An interventional study of Intraoral ultrasound and The landmark technique in Peritonsillar Abscess, sponsored by Tobias Todsen. Status unknown at 2 sites in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Tobias Todsen · Not applicable, Interventional, and Diagnostic
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
149 studies on the registry are indexed under Abscess; 32 are open to participants now.
This study's planned enrollment of 88 is close to the median of 96 across 102 interventional studies indexed under Abscess.
Browse Abscess studies →Tobias Todsen is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Clinical findings of peritonsillar abscess by one of the following:
Exclusion criteria:
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
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.
A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted.
needle aspirations
total number of needle aspirations performed
Time frame: 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
Time frame: 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
Time frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
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.
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.
Number of visits in outpatient clinic
Time frame: 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).
Time frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Tobias Todsen