Challenges With Continuous Pulse Oximetry Monitoring and Wireless Clinician Notification Systems After Surgery: Reactive Analysis of a Randomized Controlled Trial.

BACKGROUND: Research has shown that introducing electronic Health (eHealth) patient monitoring interventions can improve healthcare efficiency and clinical outcomes. The VIGILANCE (VItal siGns monItoring with continuous puLse oximetry And wireless cliNiCian notification aftEr surgery) study was a randomized controlled trial (n=2049) designed to assess the impact of continuous vital sign monitoring with alerts sent to nursing staff when respiratory resuscitations with naloxone, code blues, and intensive care unit transfers occurred in a cohort of postsurgical patients in a ward setting. This report identifies and evaluates key issues and challenges associated with introducing wireless monitoring systems into complex hospital infrastructure during the VIGILANCE eHealth intervention implementation. Potential solutions and suggestions for future implementation research are presented. OBJECTIVE: The goals of this study were to: (1) identify issues related to the deployment of the eHealth intervention system of the VIGILANCE study; and (2) evaluate the influence of these issues on intervention adoption. METHODS: During the VIGILANCE study, issues affecting the implementation of the eHealth intervention were documented on case report forms, alarm event forms, and a nursing user feedback questionnaire. These data were collated by the research and nursing personnel and submitted to the research coordinator. In this evaluation report, the clinical adoption framework was used as a guide to organize the identified issues and evaluate their impact. RESULTS: Using the clinical adoption framework, we identified issues within the framework dimensions of people, organization, and implementation at the meso level, as well as standards and funding issues at the macro level. Key issues included: nursing workflow changes with blank alarm forms (24/1030, 2.33%) and missing alarm forms (236/1030, 22.91%), patient withdrawal (110/1030, 10.68%), wireless network connectivity, false alarms (318/1030, 30.87%), monitor malfunction (36/1030, 3.49%), probe issues (16/1030, 1.55%), and wireless network standards. At the micro level, these issues affected the quality of the service in terms of support provided, the quality of the information yielded by the monitors, and the functionality, reliability, and performance of the monitoring system. As a result, these issues impacted access through the decreased ability of nurses to make complete use of the monitors, impacted care quality of the trial intervention through decreased effectiveness, and impacted productivity through interference in the coordination of care, thus decreasing clinical adoption of the monitoring system. CONCLUSIONS: Patient monitoring with eHealth technology in surgical wards has the potential to improve patient outcomes. However, proper planning that includes engagement of front-line nurses, installation of appropriate wireless network infrastructure, and use of comfortable cableless devices is required to maximize the potential of eHealth monitoring. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907255; https://clinicaltrials.gov/ct2/show/NCT02907255.

Vital sign monitoring with continuous pulse oximetry and wireless clinical notification after surgery (the VIGILANCE pilot study)-a randomized controlled pilot trial.

BACKGROUND: Respiratory depression is a serious perioperative complication associated with morbidity and mortality. Recently, technology has become available to wirelessly monitor patients on regular surgical wards with continuous pulse oximetry and wireless clinician notification with alarms. When a patient's SpO2 falls below a set threshold, the clinician is notified via a pager and may intervene earlier to prevent further clinical deterioration. To date, the technology has not been evaluated with a randomized controlled trial (RCT). METHODS: We designed a parallel-group unblinded pilot RCT of a wireless monitoring system on two surgical wards in an academic teaching hospital. Postsurgical patients with an anticipated length of stay of at least 1 day were included and randomized to standard care or standard care plus wireless respiratory monitoring for up to a 72-h period. The primary outcomes were feasibility outcomes: average patients recruited per week and tolerability of the system by patients. Secondary outcomes included (1) respiratory events (naloxone administration for respiratory depression, ICU transfers, and cardiac arrest team activation) and (2) system alarm types and details. The analysis of the outcomes was based on descriptive statistics and estimates reported using point (95% confidence intervals). Criteria for success of feasibility were recruitment of an average of 15 patients/week and 90% of the patients tolerating the system. RESULTS: The pilot trial enrolled 250 of the 335 patients screened for eligibility, with 126 and 124 patients entering the standard monitoring and wireless groups, respectively. Baseline demographics were similar between groups, except for slightly more women in the wireless group. Average patient recruitment per week was 14 95% CI [12, 16] patients. The wireless monitoring was quite tolerable with 86.6% (95% CI 78.2-92.7%) of patients completing the full course, and there were no other adverse events directly attributable to the monitoring. With regard to secondary outcomes, the respiratory event rate was low with only 1 event in the wireless group and none in the control group. The average number of alarms per week was 4.0 (95% CI, 1.6-6.4). CONCLUSIONS: This pilot study demonstrated adequate patient recruitment and high tolerability of the wireless monitoring system. A full RCT that is powered to detect patient important outcomes such as respiratory depression is now underway. TRIAL REGISTRATION: ClinicalTrials.gov, Registration number NCT02907255, registered 7 September 2016-retrospectively registered.

Dexamethasone as an Adjuvant for Caudal Blockade in Pediatric Surgical Patients: A Systematic Review and Meta-analysis.

BACKGROUND: Caudal block is commonly used to provide postoperative analgesia after pediatric surgery in the lower abdomen. Typically administered as a single-shot technique, 1 limitation of this block is the short duration of analgesia. To overcome this, dexamethasone has been used as an adjuvant to prolong block duration. However, there are concerns about steroid-related morbidity and the optimal route of dexamethasone administration (eg, caudal or intravenous) is unknown. METHODS: We conducted a systematic review and random-effects meta-analysis of randomized controlled trials recruiting pediatric surgical patients receiving a caudal block for surgical anesthesia or postoperative analgesia. Included studies compared dexamethasone (caudal, intravenous, or both) to control. Duration of analgesia was the primary outcome. Database sources were Medline, Embase, the Cochrane Library, and Google Scholar searched up to August 18, 2017, without language restriction. Screening of studies, data extraction, and risk of bias assessment were performed independently and in duplicate by 2 authors. Risk of bias was assessed using Cochrane methodology and the strength of evidence was scored using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. RESULTS: The initial search retrieved 93 articles. Fourteen randomized controlled trials that comprised 1315 pediatric patients met the inclusion criteria. All but 1 study involved lower abdominal operations (orchidopexy, inguinal hernia repair, and hypospadias repair). The caudal and intravenous dose of dexamethasone ranged from 0.1 to 0.2 mg/kg and 0.5 to 1.5 mg/kg, respectively, and all studies were pooled in the main analysis. Dexamethasone prolonged the duration of analgesia by both the caudal route (5.43 hours, 95% confidence interval [CI], 3.52-7.35; P < .001; I = 99.3%; N = 9; n = 620; GRADE quality = moderate) and intravenous route (5.51 hours; 95% CI, 3.56-7.46; P < .001; I = 98.9%; N = 5; n = 364; GRADE quality = moderate) versus control. Secondary benefits of dexamethasone included reduced narcotic rescue analgesia requirement in the postanesthetic care unit (relative risk [RR], 0.30; 95% CI, 0.18-0.51; P < .001; I = 0.0%; N = 5; number needed to treat for benefit [NNTB] = 5; 95% CI, 4-7), less subsequent postoperative rescue analgesia requirement (RR, 0.46; 95% CI, 0.23-0.92; P = .03; I = 96.0%; N = 9; n = 629; NNTB = 3; 95% CI, 2-20; n = 310), and lower rates of postoperative nausea and vomiting (RR, 0.47; 95% CI, 0.30-0.73; P = .001; I = 0.0%; NNTB = 11; 95% CI, 8-21; N = 9; n = 628). Adverse events linked to the dexamethasone were rare. CONCLUSIONS: Caudal and intravenous dexamethasone are similarly effective for prolonging the duration of analgesia from caudal blockade, resulting in a doubled to tripled duration. Given the off-label status of caudal dexamethasone, intravenous administration is recommended-although only high intravenous doses (0.5 mg/kg up to 10 mg) have been studied.

Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis.

BACKGROUND: Much uncertainty exists as to whether peri-operative goal-directed therapy is of benefit. OBJECTIVES: To discover if peri-operative goal-directed therapy decreases mortality and morbidity in adult surgical patients. DESIGN: An updated systematic review and random effects meta-analysis of randomised controlled trials. DATA SOURCES: Medline, Embase and the Cochrane Library were searched up to 31 December 2016. ELIGIBILITY CRITERIA: Randomised controlled trials enrolling adult surgical patients allocated to receive goal-directed therapy or standard care were eligible for inclusion. Trauma patients and parturients were excluded. Goal-directed therapy was defined as fluid and/or vasopressor therapy titrated to haemodynamic goals [e.g. cardiac output (CO)]. Outcomes included mortality, morbidity and hospital length of stay. Risk of bias was assessed using Cochrane methodology. RESULTS: Ninety-five randomised trials (11 659 patients) were included. Only four studies were at low risk of bias. Modern goal-directed therapy reduced mortality compared with standard care [odds ratio (OR) 0.66; 95% confidence interval (CI) 0.50 to 0.87; number needed to treat = 59; N = 52; I = 0.0%]. In subgroup analysis, there was no mortality benefit for fluid-only goal-directed therapy, cardiac surgery patients or nonelective surgery. Contemporary goal-directed therapy also reduced pneumonia (OR 0.69; 95% CI, 0.51 to 0. 92; number needed to treat = 38), acute kidney injury (OR 0. 73; 95% CI, 0.58 to 0.92; number needed to treat = 29), wound infection (OR 0.48; 95% CI, 0.37 to 0.63; number needed to treat = 19) and hospital length of stay (days) (-0.90; 95% CI, -1.32 to -0.48; I = 81. 2%). No important differences in outcomes were found for the pulmonary artery catheter studies, after accounting for advances in the standard of care. CONCLUSION: Peri-operative modern goal-directed therapy reduces morbidity and mortality. Importantly, the quality of evidence was low to very low (e.g. Grading of Recommendations, Assessment, Development and Evaluation scoring), and there was much clinical heterogeneity among the goal-directed therapy devices and protocols. Additional well designed and adequately powered trials on peri-operative goal-directed therapy are necessary.

Should Transfusion Trigger Thresholds Differ for Critical Care Versus Perioperative Patients? A Meta-Analysis of Randomized Trials.

OBJECTIVE: To address the significant uncertainty as to whether transfusion thresholds for critical care versus surgical patients should differ. DESIGN: Meta-analysis of randomized controlled trials. SETTING: Medline, EMBASE, and Cochrane Library searches were performed up to 15 June 2016. PATIENTS: Trials had to enroll adult surgical or critically ill patients for inclusion. INTERVENTIONS: Studies had to compare a liberal versus restrictive threshold for the transfusion of allogeneic packed RBCs. MEASUREMENTS AND MAIN RESULTS: The primary outcome was 30-day all-cause mortality, sub-grouped by surgical and critical care patients. Secondary outcomes included myocardial infarction, stroke, renal failure, allogeneic blood exposure, and length of stay. Odds ratios and weighted mean differences were calculated using random effects meta-analysis. To assess whether subgroups were significantly different, tests for subgroup interaction were used. Subgroup analysis by trials enrolling critically ill versus surgical patients was performed. Twenty-seven randomized controlled trials (10,797 patients) were included. In critical care patients, restrictive transfusion resulted in significantly reduced 30-day mortality compared with liberal transfusion (odds ratio, 0.82; 95% CI, 0.70-0.97). In surgical patients, a restrictive transfusion strategy led to the opposite direction of effect for mortality (odds ratio, 1.31; 95% CI, 0.94-1.82). The subgroup interaction test was significant (p = 0.04), suggesting that the effect of restrictive transfusion on mortality is statistically different for critical care (decreased risk) versus surgical patients (potentially increased risk or no difference). Regarding secondary outcomes, for critically ill patients, a restrictive strategy resulted in reduced risk of stroke/transient ischemic attack, packed RBC exposure, transfusion reactions, and hospital length of stay. In surgical patients, restrictive transfusion resulted in reduced packed RBC exposure. CONCLUSIONS: The safety of restrictive transfusion strategies likely differs for critically ill patients versus perioperative patients. Further trials investigating transfusion strategies in the perioperative setting are necessary.

Programmed intermittent peripheral nerve local anesthetic bolus compared with continuous infusions for postoperative analgesia: A systematic review and meta-analysis.

STUDY OBJECTIVE AND BACKGROUND: The role of the programmed intermittent bolus (PIB) technique for infusion of local anesthetics in continuous peripheral nerve blockade (CPNB) remains to be elucidated. Randomized controlled trials (RCTs) on PIB versus continuous infusion for CPNB have demonstrated conflicting results and no systematic review or meta-analysis currently exists. We aimed to delineate via systematic review with meta-analysis if there is any analgesic benefit to performing PIB versus continuous infusion for CPNB. DESIGN: We conducted a systematic review and random-effects meta-analysis of RCTs. DATA SOURCES: We searched Medline, Embase, and the Cochrane Library without language restriction from inception to 2-May-2017. ELIGIBILITY CRITERIA: Included RCTs had to compare PIB to continuous infusion in adult surgical patients receiving any upper or lower limb CPNB for postoperative analgesia. VAS pain scores were the primary outcome. The Cochrane Risk of Bias Tool with GRADE methodology was utilized to assess evidence quality. RESULTS: Nine RCTs (448 patients) met the inclusion criteria. Two studies performed upper limb blocks and the rest lower limb blocks. Five RCTs activated the CPNB with long-acting local anesthetic and only five used multi-modal analgesia. PIB modestly reduced VAS pain scores at 6h (-14.2mm; 95%CI -23.5mm to -5.0mm; I2=82.5%; p=0.003) and 12h (-9.9mm; 95%CI -14.4mm to -5.4mm; I2=12.4%; p<0.001), but not at later time points. There were no other meaningful differences in the rest of the outcomes, apart from more residual motor block with PIB (OR 4.27; 95% CI 1.08-16.9; p=0.04; NNTH=8). GRADE scoring ranged from low to very low. CONCLUSIONS: The existing evidence demonstrates that PIB does not meaningfully reduce VAS pain scores in CPNB. This systematic review provides important information about the limitations of existing studies. Future studies should reflect contemporary practice and focus on more painful operations.

Small-molecule modulators of Listeria monocytogenes biofilm development.

Listeria monocytogenes is an important food-borne pathogen whose ability to form disinfectant-tolerant biofilms on a variety of surfaces presents a food safety challenge for manufacturers of ready-to-eat products. We developed here a high-throughput biofilm assay for L. monocytogenes and, as a proof of principle, used it to screen an 80-compound protein kinase inhibitor library to identify molecules that perturb biofilm development. The screen yielded molecules toxic to multiple strains of Listeria at micromolar concentrations, as well as molecules that decreased (≤ 50% of vehicle control) or increased (≥ 200%) biofilm formation in a dose-dependent manner without affecting planktonic cell density. Toxic molecules-including the protein kinase C antagonist sphingosine-had antibiofilm activity at sub-MIC concentrations. Structure-activity studies of the biofilm inhibitory compound palmitoyl-d,l-carnitine showed that while Listeria biofilm formation was inhibited with a 50% inhibitory concentration of 5.85 ± 0.24 µM, d,l-carnitine had no effect, whereas palmitic acid had stimulatory effects. Saturated fatty acids between C(9:0) and C(14:0) were Listeria biofilm inhibitors, whereas fatty acids of C(16:0) or longer were stimulators, showing chain length specificity. De novo-synthesized short-chain acyl carnitines were less effective biofilm inhibitors than the palmitoyl forms. These molecules, whose activities against bacteria have not been previously established, are both useful probes of L. monocytogenes biology and promising leads for the further development of antibiofilm strategies.