Computational Modeling of the Mature Unilateral Cleft Lip Nasal Deformity for Objective Assessment of Patient Nasal Function and Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Validation of computational fluid dynamics simulation with breathing measurement
研究概览
简要总结
The purpose of this study is to use computers to simulate airflow in 3D construction of your nasal cavity generated from cone beam CT images. The results from computer simulations will help researchers identify the severity of cleft-induced nasal dysfunction and assess the impact of current treatment in restoring breathing function. The ultimate goal is to improve post-surgery outcomes to restore nasal breathing function to normal levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Provide signed and dated informed consent form.
- •Willing to comply with all study procedures and be available for the duration of the study.
- •Male or female, aged ≥18 years of age.
- •Clinical diagnosis of unilateral cleft lip nasal deformity (uCLND)
- •Scheduled to undergo elective surgery for nasal obstruction
- •Scheduled to have a Cone Beam Computed Tomography (CBCT) as part of the pre- operative work-up for elective surgery.
排除标准
- •Prior cleft rhinoplasty or septoplasty for correction of nasal obstruction
- •Pregnant women: A pregnancy test will be performed within 48 hours of baseline
- •Patients unable or unwilling to comply with study procedures outlined in protocol
结局指标
主要结局
Validation of computational fluid dynamics simulation with breathing measurement
时间窗: 6 months
Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance from rhinomanometry breathing measurement
Effectiveness of current surgery in restoring nasal function based on volumetric airflow
时间窗: 6 months
Analysis of significant difference in volumetric airflow rate between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.
Validation of computational fluid dynamics simulation with in vitro experiment
时间窗: 6 months
Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance measurement from in vitro experiment of 3D printed plastic nasal replica
Effectiveness of current surgery in restoring nasal function based on nasal resistance
时间窗: 6 months
Analysis of significant difference in nasal resistance between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images
Effectiveness of current surgery in restoring nasal function based on nasal heat flux
时间窗: 6 months
Analysis of significant difference in nasal heat flux between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.
Effectiveness of current surgery in restoring nasal function based on nasal moisture flux
时间窗: 6 months
Analysis of significant difference in nasal moisture flux between pre-surgery and post-surgery data from computational fluid dynamics simulations of patient-specific 3D nasal models generated from cone-beam computed tomography images.
Anatomical sites of greatest nasal obstruction
时间窗: 6 months
Analysis on agreement of computational fluid dynamics identified anatomical sites of greatest nasal obstruction from pre-surgery 3D nasal models and actual surgical anatomical sites. CFD identified sites of greatest nasal obstruction are regions in the airway with highest nasal resistance.
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on volumetric airflow
时间窗: 6 months
Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computational fluid dynamics generated unilateral left and right side percent asymmetric will be computed used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal resistance
时间窗: 6 months
Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computed nasal resistance will be used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients
Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal heat flux
时间窗: 6 months
Creation of virtual surgery nasal airway models based on computational fluid dynamics identified anatomical sites of greatest nasal obstruction. Computed nasal moisture flux will be used to identify the top three virtual surgery nasal airway models with best treatment potentials for unilateral cleft lip nasal deformity patients
次要结局
- Change in patient-reported outcome (PRO) measures(baseline, 2 weeks, 8 weeks, 6 months, 12 months)
- in vitro analysis for top three virtual surgery nasal models with best treatment based on nasal pressure(6 months)
- in vitro analysis for top three virtual surgery nasal models with best treatment based on unilateral volumetric airflow(6 months)