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

NCT03824288 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2019-08-20

No results posted yet for this study

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)

Conditions

  • Peritonsillar Abscess

Interventions

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.

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Tobias Todsen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2019-08-30
Completion
2020-04-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03824288 on ClinicalTrials.gov