Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients referred to the ENT outpatient clinic with a suspected PTA.
18 years of age or older.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Transoral Ultrasound
DeviceA small hockey stick ultrasound to scan the oropharynx through the mouth
Treatment groups
368 Participants
are divided into 2 treatment groupsGroup A: Intervention/clinical investigation with ultrasoundExperimental treatment 1 intervention
Group B: Investigation without ultrasound. Control group.Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic accuracy
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
Time frame
From date of randomization until the treatment is completed, assessed up to 2 months.Secondary outcomes
1
Number of patients undergoing surgery (tons a chaud)
Number of patients undergoing surgery (tons a chaud). A comparison of the two study arms.
Time frame
From date of randomization until the treatment is completed, assessed up to 2 months.2
Number of positive needle aspirations
Number of positive needle aspirations. A comparison of the two study arms.
Time frame
Day 13
Number of hospital visits
Number of hospital visits. A comparison of the two study arms.
Time frame
From date of randomization until the treatment is completed, assessed up to 2 months.4
Number of days hospitalized
Number of days hospitalized. A comparison of the two study arms.
Time frame
From date of randomization until the treatment is completed, assessed up to 2 months.Sponsors and contacts
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Source ClinicalTrials.gov