Nasal Bone FractureNCT06163209
Ultrasonography in the Diagnosis of Nasal Fractures
An observational study of Nasal Bone Fracture and Nasal Injury, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Bone Fracture, Nasal Injury, Facial Injuries
- What is being tested?
- Nasal Ultrasonography and Computed Tomography Scan of the Face
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 8 Dec 2023to 1 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- nasal trauma during the 14 days preceding examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdańsk
Gdansk, Pomeranian Voivodeship, 80-210
Grzegorz Śmigielski, M.D., +48660614536, grsmigielski@gumed.edu.pl
Boguslaw Mikaszewski, Ph.D., +48602358012, boguslaw.mikaszewski@gumed.pl
About this study
Official title: 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.
Read the 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.
- Conditions
- Nasal Bone Fracture, Nasal Injury, Facial Injuries, Nasal Deformity, Acquired, Nose; Wound
- Being tested
- Nasal Ultrasonography, Computed Tomography Scan of the Face
- Keywords
- high-resolution ultrasonography, point-of-care ultrasonography, nasal fracture
- Medical subject headings
- Facial Injuries, Nose Deformities, Acquired, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal UltrasonographyDiagnostic test
Also called High resolution 10-point ultrasonography of the external 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 following protocol:
- Sagittal plane, along the most prominent part of nasal dorsum.
- Transverse plane, level of nasion.
- Transverse plane, level of intercanthal line.
- Transverse plane, level of rhinion.
- Along inferior border of the right nasal bone.
- Along inferior border of the left nasal bone.
- Along medial part of the right orbital rim below frontomaxillary suture.
- Along medial part of the right orbital rim below frontomaxillary suture.
- Along the line connecting right frontomaxillary suture and the tip of the nose.
- 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.
Computed Tomography Scan of the FaceDiagnostic test
Also called A computed tomography covering the whole facial skeleton and a skull base.
A standard computed tomography scan of the face will be performed and the following areas will be assessed by an experienced radiologist:
- Bony part of the nasal septum
- Left nasal bone - part proximal to the intercanthal line
- Right nasal bone - part proximal to the intercanthal line
- Left nasal bone - part distal to the intercanthal line
- Right nasal bone - part distal to the intercanthal line
- Frontal process of the left maxilla
- Frontal process of the right maxilla
| Study group | Role | What they receive |
|---|---|---|
| Suspected nasal fracture | Patients with a history of recent nasal trauma. Receives: Diagnostic Test: Nasal Ultrasonography; Diagnostic Test: Computed Tomography Scan of the Face |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Ultrasonography: a 10-step protocol.
Images obtained at each location will be assessed for the following five findings:
- isolated bone discontinuity
- misalignment of the bone surface without displaced fracture edges
- misalignment of the bone surface with displaced fracture edges
- dislocated minor bone fragment (largest dimension under 2 mm)
- 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).
Measured: Each participant will be assessed once, within 14 days of the nasal trauma.
Secondary outcomes (2)
Computed Tomography of the Face
Each of 7 anatomical areas will be assessed for one of two findings:
- non-displaced fracture
- displaced fracture
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).
Measured: Each participant will be assessed once, within 14 days of the nasal trauma.
Clinical features
Following clinical data associated with present nasal trauma will be collected and entered into the database as variables:
- time period since the injury
- epistaxis
- nasal obstruction
- crepitus or palpable mobility of bone fragments
- swelling of the nasal pyramid
- nasal pyramid asymmetry - absent before trauma
- septal deviation - absent before trauma
- fracture reposition attempt
- improvement after reposition
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.
Measured: Each participant will be assessed once, within 14 days of the nasal trauma.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start8 Dec 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nasal Bone FractureStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grzegorz Śmigielski, Medical University of Gdansk
- Investigators
- Grzegorz Śmigielski, M.D., Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163209
- Sponsor's protocol ID
- NFUS2023
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
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.
PubMed 33009831Astaraki 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.
PubMed 35734733Shigemura 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.
PubMed 28607870Westfall 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.
PubMed 31526629Hwang 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.
PubMed 30450348Caglar 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.
PubMed 28552270Lee 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.
PubMed 25749616Hoffmann 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.
PubMed 26126215Gossner 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.
PubMed 25368692Jecker 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.
PubMed 16453210
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution Point of Care Ultrasonography in the Diagnosis of Nasal Fractures: a 10-step Protocol
- ClinicalTrials.gov ID
- NCT06163209
- Acronym / sponsor ID
- NFUS2023
- Conditions
- Nasal Bone Fracture, Nasal Injury, Facial Injuries, Nasal Deformity, Acquired, Nose; Wound
- Keywords
- high-resolution ultrasonography, point-of-care ultrasonography, nasal fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected nasal fracture | – | Diagnostic Test: Nasal Ultrasonography, Diagnostic Test: Computed Tomography Scan of the FacePatients with a history of recent nasal trauma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- nasal trauma during the 14 days preceding examination
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal UltrasonographyAlso: High resolution 10-point ultrasonography of the external 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 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 | Suspected nasal fracture |
| Computed Tomography Scan of the FaceAlso: A computed tomography covering the whole facial skeleton and a skull base.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 | Diagnostic test | Suspected nasal fracture |
Primary outcome
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: 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).
2 secondary outcomes
Computed Tomography of the Face
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 33009831Gokcen 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.
- Background: PubMed 35734733Astaraki 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.
- Background: PubMed 28607870Shigemura 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.
- Background: PubMed 31526629Westfall 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.
- Background: PubMed 30450348Hwang 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.
- Background: PubMed 28552270Caglar 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.
- Background: PubMed 25749616Lee 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.
- Background: PubMed 26126215Hoffmann 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.
- Background: PubMed 25368692Gossner 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.
- Background: PubMed 16453210Jecker 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grzegorz Śmigielski, M.D. principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Bone Fracture and Nasal Injury, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grzegorz Śmigielski, M.D. (+48 660 614 536, g.smigielski@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Ultrasonography: a 10-step protocol. (time frame: Each participant will be assessed once, within 14 days of the nasal trauma.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06163209, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.