Effects of goal-directed fluid management guided by a non-invasive device on the incidence of postoperative complications in neurosurgery: a pilot and feasibility randomized controlled trial

Abstract

Background The positive effects of goal-directed hemodynamic therapy (GDHT) on patient-orientated outcomes have been demonstrated in various clinical scenarios; however, the effects of fluid management in neurosurgery remain unclear. Therefore, this study was aimed at assessing the safety and feasibility of GDHT using non-invasive hemodynamic monitoring in elective neurosurgery. The incidence of postoperative complications was compared between GDHT and control groups. Methods We conducted a single-center randomized pilot study with an enrollment target of 34 adult patients scheduled for elective neurosurgery. We randomly assigned the patients equally into control and GDHT groups. The control group received standard therapy during surgery and postoperatively, whereas the GDHT group received therapy guided by an algorithm based on non-invasive hemodynamic monitoring. In the GDHT group, we aimed to achieve and sustain an optimal cardiac index by using non-invasive hemodynamic monitoring and bolus administration of colloids and vasoactive drugs. The number of patients with adverse events, feasibility criteria, perioperative parameters, and incidence of postoperative complications was compared between groups. Results We successfully achieved all feasibility criteria. The GDHT protocol was safe, because no patients in either group had unsatisfactory brain tissue relaxation after surgery or brain edema requiring therapy during surgery or 24 h after surgery. Major complications occurred in two (11.8%) patients in the GDHT group and six (35.3%) patients in the control group (p = 0.105). Conclusions Our results suggested that a large randomized trial evaluating the effects of GDHT on the incidence of postoperative complications in elective neurosurgery should be safe and feasible. The rate of postoperative complications was comparable between groups. Trial registration Trial registration: ClininalTrials.gov, registration number: NCT04754295, date of registration: February 15, 2021.

Intraoperative goal-directed fluid therapy in adult patients undergoing craniotomies under general anaesthesia: A systematic review and meta-analysis with trial sequential analysis

“…CI = confidence interval, FEM = fixed effects model; GDFT = goal-directed fluid therapy, REM = random effects model, RoB = risk of bias, Std = standard care Secondary outcomes: Postoperative complications: Six of the included RCTs reported the incidence of overall postoperative complications. [ 19 22 24 25 26 28 ] The pooled estimate revealed that GDFT patients had a significantly lower risk of postoperative complications than the control group [RR (95% CI) = 0.67 (0.54, 0.82), 95% PI = 0.39, 1.41, I 2 = 37%] [ Figure 2 b]. Pulmonary complications were reported in seven studies.…”

“…Pulmonary complications were reported in seven studies. [ 19 21 22 24 25 26 28 ] The pooled estimate showed a significant reduction in pulmonary complications with the use of GDFT compared to the control group [RR (95% CI) = 0.55 (0.38, 0.79), 95% PI = 0.35, 1.10, I 2 = 0%] [ Figure 2 c]. Renal complications were reported in three studies.…”

“…[ 19 20 21 22 23 24 27 28 ] The pooled MD did not show a significant difference in intraoperative blood loss between the GDFT and control groups [MD (95% CI) = -14.79 (-49.05, 19.46), 95% PI = −66.82, 38.38, I 2 = 33%] [ Figure 3 b]. Duration of ICU and hospital stay: A total of six RCTs reported the duration of ICU stay,[ 19 21 22 23 25 28 ] and eight studies reported the duration of hospital stay. [ 19 21 22 23 24 25 26 28 ] Patients in the GDFT group had significantly shorter ICU stays than the patients in the control group [MD (95% CI) = -1.6 (-3.02, -0.28)].…”

“…Duration of ICU and hospital stay: A total of six RCTs reported the duration of ICU stay,[ 19 21 22 23 25 28 ] and eight studies reported the duration of hospital stay. [ 19 21 22 23 24 25 26 28 ] Patients in the GDFT group had significantly shorter ICU stays than the patients in the control group [MD (95% CI) = -1.6 (-3.02, -0.28)]. The PI ranged from − 5.63 to 2.33 [ Figure 3 c].…”