Pleth variability index or stroke volume optimization during open abdominal surgery: a randomized controlled trial.

BACKGROUND

The impact of Goal Directed Fluid Therapy (GDFT) based on the non-invasive Pleth Variability Index (PVI) on clinical outcome after abdominal surgery has only sparingly been explored. The purpose of this study was to compare the effect of intraoperative GDFT guided by PVI to a control group using esophageal Doppler on the incidence of complications and length of hospital stay after major abdominal surgery. We hypothesized that there would be no difference between the groups.

METHODS

This was a randomized controlled trial in a Swedish university hospital between November 2011 and January 2015; 150 patients scheduled for open abdominal surgery lasting 2 h or more were included. Exclusion criteria included hepatic resection or severe cardiac arrhythmia. The patients were randomized 1:1 to either the intervention group or the control group. The intervention group received intraoperative GDFT by administering fluid boluses of 3 ml/kg tetrastarch aiming at a PVI value below 10%, while GDFT in the control group aimed for optimization of stroke volume as assessed with esophageal Doppler. Blinded observers assessed complications until postoperative day 30 using pre-defined definitions, as well as length of hospital stay.

RESULTS

One hundred and-fifty patients were randomized and 146 patients were available for the final data analysis. Median duration of surgery was 3 h. A total of 64 complications occurred in the PVI group (N = 74) and 70 in the Doppler group (N = 72) (p = 0.93). Median (IQR) length of stay was 8.0 (8.0) days in the PVI group and 8.0 (9.5) in the Doppler group (P = 0.57).

CONCLUSIONS

No difference in clinical outcome, as defined by number of postoperative complications, and length of hospital stay, was found when goal directed fluid therapy was applied using PVI as an alternative to esophageal Doppler. PVI appears to be an acceptable alternative to esophageal Doppler for goal directed fluid therapy during major open abdominal surgery.

TRIAL REGISTRATION

Clinicaltrials.gov NCT01458678 . Date of first registration October 20, 2011.