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

Peritonsillar Abscess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03824288
• Other study ID #: VD-2018-361
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: August 2019
• Source: Rigshospitalet, Denmark
• Contact: Tobias Todsen, MD, PhD
• Phone: 51847468
• Email: tobias.todsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: April 30, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Peritonsillar Abscess

Intervention

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.

Procedure:
• The landmark technique
A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Copenhagen East
Denmark	Odense University Hospital	Odense	Odense C

Sponsors (2)

Lead Sponsor	Collaborator
Tobias Todsen	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Number of hospitalization days		From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Secondary	Number of quincy tonsillectomies		From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Secondary	Number of visits in outpatient clinic		Until full recovery from peritonsilar infection
Secondary	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.