Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess
Recruiting now · Not applicable
Conditions studied: Peritonsillar Abscess, Peritonsillar Cellulitis, Tonsillitis
In brief
Peritonsillar abscess (PTA) is a collection of pus between the palatine tonsil and the constrictor muscle. PTA is detected by recognizing characteristics during clinical examination: redness, pain, malaise, trismus, and unilateral peritonsillar swelling. Clinical assessment, including inspection and palpation, is the traditional diagnostic method for patients suspected of having PTA. If PTA is suspected, aspiration with a large-gauge needle or incision is performed to drain the abscess . It can be challenging to distinguish PTA and peritonsillar cellulitis (PTC) based on clinical examination alone. Due to the increased availability of point-of-care ultrasound, it is a part of the diagnostic workup of PTA. Several studies have shown that transoral US can improve the diagnostic accuracy of patients with a suspected PTA. However, no large multicenter study has evaluated whether one of these methods is superior to the other. It is therefore very clinician-dependent whether the patient will have a transoral US performed or not. The investigators hypothesize that transoral US will increase the diagnostic accuracy of PTA compared to solely clinical examination, which is a visual and palpatory assessment. This will result in fewer unnecessary aspiration attempts and overlooked PTAs. Additionally, the investigators wish to investigate the number of aspirations of transoral US-guided needle aspirations compared to aspirations without ultrasound. Methods This is a cluster randomized study. Patients with suspected PTA will be randomized 1:1 to groups A and B. The cluster randomization will happen weekly using an online randomization tool. Participants are patients refeered to the outpatient clinic on suspicion of a peritonsillar absces. The primary outcome is the diagnostic accuracy The investigators aim to determine whether transoral US is a standard part of the clinical examination by comparing clinical examinations with and without US.
Key facts
- Study ID
- NCT07577232
- Run by
- Rigshospitalet, Denmark
- People needed
- 368
- Starts
- 2025-06-09
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients referred to the ENT outpatient clinic with a suspected PTA.
- 18 years of age or older.
You may not qualify if…
- Unable to understand the verbal information, participating in research.
- Prior surgical interventions (needle aspiration, surgery, incision) during the course of the disease.
- Compromised airways, needing acute airway management.
Where it is running
- Department of Otorhinolaryngology, Head and Neck Surgery & Audiolog — Copenhagen, Denmark (enrolling)
- Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, North Zealand Hospital — Hillerød, Denmark (enrolling)
- Department of ORL - Head & Neck Surgery and Audiology, Zealand University Hospital, — Køge, Denmark
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.