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

Nasal Obstruction Clinical Trial

Official title:

Computational Modeling of the Mature Unilateral Cleft Lip Nasal Deformity for Objective Assessment of Patient Nasal Function and Treatment Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04150783
• Other study ID #: Pro00102005
• Secondary ID: R01DE028554
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Amy Walker
• Phone: 919-684-17325
• Email: amy.walker1[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Nose
• Nasal Obstruction

Intervention

Procedure:
• Surgical repair for nasal obstruction
Patient reported quality of life questionnaires

Locations

Country	Name	City	State
United States	Duke University Medical Center and affiliated practices	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	6 months
Primary	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.	6 months
Primary	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	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	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	6 months
Primary	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	6 months
Primary	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	6 months
Secondary	Change in patient-reported outcome (PRO) measures	Change PRO measures as measured by NOSE questionnaire	baseline, 2 weeks, 8 weeks, 6 months, 12 months
Secondary	Change in patient-reported outcome (PRO) measures	Change PRO measures as measured by SCHNOS questionnaire	baseline, 2 weeks, 8 weeks, 6 months, 12 months
Secondary	Change in patient-reported outcome (PRO) measures	Change PRO measures as measured by CLEFT-Q questionnaire	baseline, 2 weeks, 8 weeks, 6 months, 12 months
Secondary	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.	6 months
Secondary	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.	6 months