A number of Randomised Controlled Trials (RCTs) have been conducted using the ODM to guide fluid management during surgery.
Most recently (March, 2018) British Journal of Anaesthesia published the biggest ever positive study into the use of Deltex’s ODM to guide fluid/drug therapy during anaesthesia. Importantly the paper focuses on major surgery undertaken on patients considered to be at low-moderate haemodynamic risk. It can be found here.
The 420 patient, multicentre, randomised, controlled, researcher-blinded study is titled: Effect of goal-directed haemodynamic therapy on postoperative complications in low–moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial), J.M. Calvo-Vecino, J. Ripollés-Melchor, M.G. Mythen, R. Casans-Francés, A. Balik, J.P. Artacho, E. Martínez-Hurtado, A. Serrano Romero, C. Fernández Pérez , S. Asuero de Lis
The discussion points out that “A haemodynamic optimization algorithm for management of low-moderate risk patients having major abdominal surgery significantly reduced postoperative complications in the 180 days after surgery. There was a decrease in AKI, acute respiratory distress syndrome, acute pulmonary oedema, pneumonia, and superficial or deep surgical site infection. LOS was shortened…”
See below for a summary of additional RCTs, or the Bibliography for a list of references.
St Thomas’ RCT, July 2016
- Length of Stay significantly shorter in ODM patients (6 vs. 8 days; p=0.01).
- Compared to ODM, LiDCOrapid has poor sensitivity and wide limits of agreement
- Significantly more LiDCOrapid patients treated with vasopressors (56% vs. 33%, p=0.01).
- ODM patients mobilised one day before LiDCOrapid ones (p=0.038).
- ODM and LiDCOrapid are not interchangeable.
Results from a 127 patients, single-centre, patient-blinded, randomised controlled trial for elective colorectal surgery within an enhanced recovery programme, were presented on 6th July 2016 at ACPGBI. Patients received simultaneous monitoring using oesphageal Doppler (ODM) and LiDCOrapid when undergoing both open and laparoscopic surgery. Following randomisation, anaesthetists used one monitor to guide fluid management whilst blinded to the other monitor.
The sensitivity of the LiDCOrapid device was 62%. The limits of agreement between the two monitors were -50% to 54% for percentage change in Stroke Volume (SV). There was no change in observed equivalence between the technologies when readings during vasopressor use or pneumoperitoneum were excluded.
The significant reduction in length of stay in ODM patients is consistent with the results of a meta-analysis of IOFM outcome benefit. Link
The authors concluded:
“Marked disagreement was observed in GDFT guided by LiDCOrapid versus ODM in colorectal ERP patients. Length of stay may be prolonged in the LiDCOrapid group”.
Spanish RCT, May 2016
- 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 (15% v 28%: p<0.01)
- 2 day reduction in median length of stay (p<0.01)
Results from a 450 patient Spanish Government funded multi-centre RCT were presented at Euroanaesthesia 2016. Patients undergoing major gastrointestinal, urological, gynaecological and orthopaedic surgery were managed using oesophageal Doppler to maintain an optimal Stroke Volume (SV), Mean Arterial Pressure (MAP) >70mmHg and Cardiac Index (CI) ≥2.5l/min/m2, when compared to conventional care.
This is the largest ever intra-operative fluid management RCT and the 12th RCT to show substantial improvements in patient outcomes from use of the 10% Stroke Volume Optimization algorithm guided by oesophageal Doppler.
ODM has since been recommended as the preferred monitor for use within the Spanish National Enhanced Recovery guidelines.
The authors concluded:
Fluid management using ODM guided SV, CI and MAP as “the key parameters, leads to a decrease in postoperative complications in patients undergoing major surgery”.