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Ultrasonography in the Diagnosis of Nasal Fractures

NCT06163209 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2023-12-11

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Nasal Ultrasonography

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.

DIAGNOSTIC_TEST

Computed Tomography Scan of the Face

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

Sponsors & Collaborators

  • Medical University of Gdansk

    lead OTHER

Principal Investigators

  • Grzegorz Śmigielski, M.D. · Medical University of Gdansk

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-08
Primary Completion
2024-12-01
Completion
2025-12-01
FDA Device
Yes

Countries

  • Poland

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 NCT06163209 on ClinicalTrials.gov