High-resolution Point of Care Ultrasonography in the Diagnosis of Nasal Fractures: a 10-step Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Nasal Ultrasonography: a 10-step protocol.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •nasal trauma during the 14 days preceding examination
排除标准
- •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
结局指标
主要结局
Nasal Ultrasonography: a 10-step protocol.
时间窗: 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).
次要结局
- 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.)
研究者
Grzegorz Śmigielski
Principal Investigator
Medical University of Gdansk