Goal directed fluid and hemodynamic therapy with trans-thoracic echocardiographic aortic blood flow peak velocity variation in children and postoperative outcome : A randomized controlled trial protocol

Background : While several parameters of fluid responsiveness have been validated in adults, they cannot be directly applied in children primarily because of the pediatric specificities of the cardiovascular system. Respiratory variation of Aortic Blood Flow Peak Velocity (ΔVpeak) has been promoted as an accurate predictor of fluid responsiveness in children. Therefore, we aim at characterizing the potential impact of optimization of intraoperative hemodynamic condition using goal directed fluid and hemodynamic therapy (GDFHT based on ΔVpeak assessed by transthoracic echocardiography on postoperative outcome in children. Methods : Children aged less than 18 years old and admitted for major non cardiac surgery will be eligible. After obtaining parental consent, children will be randomized into two groups: Group GD, where fluid and hemodynamic therapy will be guided with ΔVpeak and Group SC, with fluid and hemodynamic therapy managed according to routine. Primary Outcome will be postoperative morbidity until 30 days postoperatively defined as surgical and/or organ failure. Secondary outcome will include length of stay in the intensive care unit, length of mechanical ventilation and length of hospital stay. Based on the primary end-point, 400 patients are required in order to have a significant difference between the two groups. Results and Conclusions : This multicenter randomized controlled trial will clarify the impact of GDFHT based on ΔVpeak assessed by transthoracic echocardiography on postoperative outcomes in children undergoing elective or urgent major non-cardiac surgery.