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.
Age range
1 Month – 18 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Airway resistance
Timeframe: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation
Dynamic compliance
Timeframe: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation
PaO2/FiO2 ratio
Timeframe: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation