Computational Modeling of Cleft Lip Nasal Deformity and Assessment of Nasal Function and Treatment Outcomes

Duke University12 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cleft Lip and Nose Nasal Obstruction

Interventions

Surgical repair for nasal obstructionPROCEDURE

Patient reported quality of life questionnaires

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

Duke University Medical Center and affiliated practices

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Validation of computational fluid dynamics simulation with breathing measurement

Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance from rhinomanometry breathing measurement

Time frame: 6 months

Validation of computational fluid dynamics simulation with in vitro experiment

Percent agreement between computational fluid dynamics simulated nasal resistance and nasal resistance measurement from in vitro experiment of 3D printed plastic nasal replica

Time frame: 6 months

Effectiveness of current surgery in restoring nasal function based on volumetric airflow

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.

Time frame: 6 months

Effectiveness of current surgery in restoring nasal function based on nasal resistance

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

Time frame: 6 months

Effectiveness of current surgery in restoring nasal function based on nasal heat flux

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.

Time frame: 6 months

Effectiveness of current surgery in restoring nasal function based on nasal moisture flux

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.

Data from ClinicalTrials.gov

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Time frame: 6 months

Anatomical sites of greatest nasal obstruction

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.

Time frame: 6 months

Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on volumetric airflow

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

Time frame: 6 months

Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal resistance

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

Time frame: 6 months

Computational fluid dynamics based optimized treatment options for unilateral cleft lip nasal deformity patients based on nasal heat flux

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

Time frame: 6 months

Secondary Outcomes

Change in patient-reported outcome (PRO) measures

Change PRO measures as measured by NOSE questionnaire

Time frame: baseline, 2 weeks, 8 weeks, 6 months, 12 months

Change in patient-reported outcome (PRO) measures

Change PRO measures as measured by SCHNOS questionnaire

Time frame: baseline, 2 weeks, 8 weeks, 6 months, 12 months

Change in patient-reported outcome (PRO) measures

Change PRO measures as measured by CLEFT-Q questionnaire

Time frame: 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

in vitro analysis from 3D printed plastic nasal replica of top three virtual surgery nasal models with best treatment potential will be done using unilateral airflow pressure.

Time frame: 6 months

in vitro analysis for top three virtual surgery nasal models with best treatment based on unilateral volumetric airflow

in vitro analysis from 3D printed plastic nasal replica of top three virtual surgery nasal models with best treatment potential will be done using unilateral volumetric airflow rate.

Time frame: 6 months