- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06163209
Ultrasonography in the Diagnosis of Nasal Fractures
High-resolution Point of Care Ultrasonography in the Diagnosis of Nasal Fractures: a 10-step Protocol
The purpose of this cross-sectional prospective observational study is to determine the efficacy of high-resolution ultrasonography in identifying and characterizing nasal bone fractures in adult patients with recent facial trauma. The primary questions it aims to answer are:
- Can high-resolution ultrasonography effectively detect nasal bone fractures?
- Is high-resolution ultrasonography capable of indirectly detecting septal fractures?
- What are the specificity and sensitivity of high-resolution ultrasonography in comparison to computed tomography scan?
Participants will undergo examination and treatment in accordance with current standards for nasal fracture management. Additionally, high-resolution ultrasonography will be performed during the initial physical examination, preceding any therapeutic interventions.
Study Overview
Status
Intervention / Treatment
Detailed Description
BACKGROUND
The bony and cartilaginous skeleton of the external nose is exceptionally prone to injury, due to its fragile structure and protruding, tent-like shape. As the cartilages are able to bend under pressure, the impact of trauma is usually transferred to the thinnest, distal parts of nasal bones, where they overlap the lateral cartilages forming a junction called the keystone region. This location plays a major role in supporting the cartilaginous skeleton and, at the same time, is most likely to be fractured. Similarly, the cartilaginous nasal septum is able to bend, which is the reason why trauma to the distal nasal bones frequently continues along anterior borders of the perpendicular plate of the ethmoid and vomer, creating a complex, C-shaped septal fracture. These pathomechanisms of nasal fracture explain its possible significant negative influence on the function and aesthetics of the nose. Early nasal fracture detection and treatment is critical for avoiding complications. Clinical examination is considered a gold standard for the diagnosis. Imaging tests are of secondary importance, as their clinical application in this condition has many disadvantages. A commonly applied plain radiograph of the nose was proven not to be cost efficient due to high percentage of false results. A computed tomography scan (CT) has a satisfactory sensitivity and specificity, but is relatively expensive, causes radiation exposure and provides images of limited resolution, which may fail to reveal subtle fracture lines.
Several studies have shown high-resolution ultrasonography (HRUS) to be a safe and efficient method for nasal fracture diagnosis. However, the use of this modality in a clinical setup has not become common, despite over 20-year history of publications supporting its efficacy. Potential factors contributing to this circumstance include a lack of a standardized examination protocol, a difficult ultrasonography image acquisition and a clinician's reluctance to use a full-sized device in an otolaryngology medical office.
The aim of this study is to assess the efficacy of a standardized 10-step point-of-care ultrasonography in the diagnosis of nasal fractures.
STUDY DESIGN
This cross-sectional prospective study will be conducted between December 1, 2023, and December 1, 2024, at the University Clinical Centre in Gdańsk, in accordance with the Helsinki Declaration and with approval from the institutional bioethics committee for scientific research (No: KB/625/2023).
Patients who have presented to the emergency department with nasal trauma sustained within the 14 days preceding their consultation will be enrolled in the study. Exclusion criteria will include extensive facial trauma, a history of nasal fracture, surgical interventions (e.g. rhinoplasty, frontal/ethmoid sinus surgery), or minor invasive procedures (e.g. hyaluronic acid filler, thread lifting) in the examined area.
A CT scan of the face and HRUS protocol will be performed before any interventions are undertaken.
A total of 50 patients is anticipated.
The collected data will include medical history, physical examination, CT scan of the face and HRUS of the nose.
Ultrasonography of the external nose will be performed with the use of a high-resolution transducer (Clarius L20HD3 8-20 MHz) and a 3mm-thick disposable gel pad, according to the 10-step protocol. At each location, the transducer position will be adjusted with rocking and tilting movements until it is held perpendicular to the bone surface, which provides optimal image quality, and a single image will be saved for further assessment. Images obtained at each location will be assessed for five different findings.
A standard computed tomography scan of the face will be performed. Each of 7 specific areas will be assessed by an experienced radiologist for a diclocated or non-dislocated nasal fracture.
DATA ANALYSIS
Statistical analysis of the data will be performed using the R language. A variable marked as a "final diagnosis established by the consulting clinician" will be considered a reference point for calculating the sensitivity and specificity of methods. For this purpose, a McNeymar chi-square test and Cohen's Kappa will be used.
Records lacking the final diagnosis or any part of the HRUS protocol will be excluded from the study.
The database will be anonymised.
The source data and the database verification will be performed collectively by the authors following the addition of every 10 new records.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Grzegorz Śmigielski, M.D.
- Phone Number: +48 660 614 536
- Email: g.smigielski@gumed.edu.pl
Study Contact Backup
- Name: Bogusław Mikaszewski, Ph.D.
- Phone Number: +48583493111
- Email: boguslaw.mikaszewski@gumed.edu.pl
Study Locations
-
-
Pomorskie
-
Gdańsk, Pomorskie, Poland, 80-210
- Recruiting
- Medical University of Gdansk
-
Contact:
- Grzegorz Śmigielski, M.D.
- Phone Number: +48660614536
- Email: grsmigielski@gumed.edu.pl
-
Contact:
- Boguslaw Mikaszewski, Ph.D.
- Phone Number: +48602358012
- Email: boguslaw.mikaszewski@gumed.pl
-
Sub-Investigator:
- Karolina Markiet, Ph.D.
-
Sub-Investigator:
- Bogusław Mikaszewski, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- nasal trauma during the 14 days preceding examination
Exclusion Criteria:
- extensive facial injuries
- history of surgical or non-surgical interventions in the examined area
- history of nasal fracture
- refusal to participate, inability to give consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Suspected nasal fracture
Patients with a history of recent nasal trauma.
|
Ultrasonography of the external nose will be performed with the use of a high-resolution transducer (Clarius L20HD3 8-20 MHz) and a 3mm-thick disposable gel pad, according to the following protocol:
At each location the transducer position will be adjusted until it is held perpendicular to the bone surface and a single image will be saved for further assessment.
Other Names:
A standard computed tomography scan of the face will be performed and the following areas will be assessed by an experienced radiologist:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nasal Ultrasonography: a 10-step protocol.
Time Frame: Each participant will be assessed once, within 14 days of the nasal trauma.
|
Images obtained at each location will be assessed for the following five findings:
There will be 50 variables in total, marked as a combination of location (number 1-10) and finding (a-e) e.g. 1a, 1b, 1c, 1d, 1e, 2a, 2b, 2c ,2d. Variables will be dichotomous, with possible values of P (positive), N (negative) and N/A (not to be assessed). |
Each participant will be assessed once, within 14 days of the nasal trauma.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Computed Tomography of the Face
Time Frame: Each participant will be assessed once, within 14 days of the nasal trauma.
|
Each of 7 anatomical areas will be assessed for one of two findings:
There will be 14 variables in total, marked as a combination of location (number 1-7) and finding (a-b) e.g. 1a, 1b, 2a, 2b, 3a, 3b. Variables will be dichotomous, with possible values of P (positive), N (negative) and N/A (not to be assessed). |
Each participant will be assessed once, within 14 days of the nasal trauma.
|
Clinical features
Time Frame: Each participant will be assessed once, within 14 days of the nasal trauma.
|
Following clinical data associated with present nasal trauma will be collected and entered into the database as variables:
Variables will be dichotomous, with possible values of P (positive), N (negative) and N/A (not to be assessed), except for time period, which will be a number in the range from 0 to 14. |
Each participant will be assessed once, within 14 days of the nasal trauma.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Grzegorz Śmigielski, M.D., Medical University of Gdansk
Publications and helpful links
General Publications
- Gokcen E, Savrun A, Kusdogan M, Caltekin I, Albayrak L, Atik D, Vural S, Savrun ST, Yildirim G. Ability of Bedside Ultrasonography to Detect Pediatric Nasal Bone Fractures. Laryngoscope. 2021 Jun;131(6):1398-1403. doi: 10.1002/lary.29168. Epub 2020 Oct 3.
- Astaraki P, Baghchi B, Ahadi M. Diagnosis of acute nasal fractures using ultrasound and CT scan. Ann Med Surg (Lond). 2022 May 26;78:103860. doi: 10.1016/j.amsu.2022.103860. eCollection 2022 Jun.
- Shigemura Y, Ueda K, Akamatsu J, Sugita N, Nuri T, Otsuki Y. Ultrasonographic Images of Nasal Bone Fractures with Water Used as the Coupling Medium. Plast Reconstr Surg Glob Open. 2017 May 30;5(5):e1350. doi: 10.1097/GOX.0000000000001350. eCollection 2017 May.
- Westfall E, Nelson B, Vernon D, Saltagi MZ, Mantravadi AV, Schmalbach C, Ting JY, Shipchandler TZ. Nasal bone fractures and the use of radiographic imaging: An otolaryngologist perspective. Am J Otolaryngol. 2019 Nov-Dec;40(6):102295. doi: 10.1016/j.amjoto.2019.102295. Epub 2019 Sep 9.
- Hwang K, Jung JS, Kim H. Diagnostic Performance of Plain Film, Ultrasonography, and Computed Tomography in Nasal Bone Fractures: A Systematic Review. Plast Surg (Oakv). 2018 Nov;26(4):286-292. doi: 10.1177/2292550317749535. Epub 2018 Jan 9.
- Caglar B, Serin S, Akay S, Yilmaz G, Torun A, Adibelli ZH, Parlak I. The accuracy of bedside USG in the diagnosis of nasal fractures. Am J Emerg Med. 2017 Nov;35(11):1653-1656. doi: 10.1016/j.ajem.2017.05.015. Epub 2017 May 18.
- Lee IS, Lee JH, Woo CK, Kim HJ, Sol YL, Song JW, Cho KS. Ultrasonography in the diagnosis of nasal bone fractures: a comparison with conventional radiography and computed tomography. Eur Arch Otorhinolaryngol. 2016 Feb;273(2):413-8. doi: 10.1007/s00405-015-3595-8. Epub 2015 Mar 8.
- Hoffmann JF. An Algorithm for the Initial Management of Nasal Trauma. Facial Plast Surg. 2015 Jun;31(3):183-93. doi: 10.1055/s-0035-1555618. Epub 2015 Jun 30.
- Gossner J. Sonography of the nasal cartilage: technique and normal anatomy. J Ultrasound. 2014 Aug 5;17(4):317-9. doi: 10.1007/s40477-014-0123-4. eCollection 2014 Dec.
- Jecker P. [Diagnostic use of ultrasound for examination of the nose and the paranasal sinuses]. Ultraschall Med. 2005 Dec;26(6):501-6. doi: 10.1055/s-2005-857898. German.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NFUS2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Protocol and Statistical Analysis Plan will be shared upon request, including individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Proposals should be directed to "g.smigielski@gumed.edu.pl". To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Facial Injuries
-
University of UtahCompletedSynkinesis | Facial Asymmetry | Facial Nerve Injuries | Facial Paresis Associated With Facial Nerve Dysfunction
-
Johns Hopkins UniversityRecruitingFacial Injuries | Facial Deformity | Craniofacial Defects | Craniofacial Injuries | Traumatic Wounds and Injuries | Facial TransplantationUnited States
-
Massachusetts General HospitalNot yet recruitingFacial Injuries | Facial Deformity | Facial Trauma
-
NYU Langone HealthRecruitingFacial Injuries | Hand Injuries | Facial Deformity | Craniofacial Injuries | Upper Extremity Injuries | Face InjuriesUnited States
-
University of MichiganRecruitingFacial DefectUnited States
-
University of Texas at AustinCompletedFacial LacerationUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...UnknownInjury of Facial Nerve, Unspecified Side, Initial Encounter
-
David Grant U.S. Air Force Medical CenterWithdrawnFacial Injuries and Disorders
-
University of PittsburghUnited States Department of DefenseCompletedFacial Injuries | Adipose TissueUnited States
-
Children's Hospitals and Clinics of MinnesotaWithdrawnFacial and Scalp LacerationsUnited States
Clinical Trials on Nasal Ultrasonography
-
Baskent University Ankara HospitalBatman Maternity HospitalCompleted
-
Benha UniversityUnknownPostmenopausal BleedingEgypt
-
Ankara City Hospital BilkentNot yet recruitingObstructive Sleep Apnea | Respiratory Complication | Airway Edema
-
Waldfriede HospitalRecruiting
-
Cantonal Hosptal, BasellandInsel Gruppe AG, University Hospital BernRecruitingObstructive Sleep Apnea | Sleep-Disordered BreathingSwitzerland
-
Cairo UniversityRecruitingHypertension in PregnancyEgypt
-
Sohag UniversityNot yet recruitingHepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients
-
Assiut UniversityNot yet recruitingPlacenta Previa | Vaginal Bleeding | Antepartum Hemorrhage
-
Assiut UniversityNot yet recruitingPediatric Lymphoma
-
Zeynep Kamil Maternity and Pediatric Research and...RecruitingEndometriosis, Rectum | ULTRASONOGRAPHYTurkey