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

Tobias Todsen

Status: Unknown

Conditions: Peritonsillar Abscess

Treatments: Procedure: The landmark technique; Diagnostic Test: Intraoral ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03824288

VD-2018-361

Details and patient eligibility

About

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)

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

The landmark technique

Active Comparator group

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.

Treatment:

Procedure: The landmark technique

Ultrasound-guided aspiration

Experimental group

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.

Treatment:

Diagnostic Test: Intraoral ultrasound