Impact of conventional vs. goal-directed fluid therapy on urethral tissue perfusion in patients undergoing liver surgery: A pilot randomised controlled trial.

BACKGROUND: Although fluid administration is a key strategy to optimise haemodynamic status and tissue perfusion, optimal fluid administration during liver surgery remains controversial. OBJECTIVE: To test the hypothesis that a goal-directed fluid therapy (GDFT) strategy, when compared with a conventional fluid strategy, would better optimise systemic blood flow and lead to improved urethral tissue perfusion (a new variable to assess peripheral blood flow), without increasing blood loss. DESIGN: Single-centre prospective randomised controlled superiority study. SETTING: Erasme Hospital. PATIENTS: Patients undergoing liver surgery. INTERVENTION: Forty patients were randomised into two groups: all received a basal crystalloid infusion (maximum 2 ml kg-1 h-1). In the conventional fluid group, the goal was to maintain central venous pressure (CVP) as low as possible during the dissection phase by giving minimal additional fluid, while in the posttransection phase, anaesthetists were free to compensate for any presumed fluid deficit. In the GDFT group, patients received in addition to the basal infusion, multiple minifluid challenges of crystalloid to maintain stroke volume (SV) variation less than 13%. Noradrenaline infusion was titrated to keep mean arterial pressure more than 65 mmHg in all patients. MAIN OUTCOME MEASURE: The mean intra-operative urethral perfusion index. RESULTS: The mean urethral perfusion index was significantly higher in the GDFT group than in the conventional fluid group (8.70 [5.72 to 13.10] vs. 6.05 [4.95 to 8.75], P = 0.046). SV index (ml m-2) and cardiac index (l min-1 m-2) were higher in the GDFT group (48 ±â€Š9 vs. 33 ±â€Š7 and 3.5 ±â€Š0.7 vs. 2.4 ±â€Š0.4, respectively; P < 0.001). Although CVP was higher in the GDFT group (9.3 ±â€Š2.5 vs. 6.5 ±â€Š2.9 mmHg; P = 0.003), intra-operative blood loss was not significantly different in the two groups. CONCLUSION: In patients undergoing liver surgery, a GDFT strategy resulted in a higher mean urethral perfusion index than did a conventional fluid strategy and did not increase blood loss despite higher CVP. TRIAL REGISTRATION: NCT04092608.

Evaluation of a novel mobile phone application for blood pressure monitoring: a proof of concept study.

To provide information about the clinical relevance of blood pressure (BP) measurement differences between a new smartphone application (OptiBP™) and the reference method (automated oscillometric technique) using a noninvasive brachial cuff in patients admitted to the emergency department. We simultaneously recorded three BP measurements using both the reference method and the novel OptiBP™ (test method), except when the inter-arm difference was > 10 mmHg BP. Each OptiBP™ measurement required 1-min and the subsequent reference method values were compared to the values obtained with OptiBP™ using a Bland-Altman analysis and error grid analysis. Among the 110 patients recruited, OptiBP™ BP values could be collected on 61 patients (55%) and were included in the statistical analysis. The mean of differences (95% limits of agreement) between the reference method and the test method were - 0.1(- 22.5 to 22.4 mmHg) for systolic arterial pressure (SAP), - 0.1(- 12.9 to 12.7 mmHg) for diastolic arterial pressure (DAP) and - 0.3(- 18.1 to 17.4 mmHg) for mean arterial pressure (MAP). The proportions of measurements in risk zones A-E were 86.9%, 13.1%, 0%, 0%, and 0% for MAP and 89.3%, 10.7%, 0%, 0%, and 0% for SAP. In this pilot study conducted in stable and awake patients admitted to the emergency department, the absolute agreement between the OptiBP™ and the reference method was moderate. However, when BP measurements were made immediately after an initial calibration, error grid analysis showed that 100% of measurement differences between the OptiBP™ and reference method were categorized as no- or low-risk treatment decisions for all patients.Trial Registration: ClinicalTrials.gov Identifier: NCT04121624.

Evaluation of a new smartphone optical blood pressure application (OptiBP™) in the post-anesthesia care unit: a method comparison study against the non-invasive automatic oscillometric brachial cuff as the reference method.

We compared blood pressure (BP) values obtained with a new optical smartphone application (OptiBP™) with BP values obtained using a non-invasive automatic oscillometric brachial cuff (reference method) during the first 2 h of surveillance in a post-anesthesia care unit in patients after non-cardiac surgery. Three simultaneous BP measurements of both methods were recorded every 30 min over a 2-h period. The agreement between measurements was investigated using Bland-Altman and error grid analyses. We also evaluated the performance of the OptiBP™ using ISO81060-2:2018 standards which requires the mean of the differences ± standard deviation (SD) between both methods to be less than 5 mmHg ± 8 mmHg. Of 120 patients enrolled, 101 patients were included in the statistical analysis. The Bland-Altman analysis demonstrated a mean of the differences ± SD between the test and reference methods of + 1 mmHg ± 7 mmHg for mean arterial pressure (MAP), + 2 mmHg ± 11 mmHg for systolic arterial pressure (SAP), and + 1 mmHg ± 8 mmHg for diastolic arterial pressure (DAP). Error grid analysis showed that the proportions of measurement pairs in risk zones A to E were 90.3% (no risk), 9.7% (low risk), 0% (moderate risk), 0% (significant risk), 0% (dangerous risk) for MAP and 89.9%, 9.1%, 1%, 0%, 0% for SAP. We observed a good agreement between BP values obtained by the OptiBP™ system and BP values obtained with the reference method. The OptiBP™ system fulfilled the AAMI validation requirements for MAP and DAP and error grid analysis indicated that the vast majority of measurement pairs (≥ 99%) were in risk zones A and B.Trial Registration ClinicalTrials.gov Identifier: NCT04262323.

Automated closed-loop versus manually controlled norepinephrine infusion in patients undergoing intermediate- to high-risk abdominal surgery: a randomised controlled trial.

BACKGROUND: Hypotension occurs frequently during surgery and may be associated with adverse complications. Vasopressor titration is frequently used to correct hypotension, but requires considerable time and attention, potentially reducing the time available for other clinical duties. To overcome this issue, we have developed a closed-loop vasopressor (CLV) controller to help correct hypotension more efficiently. The aim of this randomised controlled study was to evaluate whether the CLV controller was superior to traditional vasopressor management at minimising hypotension in patients undergoing abdominal surgery. METHODS: Thirty patients scheduled for elective intermediate-to high-risk abdominal surgery were randomised into two groups. In the CLV group, hypotension was corrected automatically via the CLV controller system, which adjusted the rate of a norepinephrine infusion according to MAP values recorded using an advanced haemodynamic device. In the control group, management of hypotension consisted of standard, manual adjustment of the norepinephrine infusion. The primary outcome was the percentage of time that a patient was hypotensive, defined as MAP <90% of their baseline value, during surgery. RESULTS: The percentage of time patients were hypotensive during surgery was 10 times less in the CVL group than in the control group (1.6 [0.9-2.3]% vs 15.4 [9.9-24.3]%; difference: 13 [95% confidence interval: 9-19]; P<0.0001). The CVL group also spent much less time with MAP <65 mm Hg (0.2 [0.0-0.4]% vs 4.5 [1.1-7.9]%; P<0.0001). CONCLUSIONS: In patients undergoing intermediate- to high-risk surgery under general anaesthesia, computer-assisted adjustment of norepinephrine infusion significantly decreases the incidence of hypotension compared with manual control. CLINICAL TRIAL REGISTRATION: NCT04089644.