Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT
Primary Purpose
Peritonsillar Abscess
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intraoral ultrasound
The landmark technique
Sponsored by
About this trial
This is an interventional diagnostic trial for Peritonsillar Abscess
Eligibility Criteria
Inclusion criteria:
- Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar abscess
Clinical findings of peritonsillar abscess by one of the following:
- Trismus
- Unilateral tonsillar/peritonsillar swelling
Exclusion criteria:
- Compromised airways or suspected retro / parapharyngeal abscess
- Needle aspiration of pus already performed (or participated in the study once earlier)
- Cannot understand the written information
Sites / Locations
- RigshospitaletRecruiting
- Odense University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
The landmark technique
Ultrasound-guided aspiration
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
needle aspirations
total number of needle aspirations performed
proportion of succesfull needle aspirations
proportion of needle aspirations with aspiration of pus
days on sick leave
Total number of days on sick leave after first intervention
Secondary Outcome Measures
Number of hospitalization days
Number of quincy tonsillectomies
Number of visits in outpatient clinic
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).
Full Information
NCT ID
NCT03824288
First Posted
January 23, 2019
Last Updated
August 19, 2019
Sponsor
Tobias Todsen
Collaborators
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03824288
Brief Title
Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT
Official Title
A Randomized Multicenter Trial of Ultrasound-Guided Aspiration of Peritonsillar Abscess Versus Conventional Landmark Technique
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tobias Todsen
Collaborators
Odense University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonsillar Abscess
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The landmark technique
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ultrasound-guided aspiration
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Intraoral ultrasound
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
The landmark technique
Intervention Description
A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted.
Primary Outcome Measure Information:
Title
needle aspirations
Description
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.
Title
proportion of succesfull needle aspirations
Description
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.
Title
days on sick leave
Description
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
Number of visits in outpatient clinic
Time Frame
Until full recovery from peritonsilar infection
Title
Patient-reported outcome
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar abscess
Clinical findings of peritonsillar abscess by one of the following:
Trismus
Unilateral tonsillar/peritonsillar swelling
Exclusion criteria:
Compromised airways or suspected retro / parapharyngeal abscess
Needle aspiration of pus already performed (or participated in the study once earlier)
Cannot understand the written information
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Todsen, MD, PhD
Phone
51847468
Email
tobias.todsen@regionh.dk
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Copenhagen East
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Todsen, MD, PhD
Facility Name
Odense University Hospital
City
Odense
State/Province
Odense C
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanne H Michaelsen, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
31686648
Citation
Todsen T, Stage MG, Michaelsen SH, Tolsgaard MG, Melchiors J, Madsen AR, Hahn CH, Godballe C. Protocol for a randomised clinical trial of transoral ultrasound versus standard of care in the diagnosis of peritonsillar abscess. Dan Med J. 2019 Nov;66(11):A5573.
Results Reference
derived
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Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT
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