Summary
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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)

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

Conditions
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Peritonsillar Abscess

Intervention / Treatment
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* Diagnostic Test: Intraoral ultrasound
* Procedure: The landmark technique


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar abscess Clinical findings of peritonsillar abscess by one of the following: Trismus 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The landmark technique<br>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<br>* A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted.<br>|
| Experimental: Ultrasound-guided aspiration<br>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<br>* 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.<br>|

What is the study measuring?
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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. |