A newly published 420 patient multicentre, prospective RCT demonstrates once more the power of intraoperative haemodynamic monitoring in preventing postoperative complications, says Deltex Medical.
Complications after surgery are common, affecting around one patient in four to varying degree. Half or more of these avoidable complications are attributable to periods of haemodynamic compromise while under anaesthesia, says haemodynamic monitoring expert company, Deltex Medical. Complications are unpleasant and expensive to treat; it typically costs the NHS c.£8,000 more to treat a compromised patient. And in the longer term, having a complication after surgery reduces the average patient’s post-operative survival by seven years.
Deltex Medical’s ODM technology employs a probe, placed in the oesophagus to directly measure the rate of blood flow from the heart. The resultant real-time data allows doctors to optimise patients’ haemodynamic status by giving the right amount of fluids and drugs at the right time. This protective intervention strategy has a weight of evidence behind it that shows reduced post-operative complications, and the costs associated with treating them, in higher risk patients.
The newly published study adds to the body of evidence by investigating the impact of such monitoring-guided intervention in low to moderate risk patients. Funded by the Spanish government, and independently performed across multiple sites in Spain, this is the largest randomised controlled trial to date to employ Deltex’s proprietary ODM fluid management and cardiac output monitoring system.
Published in the British Journal of Anaesthesia, the so-called FEDORA trial found use of ODM-guided goal-directed haemodynamic therapy (GDHT) during major elective surgery significantly reduces postoperative complications and length of stay in a low to moderate risk patient population. Deltex says the data is consistent with an already extensive evidence base for the company’s ODM technology.
The paper is titled “Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial” (FEDORA trial).
The prospective, multi-centre, randomised clinical trial aimed at evaluating the impact of ODM guided administration of intravenous (IV) fluids and vasoactive drugs on postoperative complications following major surgery. Significantly patient assessment was performed by researchers blinded to the original treatment.
450 low-moderate risk adult patients underwent major elective abdominal surgery at five university hospitals in Spain between 2011 and 2014. Patients were randomised to the goal-directed haemodynamic 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. 420 patients were ultimately enrolled in the study.
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.
“This powerful study isolates the impact of oesophageal doppler monitoring,” said lead researcher Professor Jose María Calvo Vecino, Chief of Anaesthesia and Intensive Care at the University of Salamanca in Salamanca, Spain.
“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.”
“The results of the FEDORA study are entirely consistent with the previous body of clinical evidence for our technology and the NICE guidance,” said the Deltex Medical Managing Director Andy Mears.
“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.”
Source: Deltex Medical Ltd.