Dataset Information

Tissue oxygenation as a target for goal-directed therapy in high-risk surgery: a pilot study.

ABSTRACT: Tissue hypoperfusion occurs frequently during surgery and may contribute to postoperative organ dysfunction. There is a need for perioperative treatment protocols aiming at improving tissue oxygenation (StO2). We hypothesised that intra-operative optimisation of StO2 improves tissue perfusion and thus reduces postoperative complications. Furthermore, we evaluated the feasibility of the optimisation algorithm used.We randomized 50 high-risk patients, all >65 years with ASA physical status III, who underwent major abdominal surgery under standardized balanced general anesthesia combined with epidural analgesia. Throughout surgery StO2 was monitored at the thenar eminence using near-infrared spectroscopy. All patients were treated according to a standard care algorithm. In addition, patients in the intervention group were treated with dobutamine if necessary to keep or raise StO2???80%. Data were recorded continuously and complications were recorded during hospital stay with a maximum of 28 days.The number of complications was not significantly different between groups (11 vs 20; p = 0.23). Eleven patients in the intervention group had no complication, versus 7 in the control group. There was no significant difference between groups in length of stay in ICU or in hospital. Only ten patients in the intervention group received dobutamine. Administration of dobutamine resulted in a moderate 6 [-3 to 10] % increase of StO2. The overall protocol adherence was 94%.No statistically significant difference in outcome was realized through intraoperative optimization of StO2 values in this pilot study. The protocol used may be considered feasible for clinical practice. Further research is obligatory to define both the optimal StO2 threshold and intervention to treat tissue hypoperfusion.ClinicalTrials.gov identifier: NCT01342900. Registered 21 April 2011.

SUBMITTER: van Beest PA

PROVIDER: S-EPMC4289564 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Tissue oxygenation as a target for goal-directed therapy in high-risk surgery: a pilot study.

van Beest Paul A PA Vos Jaap Jan JJ Poterman Marieke M Kalmar Alain F AF Scheeren Thomas W L TW

BMC anesthesiology 20141216

<h4>Background</h4>Tissue hypoperfusion occurs frequently during surgery and may contribute to postoperative organ dysfunction. There is a need for perioperative treatment protocols aiming at improving tissue oxygenation (StO2). We hypothesised that intra-operative optimisation of StO2 improves tissue perfusion and thus reduces postoperative complications. Furthermore, we evaluated the feasibility of the optimisation algorithm used.<h4>Methods</h4>We randomized 50 high-risk patients, all >65 yea ...[more]

PMID: 25580087

Similar Datasets

Project description:BackgroundBreast reconstruction is an integral part of breast cancer care. There are 2 main types of breast reconstruction: alloplastic (using implants) and autologous (using the patient's own tissue). The latter creates a more natural breast mound and avoids the long-term need for surgical revision-more often associated with implant-based surgery. The deep inferior epigastric perforator (DIEP) flap is considered the gold standard approach in autologous breast reconstruction. However, complications do occur with DIEP flap surgery and can stem from poor flap tissue perfusion/oxygenation. Hence, the development of strategies to enhance flap perfusion (eg, goal-directed perioperative fluid therapy) is essential. Current perioperative fluid therapy is traditionally guided by subjective criteria, which leads to wide variations in clinical practice.ObjectiveThe main objective of this trial is to determine whether the use of minimally invasive cardiac output (CO) monitoring for guiding intravenous fluid administration, combined with low-dose dobutamine infusion (via a treatment algorithm), will increase tissue oxygenation in patients undergoing DIEP flap surgery.MethodsWith appropriate institutional ethics board and Health Canada approval, patients undergoing DIEP flap surgery are randomly assigned to receive CO monitoring for the guidance of intraoperative fluid therapy in addition to a low-dose dobutamine infusion (which potentially improves flap oxygenation) versus the current standard of care. The primary outcome is tissue oxygenation measured via near-infrared spectroscopy at the perfusion zone furthest from the perforator vessels 45 minutes after vascular reanastomosis of the DIEP flap. Low dose (2.5 μg/kg/hr) dobutamine infusion continues for up to 4 hours postoperatively, provided there are no associated complications (ie, persistent tachycardia). Flap oxygenation, hemodynamic parameters, and any medication-associated side effects/complications are monitored for up to 48 hours postoperatively. Complications, rehospitalizations, and patient satisfaction are also collected until 30 days postoperatively.ResultsFunding and regulatory approvals were obtained in 2019, but the study recruitment was interrupted by the COVID-19 pandemic. As of October 4, 2023, 34 participants have been recruited. Because of the significant delays associated with the pandemic, the expected completion date was extended. We expect the study to be completed and ready for potential news release (as appropriate) and publication by July 2024. No patients have suffered any adverse effects/complications from participating in this study, and none have been lost to follow-up.ConclusionsCO-directed fluid therapy in combination with a low-dose dobutamine infusion via a treatment algorithm has the potential to improve DIEP flap tissue oxygenation and reduce complications following DIEP flap breast reconstruction surgery. However, given that the investigators remain blinded to group randomization, no comment can be made regarding the efficacy of this intervention for improving tissue oxygenation at this time. Nevertheless, no patients have been withdrawn for safety concerns thus far, and compliance remains high.Trial registrationClinicaltrials.gov NCT04020172; https://clinicaltrials.gov/study/NCT04020172.

Project description:BACKGROUND:Perioperative goal-directed hemodynamic therapy (GDHT) has been advocated in high-risk patients undergoing noncardiac surgery to reduce postoperative morbidity and mortality. We hypothesized that using cardiac index (CI)-guided GDHT in the postoperative period for patients undergoing high-risk surgery for cancer treatment would reduce 30-day mortality and postoperative complications. METHODS:A randomized, parallel-group, superiority trial was performed in a tertiary oncology hospital. All adult patients undergoing high-risk cancer surgery who required intensive care unit admission were randomly allocated to a CI-guided GDHT group or to a usual care group. In the GDHT group, postoperative therapy aimed at CI ≥ 2.5 L/min/m2 using fluids, inotropes and red blood cells during the first 8 postoperative hours. The primary outcome was a composite endpoint of 30-day all-cause mortality and severe postoperative complications during the hospital stay. A meta-analysis was also conducted including all randomized trials of postoperative GDHT published from 1966 to May 2017. RESULTS:A total of 128 patients (64 in each group) were randomized. The primary outcome occurred in 34 patients of the GDHT group and in 28 patients of the usual care group (53.1% vs 43.8%, absolute difference 9.4 (95% CI, - 7.8 to 25.8); p = 0.3). During the 8-h intervention period more patients in the GDHT group received dobutamine when compared to the usual care group (55% vs 16%, p < 0.001). A meta-analysis of nine randomized trials showed no differences in postoperative mortality (risk ratio 0.85, 95% CI 0.59-1.23; p = 0.4; p for heterogeneity = 0.7; I2 = 0%) and in the overall complications rate (risk ratio 0.88, 95% CI 0.71-1.08; p = 0.2; p for heterogeneity = 0.07; I2 = 48%), but a reduced hospital length of stay in the GDHT group (mean difference (MD) - 1.6; 95% CI - 2.75 to - 0.46; p = 0.006; p for heterogeneity = 0.002; I2 = 74%). CONCLUSIONS:CI-guided hemodynamic therapy in the first 8 postoperative hours does not reduce 30-day mortality and severe complications during hospital stay when compared to usual care in cancer patients undergoing high-risk surgery. TRIAL REGISTRATION:www.clinicaltrials.gov , NCT01946269 . Registered on 16 September 2013.

Project description:Goal-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%.Patients 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.A 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).In 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.ClinicalTrials.gov Identifier: NCT02020863. Registered 19 December 2013.

Project description:Central venous oxygen saturation (ScvO2) is a useful therapeutic target in septic shock and high-risk surgery. We tested the hypothesis that central venous-to-arterial carbon dioxide difference (P(cv-a)CO2), a global index of tissue perfusion, could be used as a complementary tool to ScvO2 for goal-directed fluid therapy (GDT) to identify persistent low flow after optimization of preload has been achieved by fluid loading during high-risk surgery.This is a secondary analysis of results obtained in a study involving 70 adult patients (ASA I to III), undergoing major abdominal surgery, and treated with an individualized goal-directed fluid replacement therapy. All patients were managed to maintain a respiratory variation in peak aortic flow velocity below 13%. Cardiac index (CI), oxygen delivery index (DO2i), ScvO2, P(cv-a)CO2 and postoperative complications were recorded blindly for all patients.A total of 34% of patients developed postoperative complications. At baseline, there was no difference in demographic or haemodynamic variables between patients who developed complications and those who did not. In patients with complications, during surgery, both mean ScvO2 (78 ± 4 versus 81 ± 4%, P = 0.017) and minimal ScvO2 (minScvO2) (67 ± 6 versus 72 ± 6%, P = 0.0017) were lower than in patients without complications, despite perfusion of similar volumes of fluids and comparable CI and DO2i values. The optimal ScvO2 cut-off value was 70.6% and minScvO2 < 70% was independently associated with the development of postoperative complications (OR = 4.2 (95% CI: 1.1 to 14.4), P = 0.025). P(cv-a)CO2 was larger in patients with complications (7.8 ± 2 versus 5.6 ± 2 mmHg, P < 10-6). In patients with complications and ScvO2 ? 71%, P(cv-a)CO2 was also significantly larger (7.7 ± 2 versus 5.5 ± 2 mmHg, P < 10-6) than in patients without complications. The area under the receiver operating characteristic (ROC) curve was 0.785 (95% CI: 0.74 to 0.83) for discrimination of patients with ScvO2 ? 71% who did and did not develop complications, with 5 mmHg as the most predictive threshold value.ScvO2 reflects important changes in O2 delivery in relation to O2 needs during the perioperative period. A P(cv-a)CO2 < 5 mmHg might serve as a complementary target to ScvO2 during GDT to identify persistent inadequacy of the circulatory response in face of metabolic requirements when an ScvO2 ? 71% is achieved.Clinicaltrials.gov Identifier: NCT00852449.

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.

Dataset Information

Tissue oxygenation as a target for goal-directed therapy in high-risk surgery: a pilot study.

Publications

Tissue oxygenation as a target for goal-directed therapy in high-risk surgery: a pilot study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets