# Deltex Medical Group plc Trial Results Show Oesophageal Doppler Monitoring System reduces complications by 75 per cent

- Link: https://www.directorstalkinterviews.com/deltex-medical-group-plc-trial-results-show-oesophageal-doppler-monitoring-system-reduces-complications-75-per-cent/412746517
- Published: 2018-03-01T07:16:22+00:00
- Author: Giles Arbor

**Deltex Medical Group plc** (LON: DEMG), the global leader in Oesophageal Doppler
Monitoring (“ODM”), today announced the results of the largest randomised controlled
trial to date of its proprietary fluid management and cardiac output ODM system.

Accepted for publication in the British Journal of Anesthesia, the FEDORA trial 
found use of ODM guided goal-directed haemodynamic therapy (“GDHT”) during major
elective surgery significantly reduces postoperative complications and length of
hospital 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, the FEDORA
trial was a prospective, multi-centre, randomised controlled trial aimed at evaluating
the impact of ODM guided administration of intravenous (IV) fluids and vasoactive
drugs on postoperative complications following major elective abdominal surgery.
420 patients were analysed as part of the trial. Patients were randomised to the
GDHT group or the control group. For patients in the GDHT group, anesthetists used
Deltex Medical’s CardioQ-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 incidence of 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 several specific major complications including acute kidney injury, acute pulmonary
oedema, respiratory distress syndrome, pneumonia, and both superficial and deep 
surgical site infection.

Furthermore, the number of patients suffering at least one post-operative complication
was halved and median length of stay for patients in the GDHT group was 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 oesophageal 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.”
> **Ewan Phillips, Deltex Medical Group plc Chief Executive, commented:** “Complications
> after surgery are unpleasant, expensive to treat and reduce patients’ post-operative
> survival. The ability to eliminate over half of these is of huge value to both
> patients and healthcare providers.
> “FEDORA is the most important randomised controlled trial yet of ODM. It is not
> only the largest ever randomised trial, but also the first multi-centre one. It
> highlights that monitored administration of vaso-active drugs as well as fluids
> is important in optimal haemodynamic management. It also shows that the benefits
> of ODM are achievable in patients who are otherwise considered low or moderate
> risk.”

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