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RCTs

RCTs

A number of Randomised Controlled Trials (RCTs) have been conducted using the ODM to guide fluid management during surgery. See below for a summary of each, or the Bibliography for a list of references.

St Thomas’ RCT, July 2016

Summary
  • 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.
Method

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.

Outcomes

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 improvement when readings during vasopressor use or pneumoperitoneum were excluded. Nordstrom et al (2013) found similar results with a poorer sensitivity of 48% and limits of agreement of -20% to 18%. Nordstrom et al also concluded that LiDCOrapid and ODM are not interchangeable.

 

As LiDCOrapid is unable to adequately detect prompts for fluid therapy in surgery, 38% of the time, this explains why LiDCOrapid fails to demonstrate significant reductions in complications or length of stay. Large single and multi-centre RCTs using PPWA devices, including OPTIMISE, have tried and failed to show the same benefits that have been demonstrated, time and time again, with the superior Doppler technology.

Conclusion

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

Summary
  • 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)
Method

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.

Outcome

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.

Conclusion

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”.