Ewan Phillips, Deltex Medical’s Chief Executive, commented: “These are superb results from the largest ever ODM randomised controlled trial. They confirm the unique ability of ODM to help doctors eliminate more than half of dangerous complications after surgery. They bring the robust evidence base for ODM right up to date and confirm both the high value and the wide applicability of our ODM products. Complications after surgery are expensive to treat and reduce post-operative survival by an average of over seven years for each patient who suffers one.
“We are pursuing a number of options to expand our business in Spain to exploit the opportunities which would follow a successful national roll-out of enhanced recovery approaches to surgery.”
Excellent results from Spanish multi-centre ODM trial presented at major international clinical conference: ODM adopted into new national clinical guidelines in Spain
Deltex Medical Group plc (AIM: DEMG), the global leader in oesophageal Doppler monitoring (“ODM”), today gave DirectorsTalk the initial results of the largest ever randomised clinical trial of ODM which show substantial reductions in post-operative complications.
A group of doctors from Spain, led by Professor Jose Maria Calvo Vecino, presented the findings from their 450 patient multi-centre randomised controlled trial to doctors attending Euroanaesthesia 2016 in London, the annual meeting of the European Society of Anaesthesia. The trial was undertaken in five hospitals and included patients undergoing gastrointestinal, urological, gynaecological and orthopaedic surgery. Professor Calvo is head of the Department of Anaesthesia and Critical Care at the Infanta Leonor Universtity Hospital in Madrid and Vice President of the Spanish Society of Anaesthesia.
The trial, the first completed multi-centre randomised controlled trial of ODM during surgery, showed:
-- 72% reduction in total number of complications from 198 to 56 (p<0.01)
— 45% reduction in number of patients suffering one or more complications meaning Doppler use saved 28 additional patients from suffering any complication at all (15% v 28%: p<0.01)
-- 2 day reduction in median length of stay (p<0.01)
In addition the study found statistically significant reductions in five types of major complication:
-- Acute Kidney Injury: 75% reduction (5 patients v 21) -- Cardiopulmonary oedema: 100% reduction (0 v 13) -- Pneumonia: 83% reduction (4 v 22) -- Superficial surgical site infection: 75% reduction (4 v 16) -- Deep surgical site infection: 74% reduction (6 v 23)
Intra-operative fluid management has been adopted within the Spanish Society of Enhanced Recovery (‘SSER’) national clinical guidelines which have been developed for major surgery, for example http://portal.guiasalud.es/contenidos/iframes/documentos/opbe/2015-07/ViaClinica-RICA_English.pdf. These guidelines note that “Monitoring with oesophagic Doppler is preferred, or else methods based on validated pulse contour analyses”. The Company understands that SSER, with the backing of both national and regional health systems, intends to start rolling out their guidelines into selected hospitals during the second half of the year.
