Support for ODM from Largest Ever Intra-Op Haemodynamic RCT

The British Journal of Anaesthesia (BJA) has published a new study, the largest ever positive Randomised Clinical Trial (RCT) on Goal-Directed Haemodynamic Therapy(GDHT) using Deltex Medical’s ODM system. The results demonstrate that even surgical patients considered to be at low to medium risk benefit significantly from having GDHT using ODM. (GDHT as opposed to Goal-Directed Fluid Therapy (GDFT) offers a protocol that combines both fluid and drugs).

The paper concludes that monitoring all low-medium risk patients with ODM, then intervening with the right technology significantly reduces post-op complications, improving patient safety and saving money.

The newly published 420 patient study was conducted in Spain and funded by the Spanish Government. It was a prospective, multi-centre, randomised clinical trial aimed at evaluating the impact of ODM-guided administration of intravenous (IV) fluids and vasoactive drugs on post-operative complications following major surgery. Importantly, researchers performing patient evaluations were blinded to the treatment.

The paper is entitled “Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial” (FEDORA trial). Read it in full here.

Speaking for the company, Deltex Medical’s Managing Director Andy Mears says; “The results of the FEDORA study are entirely consistent with the previous body of clinical evidence for our technology and the NICE guidance.”

He adds; “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. Once again it proves that employing haemodynamic monitoring to guide appropriate interventions yields statistically significant reductions of between 75 per cent and 100 per cent in specific major complications. These include acute kidney injury, acute pulmonary oedema, respiratory distress syndrome, pneumonia, and superficial or deep surgical site infection.