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A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients.

ABSTRACT: Background: This prospective multicentre pilot study of patients scheduled for elective major abdominal surgery aimed to validate the fluid challenge (FC) proposed by the closed-loop (CL) system via anaesthesiologist assessment. Methods: This was a phase II trial consisting of two inclusion stages (SIMON method). Each FC (250 mL saline solution for 10 min) proposed by the CL was systematically validated by the anaesthesiologist who could either confirm or refuse the FC or give FC without the CL system. A ≥ 95% agreement between the CL and the anaesthesiologist was considered acceptable. Results: The study was interrupted after interim analysis of the first 19 patients (10 men, median age = 61 years, median body mass index = 26 kg/m2). The anaesthesiologists accepted 165/205 (80%) of fluid boluses proposed by the CL. Median cardiac index (CI) was 2.9 (interquartile: IQ (2.7; 3.4) L/min/m2) and the median coefficient of variation (CV) for CI was 13% (10; 17). Fifteen out of nineteen patients (79%) had a mean CI > 2.5 L/min/m2 or spent > 85% surgery time with pulse pressure variation < 13%. No adverse events related to the CL were reported. Conclusion: In this study of patients scheduled for elective major abdominal surgery, the agreement between CL and anaesthesiologist for giving fluid challenge was 80%, suggesting that CL cannot replace the physician but could help in decision making.

SUBMITTER: Gricourt Y

PROVIDER: S-EPMC9505637 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients.

Gricourt Yann Y Prin Derre Camille C Demattei Christophe C Bertran Sébastien S Louart Benjamin B Muller Laurent L Simon Natacha N Lefrant Jean-Yves JY Cuvillon Philippe P Jaber Samir S Roger Claire C

Journal of personalized medicine 20220830 9

Background: This prospective multicentre pilot study of patients scheduled for elective major abdominal surgery aimed to validate the fluid challenge (FC) proposed by the closed-loop (CL) system via anaesthesiologist assessment. Methods: This was a phase II trial consisting of two inclusion stages (SIMON method). Each FC (250 mL saline solution for 10 min) proposed by the CL was systematically validated by the anaesthesiologist who could either confirm or refuse the FC or give FC without the CL ...[more]

PMID: 36143194

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Project description:IntroductionGoal-directed fluid therapy strategies have been shown to benefit moderate- to high-risk surgery patients. Despite this, these strategies are often not implemented. The aim of this study was to assess a closed-loop fluid administration system in a surgical cohort and compare the results with those for matched patients who received manual management. Our hypothesis was that the patients receiving closed-loop assistance would spend more time in a preload-independent state, defined as percentage of case time with stroke volume variation less than or equal to 12%.MethodsPatients eligible for the study were all those over 18 years of age scheduled for hepatobiliary, pancreatic or splenic surgery and expected to receive intravascular arterial blood pressure monitoring as part of their anesthetic care. The closed-loop resuscitation target was selected by the primary anesthesia team, and the system was responsible for implementation of goal-directed fluid therapy during surgery. Following completion of enrollment, each study patient was matched to a non-closed-loop assisted case performed during the same time period using a propensity match to reduce bias.ResultsA total of 40 patients were enrolled, 5 were ultimately excluded and 25 matched pairs were selected from among the remaining 35 patients within the predefined caliper distance. There was no significant difference in fluid administration between groups. The closed-loop group spent a significantly higher portion of case time in a preload-independent state (95 ± 6% of case time versus 87 ± 14%, P =0.008). There was no difference in case mean or final stroke volume index (45 ± 10 versus 43 ± 9 and 45 ± 11 versus 42 ± 11, respectively) or mean arterial pressure (79 ± 8 versus 83 ± 9). Case end heart rate was significantly lower in the closed-loop assisted group (77 ± 10 versus 88 ± 13, P =0.003).ConclusionIn this case-control study with propensity matching, clinician use of closed-loop assistance resulted in a greater portion of case time spent in a preload-independent state throughout surgery compared with manual delivery of goal-directed fluid therapy.Trial registrationClinicalTrials.gov Identifier: NCT02020863. Registered 19 December 2013.

Project description:Optimal perioperative fluid management is crucial, with over- or under-replacement associated with complications. There are many strategies for fluid therapy, including liberal fluid therapy (LFT), restrictive fluid therapy (RFT) and goal-directed fluid therapy (GDT), without a clear consensus as to which is better. We aimed to find out which is the more effective fluid therapy option in adult surgical patients undergoing non-vascular abdominal surgery in the perioperative period. This study is a systematic review and network meta-analysis (NMA) with node-splitting analysis of inconsistency, sensitivity analysis and meta-regression. We conducted a literature search of Pubmed, Cochrane Library, EMBASE, Google Scholar and Web of Science. Only studies comparing restrictive, liberal and goal-directed fluid therapy during the perioperative phase in major non-cardiac surgery in adult patients will be included. Trials on paediatric patients, obstetric patients and cardiac surgery were excluded. Trials that focused on goal-directed therapy monitoring with pulmonary artery catheters and venous oxygen saturation (SvO2), as well as those examining purely biochemical and laboratory end points, were excluded. A total of 102 randomised controlled trials (RCTs) and 78 studies (12,100 patients) were included. NMA concluded that goal-directed fluid therapy utilising FloTrac was the most effective intervention in reducing the length of stay (LOS) (surface under cumulative ranking curve (SUCRA) = 91%, odds ratio (OR) = -2.4, 95% credible intervals (CrI) = -3.9 to -0.85) and wound complications (SUCRA = 86%, OR = 0.41, 95% CrI = 0.24 to 0.69). Goal-directed fluid therapy utilising pulse pressure variation was the most effective in reducing the complication rate (SUCRA = 80%, OR = 0.25, 95% CrI = 0.047 to 1.2), renal complications (SUCRA = 93%, OR = 0.23, 95% CrI = 0.045 to 1.0), respiratory complications (SUCRA = 74%, OR = 0.42, 95% CrI = 0.053 to 3.6) and cardiac complications (SUCRA = 97%, OR = 0.067, 95% CrI = 0.0058 to 0.57). Liberal fluid therapy was the most effective in reducing the mortality rate (SUCRA = 81%, OR = 0.40, 95% CrI = 0.12 to 1.5). Goal-directed therapy utilising oesophageal Doppler was the most effective in reducing anastomotic leak (SUCRA = 79%, OR = 0.45, 95% CrI = 0.12 to 1.5). There was no publication bias, but moderate to substantial heterogeneity was found in all networks. In preventing different complications, except mortality, goal-directed fluid therapy was consistently more highly ranked and effective than standard (SFT), liberal or restricted fluid therapy. The evidence grade was low quality to very low quality for all the results, except those for wound complications and anastomotic leak.

Project description:BackgroundSeveral randomized controlled trials suggest that goal-directed fluid therapy (GDFT) may result in improved postoperative outcomes. The aim of this study was to assess the clinical and financial impact of the real-life implementation of intraoperative GDFT in patients undergoing elective gastrointestinal surgery in a Chinese tertiary medical center.MethodsThis Quality Improvement Program (QIP) study comprised three phases of 5, 1, and 5 months, respectively. During the first phase, we retrospectively collected perioperative data from patients who received standard intraoperative fluid management from January to May 2016. Then a 1-month training period allowed the clinical staff to become familiar with the GDFT protocol. After the training phase, GDFT was used from July to November 2016. In the GDFT group, stroke volume (SV) was continuously monitored and optimized towards the plateau of the Frank-Starling curve. The primary outcome measure was postoperative morbidity (the proportion of patients with one or more complications within 30 days after surgery). Secondary outcomes were total hospital cost, postoperative length of hospital stay, and 30-day mortality.ResultsData from 200 patients before (control group) and 201 patients after the implementation of GDFT (GDFT group) were collected and compared. There was no significant difference in demographics and surgical procedures between the two groups. Postoperative morbidity was significantly lower in the GDFT group than in the control group (30.8% vs. 44.0%, p = 0.006). No significant differences were observed for mean total hospital cost (76,793 RMB vs. 74,444 RMB; p = 0.430), median postoperative length of hospital stay (10 days vs. 10 days; p = 0.104), and 30-day mortality (1% vs. 0.5%; p = 0.565).ConclusionIn patients undergoing gastrointestinal surgery, the implementation of a GDFT protocol was associated with a reduction in postoperative morbidity without increasing costs.Trial registrationclinicaltrials.gov, NCT02507557. Registered 13 July 2015.

Project description:BackgroundFluid management of the surgical patient has undergone a paradigm shift over the past decade. A change from 'wet' to 'dry' to a 'goal-directed' approach has been witnessed. The fluid management of patients undergoing free flap reconstruction is particularly challenging. This is typically a long operation with minimal surgical stimulation, and hypotension often ensues. The use of vasopressors in these cases is contraindicated to maintain adequate flow to the flap. Hypotension is often treated with intravenous fluid boluses. However, aggressive fluid administration to maintain adequate blood pressure can result in flap edema, venous engorgement and, ultimately, flap loss.ObjectiveThe primary objective of the present study was to determine whether goal-directed fluid therapy, titrated to maintain stroke volume variation ≤13%, with the use of an arterial pulse contour device results in improved postoperative cardiac index (CI) and stroke volume index (SVI) with reduced amounts of intravenous fluid. The primary end points studied were CI, SVI and cumulative crystalloid/colloid administration.MethodsTwenty female patients undergoing simultaneous microvascular free flap reconstruction immediately following mastectomy were studied. Preoperative and intraoperative care were standardized. Each patient received intra-arterial blood pressure monitoring. In all patients, cardiac output measurement occurred throughout the intraoperative period using the arterial pulse contour device. Control patients had their fluid administered at the discretion of the anesthesiologist (blinded to results from the cardiac output device). Patients in the intervention group had a baseline crystalloid infusion of 5 mL/kg/h, with intravenous colloid boluses to maintain a stroke volume variation ≤13%.ResultsThere was no difference in heart rate or mean arterial pressure between groups at the end of the operation. However, at the end of the operation, the intervention group had significantly higher mean (± SD) CI (3.8±0.8 L/min/m(2) versus 3.0±0.5 L/min/m(2); P=0.02) and SVI (51.4±2.4 mL/m(2) versus 43.3±2.3 mL/m(2); P=0.03). This improved CI and SVI was achieved with similar amounts of administered intraoperative fluid (5.8±0.5 mL/kg/h versus 5.0±0.7 mL/kg/h, control versus intervention). The intervention group required less postoperative fluid resuscitation during the early postoperative period (total fluid administered from end of operation to midnight of the operative day, 6.4±1.9 mL/kg/h versus 10.2±3.3 mL/kg/h, intervention versus control, respectively, P<0.01).DiscussionGoal-directed fluid therapy using minimally invasive cardiac output monitoring resulted in improved end-operative hemodynamics, with less 'rescue' fluid administration during the perioperative period.

Project description:BackgroundGoal-directed fluid therapy (GDFT) based on dynamic indicators of fluid responsiveness has been shown to decrease postoperative complications and hospital length of stay (LOS) in patients undergoing major abdominal surgery. The usefulness of this approach still needs to be clarified in low-to-moderate risk abdominal surgery. Both pulse-pressure variation (PPV) and pleth variability index (PVI) can be used to guide GDFT strategies. The objective of this prospective randomized controlled trial was to determine if the use of PVI guided GDFT, when compared to PPV guided GDFT, would lead to similar hospital LOS in patients undergoing low-to-moderate risk surgery. Secondary outcomes included amount of fluid administered and incidence of postoperative complications.MethodsPatients were randomized into either PVI or PPV guided GDFT groups. Both received a baseline 2 ml kg- 1 h- 1 Lactated Ringer infusion. Additional fluid boluses consisted of 250 mL of colloid that was infused over a 10 min period if PVI was > 15% or PPV was > 13% for at least five minutes. The primary outcome was to determine if hospital LOS, which was defined as the number of days from surgery up to the day the surgeon authorized hospital discharge, was equivalent between the two groups.ResultsA total of 76 patients were included and they were randomized into two groups of 38 patients. Baseline characteristics were similar in both groups. Both PVI and PPV guided GDFT strategies were equivalent for the primary outcome of LOS (median [interquartile range]) (days) 2.5 [2.0-3.3] vs. 3.0 [2.0-5.0], p = 0.230, respectively. Fluids infused, postoperative complications, and all other outcomes were not different between groups.ConclusionIn patients undergoing low-to-moderate risk abdominal surgery, PVI seems to guide GDFT similarly to PPV in regards to hospital LOS, amount of fluid, and incidence of postoperative complications. However, in low-risk patients undergoing these surgical procedures optimizing stroke volume may have limited impact on outcome.Trial registrationClinicalTrials.gov Identifier: NCT02908256 , September 2016, retrospectively registered.

Dataset Information

A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients.

Publications

A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients.

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