March 2, 2018
Multicenter randomized controlled trial results published; fewer complications translate to better patient outcomes and lower healthcare costs, as evidenced by NICE guidelines
Deltex Medical, the global leader in Esophageal Doppler Monitoring (ODM), today announced the results of the largest randomized controlled trial to date of its proprietary fluid management and cardiac output monitoring system.
Accepted for publication in the British Journal of Anesthesia, the FEDORA trial found use of ODM guided goal-directed hemodynamic therapy (GDHT) during major elective surgery significantly reduces postoperative complications and length of stay, adding to an already extensive evidence base for the company’s ODM technology.
Conducted by researchers in Spain and funded by the Spanish Government, “Effect of goal-directed hemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicenter randomized controlled trial” (FEDORA trial), was a prospective, multi-center, randomized clinical trial aimed at evaluating the impact of ODM guided administration of intravenous (IV) fluids and vasoactive drugs on postoperative complications following major surgery.
Complications after surgery are common, affecting around one patient in four. Half or more of these complications are both avoidable and attributable to periods of hemodynamic compromise while under anesthesia. They are unpleasant and expensive to treat; it typically costs the NHS c.£8,000 more to treat a patient with complications than one without. In the longer term, having a complication after surgery reduces the average patient’s post-operative survival by seven years.
ODM measures the rate of blood flow from the heart, allowing doctors to optimize patients’ hemodynamic status by giving the right amount of fluids and drugs at the right time. This protective intervention strategy, known as hemodynamic optimization, has been shown to reduce post-operative complications, and the costs associated with treating them, in higher risk patients.
The FEDORA trial included 420 low-moderate risk adult patients scheduled for major elective abdominal surgery at five university hospitals in Spain between 2011 and 2014. Patients were randomized to the goal-directed hemodynamic therapy (GDHT) group or the control group. For patients in the GDHT group, anesthetists used Deltex Medical’s ODM system to guide administration of fluids, inotropes and vasopressors by monitoring stroke volume, mean arterial pressure and cardiac index.
During the 180 days post-surgery, researchers measured the percentage of patients who developed moderate or severe post-operative complications in both the GDHT and control groups. They found those in the GDHT group experienced 75 per cent fewer complications. There were statistically significant reductions of between 75 per cent and 100 per cent in specific major complications including acute kidney injury (AKI), acute pulmonary oedema, respiratory distress syndrome, pneumonia, and superficial or deep surgical site infection.
Furthermore, the number of patients suffering at least one post-operative complication was halved and hospital length of stay for patients in the GDHT group was an average of two days shorter than the control group.
Lead researcher, Professor Jose María Calvo Vecino, Chief of Anesthesia and Intensive Care at the University of Salamanca, Spain, commented:
This powerful study isolates the impact of esophageal doppler monitoring. While clinicians understand the need to maintain optimal fluid balance and organ perfusion in patients considered to be at high risk, this study demonstrates a striking impact in the moderate risk surgical patient. Reducing overall risk of complication by half, and even more dramatic reduction in specific complications such as acute kidney injury, points to the significant potential of ODM technology if adopted as standard of care in this lower risk group.
Andy Mears, Deltex Medical’s Managing Director, commented:
The results of the FEDORA study are entirely consistent with the previous body of clinical evidence for our technology and the NICE guidance. The ability to reduce post-operative complications and, therefore, length of stay delivers benefits to the patient, clinician and healthcare provider in terms of higher quality clinical outcomes and reduced cost of care.
These study findings add to a growing body of evidence demonstrating the clinical and cost benefits of Deltex Medical’s ODM system. ODM was one of the very first products to go through the National Institute for Health and Care Excellence (NICE) medical technology evaluation pathway. In 2011, NICE recommended ODM for over 800,000 major surgical patients in NHS England each year and identified an average saving of £1,100 per patient. Subsequently ODM was selected as one of six high impact innovations in the NHS Innovation Health & Wealth (IHW) report with the intention of saving hundreds of millions of Pounds a year through full adoption at pace and scale. ODM is currently used in c.2 per cent of patients where it is recommended by NICE.