Clinical Research Directory

Comparison of Dynamic Compliance and Airway Resistance in Pressure-Controlled Versus Volume-Controlled Ventilation in Children Undergoing Corrective Heart Surgery

The goal of this clinical trial was to compare two settings on a breathing machine used during heart surgery in children. The children in this study were born with a hole inside the heart. The hole lets extra blood flow to the lungs. Over time this can make the lungs stiffer and harder to inflate. All the children had surgery to close the hole, using a heart-lung machine. During surgery, a machine breathes for the child. It can be set in two ways. One way controls the pressure of each breath. The other way controls the amount of air in each breath. The main questions it aimed to answer were: Which setting kept the lungs easier to inflate during and after surgery? Which setting made it easier for air to move through the breathing tubes? Researchers compared children who got pressure-controlled ventilation with children who got volume-controlled ventilation, to see if lung function differed between the two groups. Participants: Had surgery to close the hole in the heart Got one of the two breathing machine settings, chosen at random Had lung measurements taken at eight points, from just after the breathing tube was placed until they were ready to come off the machine.

Prospective and Non-randomized Registry of CardioCel 3D

Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of care. The Registry will collect data with a minimum of 50 subjects per major indication (minimum total of 200) in 5-10 sites in Europe. The clinical investigation will maintain data for each patient from the date of implant through 2 years post-implantation.