Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04991389
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2021-04-09
Brief Title:
Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSA-MRI
Brief Summary:
To create a validated computational tool to predict surgical outcomes for pediatric patients with obstructive sleep apnea OSA The first line of treatment for children with OSA is to remove their tonsils and adenoids however these surgeries do not always cure the patient Another treatment continuous positive airway pressure CPAP is only tolerated by 50 of children Therefore many children undergo surgical interventions aimed at soft tissue structures surrounding the airway such as tonsils tongue and soft palate andor the bony structures of the face However the success rates of these surgeries is surprisingly low Therefore there a need for a tool to improve the efficacy and predict which surgical option is going to benefit each individual patient most effectively Computational fluid dynamics CFD simulations of respiratory airflow in the upper airways can provide this predictive tool allowing the effects of various surgical options to be compared virtually and the option most likely to improve the patients condition to be chosen Previous CFD simulations have been unable to provide information about OSA as they were based on rigid geometries or did not include neuromuscular motion a key component in OSA This project uses real-time magnetic resonance imaging MRI to provide the anatomy and motion of the airway to the CFD simulation meaning that the exact in vivo motion is modeled for the first time Furthermore since the modeling is based on MRI a modality which does not use ionizing radiation it is suitable for longitudinal assessment of patients before and after surgical procedures In vivo validation of these models will be achieved for the first time through comparison of CFD-based airflow velocity fields with those generated by phase-contrast MRI of inhaled hyperpolarized 129Xe gas This research is based on data obtained from sleep MRIs achieved with the subject under sedation While sedating the patient post-operatively is slightly more than minimal risk the potential benefits to each patient outweigh this risk As 58 of patients have persistent OSA postsurgery and the average trajectory of OSA severity is an increase over time post-operative imaging and modeling can benefit the patient by identifying the changes to the airway made during surgery and which anatomy should be targeted in future treatments
Detailed Description:
This project aims to create a validated computational tool to predict surgical outcomes for pediatric patients with obstructive sleep apnea OSA The first line of treatment for children with OSA is to remove their tonsils and adenoids however these surgeries do not always cure the patient Another treatment continuous positive airway pressure CPAP is only tolerated by 50 of children Therefore many children undergo surgical interventions aimed at soft tissue structures surrounding the airway such as tonsils tongue and soft palate andor the bony structures of the face However the success rates of these surgeries measured as a reduction in the obstructive apnea-hypopnea index obstructive events per hour of sleep is surprisingly low Therefore there is a clear need for a tool to improve the efficacy of these surgeries and predict which of the various surgical options is going to benefit each individual patient most effectively Computational fluid dynamics CFD simulations of respiratory airflow in the upper airways can provide this predictive tool allowing the effects of various surgical options to be compared virtually and the option most likely to improve the patients condition to be chosen Previous CFD simulations have been unable to provide information about OSA as they were based on rigid geometries or did not include neuromuscular motion a key component in OSA This project uses real-time magnetic resonance imaging MRI to provide the anatomy and motion of the airway to the CFD simulation meaning that the exact in vivo motion is modeled for the first time Furthermore since the modeling is based on MRI a modality which does not use ionizing radiation it is suitable for longitudinal assessment of patients before and after surgical procedures In vivo validation of these models will be achieved for the first time through comparison of CFD-based airflow velocity fields with those generated by phase-contrast MRI of inhaled hyperpolarized 129Xe gas This research is based on data obtained from sleep MRIs achieved with the subject under sedation While sedating the patient post-operatively is slightly more than minimal risk the potential benefits to each patient outweigh this risk As 58 of patients have persistent OSA postsurgery and the average trajectory of OSA severity is an increase over time post-operative imaging and modeling can benefit the patient by identifying the changes to the airway made during surgery and which anatomy should be targeted in future treatments
Pediatric obstructive sleep apnea OSA is a sleep-related breathing disorder characterized by upper airway obstruction This disorder affects 22 million children in the US alone1 If untreated OSA can result in behavioral cognitive metabolic and cardiovascular morbidities23 Although adenotonsillectomy TA is the first-line treatment a large percentage of children have persistent OSA after TA4-11 Continuous positive airway pressure CPAP is generally the second-line treatment12 however children have a compliance rate of only 5013 Children with persistent OSA who are noncompliant with CPAP often undergo surgery targeting soft tissue andor bony structures surrounding the upper airway with success rates ranging from 17 to 7214-17 The investigators preliminary data shows that 58 of patients who underwent soft tissue surgery post-TA had persistent moderate or severe OSA after the subsequent surgery The goal of this study is therefore to provide a predictive model that determines which post-TA surgical procedure is most likely to be effective in each individual surgical candidate This goal will be achieved through patient-specific computational fluid dynamics CFD models of airflow and upper airway collapse in these children Novel CFD models of OSA that uniquely incorporate airway motion derived from 3 dimensional 3D dynamic magnetic resonance imaging MRI obtained synchronously with airflow measurement were developed1819 Clinicians currently have no method of determining the contribution of neuromuscular control and air pressure forces in causing airway collapse or determining if the resistance to airflow in one portion of the upper airway induces collapse at another portion of the airway Patient-specific CFD can provide this information and thereby become an invaluable tool in assisting clinicians in choosing the surgical procedure that is most likely to optimize outcomes
The overall hypothesis is that the application of novel CFD models will produce a validated approach to accurately predict the surgical option with the most successful outcome This hypothesis will be tested by 1 validating CFD for surgical planning 2 identifying anatomic and aerodynamic factors eg changes in local resistance and flow-induced pressure forces due to post surgical changes in anatomy that determine surgical outcomes and 3 developing a virtual surgery platform to identify patient-specific surgical procedures that will lead to successful outcomes
Pediatric obstructive sleep apnea OSA is a sleep-related breathing disorder characterized by upper airway obstruction This disorder affects 22 million children in the US alone1 If untreated OSA can result in behavioral cognitive metabolic and cardiovascular morbidities23 Although adenotonsillectomy TA is the first-line treatment a large percentage of children have persistent OSA after TA4-11 Continuous positive airway pressure CPAP is generally the second-line treatment12 however children have a compliance rate of only 5013 Children with persistent OSA who are noncompliant with CPAP often undergo surgery targeting soft tissue andor bony structures surrounding the upper airway with success rates ranging from 17 to 7214-17 The investigators preliminary data shows that 58 of patients who underwent soft tissue surgery post-TA had persistent moderate or severe OSA after the subsequent surgery The goal of this study is therefore to provide a predictive model that determines which post-TA surgical procedure is most likely to be effective in each individual surgical candidate This goal will be achieved through patient-specific computational fluid dynamics CFD models of airflow and upper airway collapse in these children Novel CFD models of OSA that uniquely incorporate airway motion derived from 3 dimensional 3D dynamic magnetic resonance imaging MRI obtained synchronously with airflow measurement were developed1819 Clinicians currently have no method of determining the contribution of neuromuscular control and air pressure forces in causing airway collapse or determining if the resistance to airflow in one portion of the upper airway induces collapse at another portion of the airway Patient-specific CFD can provide this information and thereby become an invaluable tool in assisting clinicians in choosing the surgical procedure that is most likely to optimize outcomes
The overall hypothesis is that the application of novel CFD models will produce a validated approach to accurately predict the surgical option with the most successful outcome This hypothesis will be tested by 1 validating CFD for surgical planning 2 identifying anatomic and aerodynamic factors eg changes in local resistance and flow-induced pressure forces due to post surgical changes in anatomy that determine surgical outcomes and 3 developing a virtual surgery platform to identify patient-specific surgical procedures that will lead to successful outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None