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

Recruiting

• Conditions: Nasal Obstruction; Cleft Lip and Nose
• Interventions: Procedure: Surgical repair for nasal obstruction

• Registration Number: NCT04150783
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-31
• Study Start: 2019-11-01
• Study First Posted: 2019-11-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unilateral Cleft Lip Nasal Deformity (uCLND)	Surgical repair for nasal obstruction	uCLND patients who are scheduled to undergo surgical treatment for nasal obstruction as standard of care.

Primary Outcome Measures

Name	Time	Method
Validation of computational fluid dynamics simulation with breathing measurement	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	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	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	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	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	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	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	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	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	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

Secondary Outcome Measures

Name	Time	Method
Change in patient-reported outcome (PRO) measures	baseline, 2 weeks, 8 weeks, 6 months, 12 months	Change PRO measures as measured by CLEFT-Q questionnaire
in vitro analysis for top three virtual surgery nasal models with best treatment based on nasal pressure	6 months	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.
in vitro analysis for top three virtual surgery nasal models with best treatment based on unilateral volumetric airflow	6 months	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.

Trial Locations

Locations (1)

Duke University Medical Center and affiliated practices; 🇺🇸 Durham, North Carolina, United States