Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess
Condition(s) studied
Investigational drug(s) / intervention(s)
Transoral Ultrasound: A small hockey stick ultrasound to scan the oropharynx through the mouth
Study summary
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.
Eligibility
Primary outcome measure(s)
- Diagnostic accuracy — From date of randomization until the treatment is completed, assessed up to 2 months.
Diagnostic accuracy (sensitivity and specificity) of PTA when performing transoral US and by clinical evaluation. A final PTA diagnosis is defined as pus retriveal on the first visit in the outpatient clinic or follow up visit. No later than four days after inclusion. A final non-PTa diagnosis is defined as disease resolution with conservative treatment
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Otorhinolaryngology, Head and Neck Surgery & Audiolog | Copenhagen | Denmark | Recruiting |
| Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, North Zealand Hospital | Hillerød | Denmark | Recruiting |
| Department of ORL - Head & Neck Surgery and Audiology, Zealand University Hospital, | Køge | Denmark | Not Yet Recruiting |
More Copenhagen University Hospital, Rigshospitalet trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07577232 on ClinicalTrials.gov ↗ ← All trials in Denmark