Improving Outcomes in Pediatric Obstructive Sleep Apnea
This study aims to improve how doctors choose surgery for children aged 3 to 18 with obstructive sleep apnea (OSA). OSA is when breathing repeatedly stops and starts during sleep. While removing tonsils and adenoids is a common first step, it doesn't always work. This study uses a special type of MRI with inhaled 129-Xe (Xenon gas) to create computer models of a child's airway. These models will help predict which surgical option will be most successful in reducing OSA, measured by changes in their obstructive apnea-hypopnea index (oAHI) 90 days after surgery. The goal is to find a better way to decide on surgery for each child.
- Study design
- This interventional study plans to enroll 120 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants' surgical outcomes will be measured 90 days after surgery.
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Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Alister Bates, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
Who to contact
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What this trial measures
- Predict the surgical option with the most successful outcome with patient-specific validation computational fluid dynamics (CFD) airflow simulations of respiratory upper airways of children with DS and OSA using inhaled Xenon gas phase-contrast MRI.90 days
To solve the equations governing flow (the Navier-Stokes Equations), the airway model will be divided into 3-5 million cells using Star-CCM+ (Siemens PLM Software, Plano, TX). The inlet flow boundary condition for CFD simulations will be the respiratory flow rate as measured by an MRI-compatible pneumotach,83 which records flow rates synchronously with MRI. The flow solver (also Star-CCM+) will compute the pressure and velocity fields down to the resolution of the cells. The influence of flow features smaller than the cells will be calculated using the large eddy simulation (LES) turbulence model.46,69,84 The duration of the breath will be divided into time-steps lasting 0.1 ms, and the flow solution calculated for each timestep. In between each time-step, the airway model will be moved according to the results of the image registration.18 The result will be temporal and spatial maps of the air flow velocity and pressure throughout the breath.
- Measure changes in geometric analysis of airway, airway resistance, and pressure forces with surgical outcome as measured by changes in oAHI (obstructive apnea-hypopnea index)90 days
Surgical interventions aimed at reducing the oAHI in patients with persistent OSA post-T\&A have variable success rates. Airway obstruction in each child can be characterized by geometric analysis of the airway, airway resistance, pressure forces, and the cause of airway collapse (either due to air pressure forces or neuromuscular control). Comparing the changes in these characteristics with the actual surgical outcome, measured by change in the oAHI, will reveal which characteristics determine surgical success.