WHICH CARDIAC OUTPUT MONITOR IN COLORECTAL ENHANCED RECOVERY? :

Transcription

1 WHICH CARDIAC OUTPUT MONITOR IN COLORECTAL ENHANCED RECOVERY? : RANDOMISED CONTROLLED NON-INFERIORITY TRIAL COMPARING LiDCOrapid AND OESOPHAGEAL DOPPLER MONITORS J van Dellen, S McCorkell, AB Williams Guy s and St. Thomas NHS Foundation Trust, King s College London ACPGBI 2016 Annual Meeting, Edinburgh 6 th July 2016

2 GOAL-DIRECTED FLUID THERAPY Stroke volume (SV) response to increased in intravascular volume Grocott et al 2005, Anesth Analg

3 CARDIAC OUTPUT MONITORS Oesophageal Doppler Doppler velocimetry aorta flow from oesophageal probe Initial NICE recommendation Robust evidence base LiDCOrapid Pulse pressure arterial waveform analysis from arterial line Few validation & outcome studies OPTIMISE trial Poor agreement between monitors in stroke volume optimisation Small non-randomised comparison studies (<25 patients) Nordstrom et al 2012, Br J Anaesth; Davies et al 2013, J Clin Anesth; Feldheiser et al 2015, PLOS One

4 AIMS Hypothesis ODM & LiDCOrapid cardiac output monitors can be used interchangeably to guide goal-directed fluid therapy for colorectal surgery patients within an Enhanced Recovery protocol with non-inferior outcomes Primary Outcome Length of stay Secondary outcomes Agreement between monitors Mortality & morbidity Change in oxygen delivery index (DO2i)

5 METHODS Colorectal ERAS patients Non-inferiority randomised controlled trial (ISRCTN ) Participant randomised to either ODM & LiDCOrapid monitoring Colloid fluid challenges to determine if SV >10% Simultaneous monitoring with both monitors to measure agreement Anaesthetist blinded to other monitor Participants blinded to allocation Sample size: Exclusion criteria: based on 3-day clinically significant difference in length of stay = 336 participants no arterial line, contraindication to LiDCOrapid or ODM, pregnant, <18yo, no capacity for consent

6 RESULTS 16 months 127 participants (64 ODM vs. 63 LiDCOrapid) 1325 paired measurements 40% colonic surgery laparoscopic No significant differences in: Patient characteristics Co-morbidities Surgical complexity Open vs lap. approach Risk factors for prolonged LOS incl. compliance

7 RESULTS No differences in: Intra-op: End of Surgery: Post-op: Total, colloid or crystalloid IV fluid volume Number of fluid challenges DO 2 i DO 2 i Lactate Restitution GI function Morbidity Mortality More intra-op vasopressor use in LiDCOrapid group (56 vs 33%, p = 0.01) Median post-operative length of stay significantly longer in LiDCOrapid group (8 vs. 6 days, p = 0.012)

8 RESULTS - AGREEMENT Poor agreement % SV 95% limits agreement -50 to +54% (SD ±19%) Poor agreement DO 2 i 95% limits agreement -283 to +368 (SD ±121) ml/min/m 2 No improvement when excluded readings during vasopressor use or pneumoperitoneum.

9 RESULTS - AGREEMENT % SV LiDCOrapid Comparison of indication for fluid bolus when SV change >10% ODM <10% 10% <10% % paired measurements Poor agreement filling status Kappa = 0.14 (95% CI 0.04 to 0.23) Post-hoc sample size calculations confirms validity of agreement studies

10 CONCLUSION Marked disagreement was observed in GDFT guided by LiDCOrapid versus ODM in standardised colorectal ERAS patients. Length of stay may be prolonged in the LiDCOrapid group. Further comparison studies should concentrate on outcomes and will need to be much larger

11 REFERENCES 1. GROCOTT, M. P., MYTHEN, M. G. & GAN, T. J Perioperative fluid management and clinical outcomes in adults. Anesth Analg, 100, NORDSTROM, J., HALLSJO-SANDER, C., SHORE, R. & BJORNE, H Stroke volume optimization in elective bowel surgery: a comparison between pulse power wave analysis (LiDCOrapid) and oesophageal Doppler (CardioQ). Br J Anaesth, 110, DAVIES, S. J., MINHAS, S., WILSON, R. J., YATES, D. & HOWELL, S. J Comparison of stroke volume and fluid responsiveness measurements in commonly used technologies for goal-directed therapy. J Clin Anesth, 25, FELDHEISER, A., PAVLOVA, V., WEIMANN, K., HUNSICKER, O., STOCKMANN, M., KOCH, M., GIEBELS, A., WERNECKE, K. D. & SPIES, C. D Haemodynamic Optimization by Oesophageal Doppler and Pulse Power Wave Analysis in Liver Surgery: A Randomised Controlled Trial. PLoS One, 10, e PEARSE, R. M., HARRISON, D. A., MACDONALD, N., GILLIES, M. A., BLUNT, M., ACKLAND, G., GROCOTT, M. P., AHERN, A., GRIGGS, K., SCOTT, R., HINDS, C. & ROWAN, K Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. Jama, 311,