A randomised controlled trial to compare normoxic versus standard cardiopulmonary bypass in cyanotic children undergoing cardiac surgery
Sponsor: University Hospitals Bristol
REC Number: 01/H0106/172
Children with congenital heart disease often have lower than normal levels of oxygen in the blood (cyanosis) and need heart surgery to increase oxygen levels to normal. Cyanotic children who undergo this type of surgery are put on a heart-lung bypass machine, which pumps blood around the body while the heart is being operated on and allows surgical staff to decide how much oxygen the child gets during surgery.
Currently, cyanotic children are given 100% oxygen throughout their surgery, but there is evidence that this practice may damage the heart and other organs. This may be caused by introducing 100% oxygen at the beginning of surgery when the child’s body is not used to it.
The Oxic2 study aims to find out whether it is better to give lower levels of oxygen at the start of the operation. Children who participate in the study are allocated by chance to receive either the higher level of oxygen (100%) or lower levels of oxygen at the start of the operation (similar to what a child is used to), which is slowly increased until it reaches a level we would expect to see by the end of the operation.
We will compare how fast children recover in each group and determine whether the way their oxygen was managed during the operation has any effect on their development in the long term.
Chief Investigator: Prof Massimo Caputo