Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163209
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-29
Brief Title:
Ultrasonography in the Diagnosis of Nasal Fractures
Sponsor:
Medical University of Gdansk
Organization:
Medical University of Gdansk
Study Overview
Official Title:
High-resolution Point of Care Ultrasonography in the Diagnosis of Nasal Fractures a 10-step Protocol
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 clinicians 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 KB6252023
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 eg rhinoplasty frontalethmoid sinus surgery or minor invasive procedures eg 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 Cohens 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
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 clinicians 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 KB6252023
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 eg rhinoplasty frontalethmoid sinus surgery or minor invasive procedures eg 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 Cohens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None