Ultrasonography in the Diagnosis of Nasal Fractures

NCT06163209 | Unknown FDA Device

• 1 other identifier: NFUS2023
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasal Bone Fracture; Nasal Injury; Facial Injuries; Nasal Deformity, Acquired; Nose; Wound

Keywords

high-resolution ultrasonography; point-of-care ultrasonography; nasal fracture

Outcome Measures

Primary Outcomes (1)

• Nasal Ultrasonography: a 10-step protocol.

  Images obtained at each location will be assessed for the following five findings: 1. isolated bone discontinuity 2. misalignment of the bone surface without displaced fracture edges 3. misalignment of the bone surface with displaced fracture edges 4. dislocated minor bone fragment (largest dimension under 2 mm) 5. soft tissue haematoma 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 Outcomes (2)

• Computed Tomography of the Face

  Each participant will be assessed once, within 14 days of the nasal trauma.

• Clinical features

  Each participant will be assessed once, within 14 days of the nasal trauma.

Study Arms (1)

Suspected nasal fracture

Patients with a history of recent nasal trauma.

Diagnostic Test: Nasal Ultrasonography; Diagnostic Test: Computed Tomography Scan of the Face

Interventions

Nasal Ultrasonography DIAGNOSTIC_TEST

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: 1. Sagittal plane, along the most prominent part of nasal dorsum. 2. Transverse plane, level of nasion. 3. Transverse plane, level of intercanthal line. 4. Transverse plane, level of rhinion. 5. Along inferior border of the right nasal bone. 6. Along inferior border of the left nasal bone. 7. Along medial part of the right orbital rim below frontomaxillary suture. 8. Along medial part of the right orbital rim below frontomaxillary suture. 9. Along the line connecting right frontomaxillary suture and the tip of the nose. 10. Along the line connecting left frontomaxillary suture and the tip of the nose. 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.

Also known as: High resolution 10-point ultrasonography of the external nose.

Suspected nasal fracture

Computed Tomography Scan of the Face DIAGNOSTIC_TEST

A standard computed tomography scan of the face will be performed and the following areas will be assessed by an experienced radiologist: 1. Bony part of the nasal septum 2. Left nasal bone - part proximal to the intercanthal line 3. Right nasal bone - part proximal to the intercanthal line 4. Left nasal bone - part distal to the intercanthal line 5. Right nasal bone - part distal to the intercanthal line 6. Frontal process of the left maxilla 7. Frontal process of the right maxilla

Also known as: A computed tomography covering the whole facial skeleton and a skull base.

Suspected nasal fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a history of recent facial trauma involving external nose. Patients with no history of surgical or non-surgical interventions in the examined area eg. rhinoplasty, hyaluronic acid filler, external approach frontal/ethmoid sinus surgery as well as no history of nasal fracture.

You may qualify if:

• nasal trauma during the 14 days preceding examination

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, 80-210, Poland

RECRUITING

Related Publications (10)

• 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.

  PMID: 33009831 BACKGROUND

• 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.

  PMID: 35734733 BACKGROUND

• 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.

  PMID: 28607870 BACKGROUND

• 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.

  PMID: 31526629 BACKGROUND

• 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.

  PMID: 30450348 BACKGROUND

• 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.

  PMID: 28552270 BACKGROUND

• 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.

  PMID: 25749616 BACKGROUND

• 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.

  PMID: 26126215 BACKGROUND

• 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.

  PMID: 25368692 BACKGROUND

• 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.

  PMID: 16453210 BACKGROUND

MeSH Terms

Conditions

Facial Injuries; Nose Deformities, Acquired; Wounds and Injuries

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Grzegorz Śmigielski, M.D.

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grzegorz Śmigielski, M.D.

CONTACT

+48 660 614 536; g.smigielski@gumed.edu.pl

Bogusław Mikaszewski, Ph.D.

CONTACT

+48583493111; boguslaw.mikaszewski@gumed.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 8, 2023
• Study Start: December 8, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• Access Criteria: For individual participant data meta-analysis. Proposed use of the data should have been approved by an independent review committee.

Locations

PL (1)