Comparison of adequacy of anaesthesia monitoring with standard clinical practice monitoring during routine general anaesthesia: An international, multicentre, single-blinded randomised controlled trial.

BACKGROUND: Previous studies have suggested that monitoring the levels of both hypnosis and antinociception could reduce periods of inadequate anaesthesia. However, the evidence regarding associated benefits of this monitoring is still limited. OBJECTIVE: The primary objective of this study was to confirm that guidance of anaesthesia by depth of hypnosis and antinociception monitoring decreases the number of inadequate anaesthesia events in comparison with standard clinical practice. DESIGN: A multicentre, single-blinded, randomised controlled trial. SETTING: The study was conducted in four European University hospitals in four different countries between December 2013 and November 2016. PATIENTS: The study population consisted of a total of 494 adult patients undergoing elective surgery requiring tracheal intubation. INTERVENTIONS: The patients were allocated to one of two groups. The first group was treated using Entropy for depth of hypnosis and surgical pleth index to determine depth of antinociception (adequacy of anaesthesia group; AoA group). The second group was monitored using standard monitoring alone (control group). Anaesthesia was conducted with target-controlled infusions of propofol and remifentanil. MAIN OUTCOME MEASURES: The primary outcome of the study was the number of total unwanted events for example signs of inadequately light or unintentionally deep anaesthesia. RESULTS: Evidence of inadequate anaesthesia had an incidence of around 0.7 events per patient in both groups with no difference between groups (P = 0.519). In the AoA group, the overall consumption of propofol was significantly reduced (6.9 vs. 7.5 mg kg h, P = 0.008) in comparison with the control group. The consumption of remifentanil was equal in both groups. The times to emergence [8.0 vs. 9.6 min (P = 0.005)] and full recovery in the postanaesthesia care unit (P = 0.043) were significantly shorter in the AoA group. No differences were seen in postoperative pain scores or in the use of analgesics. CONCLUSION: In the current study, the guidance of total intravenous anaesthesia by Entropy and surgical pleth index in comparison with standard monitoring alone was not able to validate reduction of unwanted anaesthesia events. However, there was a reduction in the use of propofol, and shorter times for emergence and time spent in the postanaesthesia care unit. TRIAL REGISTRATION: at ClinicalTrials.gov NCT01928875.

The effectiveness of a low-dose esketamine versus an alfentanil adjunct to propofol sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled multicentre trial.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most complex gastrointestinal endoscopic procedures. Currently, it is still unclear which sedation regimen best facilitates an ERCP. The N-methyl-D-aspartate receptor antagonist esketamine has anaesthetic, analgesic and sympathomimetic properties and is known to cause less cardiorespiratory depression than other sedatives. It could therefore be an ideal adjunct to propofol for deep sedation. OBJECTIVE: To assess the effectiveness of esketamine versus alfentanil as an adjunct to propofol target-controlled infusion (TCI) for deep sedation during ambulant ERCP. DESIGN: A randomised controlled multicentre study. SETTING: Endoscopic intervention suite at an academic and general hospital in the Netherlands. PARTICIPANTS: Adult, American Society of Anesthesiologists Physical Status I to III patients scheduled to undergo ERCP. INTERVENTION: Consecutive patients were randomly assigned to receive sedation for an ERCP with propofol TCI and alfentanil (group A) or with propofol TCI and esketamine (group E). MAIN OUTCOME MEASURES: The primary outcome was effectiveness of the sedation regimen expressed as the total dose of propofol - as a surrogate parameter - necessary to perform ERCP in a satisfactory manner for endoscopist and patients. Secondary outcomes were recovery time, patients' and endoscopists' satisfaction with sedation, side effects (e.g. psychotomimetic effects, nausea and vomiting) and the number of respiratory and cardiovascular adverse events. RESULTS: Data from 162 patients were analysed. The total dose of propofol required was significantly lower in group E (n=83) (8.3 mg kg h) than in group A (n=79) (10.5 mg kg h) (P < 0.001). There were no significant differences in recovery time, patients' and endoscopists' satisfaction, side effects, psychotomimetic effects and the number of sedation-related adverse events. CONCLUSION: Low-dose esketamine reduces the total amount of propofol necessary for sedation during ERCP in American Society of Anesthesiologists I and II patients without affecting recovery time, satisfaction of patients and endoscopists, side effects and respiratory or cardiovascular adverse events, when compared with alfentanil. TRIAL REGISTRATION: The Netherlands Trial Register (NTR5486).

The emergency paediatric surgical airway: A systematic review.

BACKGROUND: Although an emergency surgical airway is recommended in the guidelines for a paediatric cannot intubate, cannot oxygenate (CICO), there is currently no evidence regarding the best technique for this procedure. OBJECTIVE: To review the available literature on the paediatric emergency surgical airway to give recommendations for establishing a best practice for this procedure. DESIGN: Systematic review: Considering the nature of the original studies, a meta-analysis was not possible. DATA SOURCES: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Web of Science, Google Scholar and LILACS databases. ELIGIBILITY CRITERIA: Studies addressing the paediatric emergency surgical airway and reporting the following outcomes: time to tracheal access, success rate, complications and perceived ease of use of the technique were included. Data were reported using a Strengths, Weaknesses, Opportunities and Threats analysis. Strengths and Weaknesses describe the intrinsic (dis)advantages of the techniques. The opportunities and threats describe the (dis)advantage of the techniques in the setting of a paediatric CICO scenario. RESULTS: Five studies described four techniques: catheter over needle, wire-guided, cannula or scalpel technique. Mean time for placement of a definitive airway was 44 s for catheter over needle, 67.3 s for the cannula and 108.7 s for the scalpel technique. No time was reported for the wire-guided technique. Success rates were 43 (10/23), 100 (16/16), 56 (87/154) and 88% (51/58), respectively. Complication rates were 34 (3/10), 69 (11/16), 36 (55/151) and 38% (18/48), respectively. Analysis shows: catheter over needle, quick but with a high failure rate; wire-guided, high success rate but high complication rate; cannula, less complications but high failure rate; scalpel, high success rate but longer procedural time. The available data are limited and heterogeneous in terms of reported studies; thus, these results need to be interpreted with caution. CONCLUSION: The absence of best practice evidence necessitates further studies to provide a clear advice on best practice management for the paediatric emergency surgical airway in the CICO scenario.

Safety of moderate-to-deep sedation performed by sedation practitioners: A national prospective observational study.

BACKGROUND: In the Netherlands, a significant proportion of moderate-to-deep sedation is performed by sedation practitioners under the indirect supervision of an anaesthesiologist but there are limited safety data available. OBJECTIVE: To estimate the rate of sedation-related adverse events and patient relevant outcomes (PRO). DESIGN: This was a prospective national observational study. Data were collected with a modified adverse event reporting tool from the International Sedation Task Force of the World Society of Intravenous Anaesthesia. SETTING: A total of 24 hospitals in the Netherlands where moderate-to-deep sedation was performed by sedation practitioners from the 1 February 2015 to 1 March 2016. PATIENTS: Consecutive adults undergoing moderate-to-deep sedation for gastrointestinal, pulmonary and cardiac procedures. INTERVENTION: Observation: Analysis included descriptive statistics and a multivariate logistic regression model for an association between adverse events and PRO. MAIN OUTCOME MEASURES: The primary outcome was the rate of unfavourable PRO (admission to ICU, permanent neurological deficit, pulmonary aspiration or death). Secondary outcome was the rate of moderate-to-good PRO (unplanned hospital admission or escalation of care). Composite outcome was the sum of all primary and secondary outcomes. RESULTS: A total of 11 869 patients with a median age of 64 years [interquartile range 51 to 72] were included. ASA physical score distribution was: first, 19.1%; second, 57.6%; third, 21.6%; fourth, 1.2%. Minimal adverse events occurred in 1517 (12.8%), minor adverse events in 113 (1.0%) and major adverse events in 80 instances (0.7%). PRIMARY OUTCOME: Five (0.04%) unfavourable PRO were observed; four patients needing admission to the intensive care unit; and one died. Secondary outcome: 12 (0.1%) moderate-to-good PRO were observed. Moderate and major adverse events were associated with the composite outcome [3.7 (95% confidence interval 1.1 to 11.9) and 40.6 (95% confidence interval 11.0 to 150.4)], but not minimal or minor adverse events. CONCLUSION: Moderate-to-deep sedation performed by trained sedation practitioners has a very low rate of unfavourable outcome.

The horizon of pediatric cardiac critical care.

Pediatric Cardiac Critical Care (PCCC) is a challenging discipline where decisions require a high degree of preparation and clinical expertise. In the modern era, outcomes of neonates and children with congenital heart defects have dramatically improved, largely by transformative technologies and an expanding collection of pharmacotherapies. Exponential advances in science and technology are occurring at a breathtaking rate, and applying these advances to the PCCC patient is essential to further advancing the science and practice of the field. In this article, we identified and elaborate on seven key elements within the PCCC that will pave the way for the future.

Effect of Cognitive Aids on Adherence to Best Practice in the Treatment of Deteriorating Surgical Patients: A Randomized Clinical Trial in a Simulation Setting.

Importance: Failure to rescue causes significant morbidity and mortality in the surgical population. Human error is often the underlying cause of failure to rescue. Human error can be reduced by the use of cognitive aids. Objectives: To test the effectiveness of cognitive aids on adherence to best practice in the management of deteriorating postoperative surgical ward patients. Design, Setting, and Participants: Randomized clinical trial in a simulation setting. Surgical teams consisted of 1 surgeon and 2 nurses from a surgical ward from 4 different hospitals in Amsterdam, the Netherlands. Data were analyzed between February 2, 2017, and December 18, 2018. Interventions: The teams were randomized to manage 3 simulated deteriorating patient scenarios with or without the use of cognitive aids. Main Outcomes and Measures: The primary outcome of the study was failure to adhere to best practice, expressed as the percentage of omitted critical management steps. The secondary outcome of the study was the perceived usability of the cognitive aids. Results: Of the total participants, 93 were women and 51 were men. Twenty-five surgical teams performed 75 patient scenarios with cognitive aids, and 25 teams performed 75 patient scenarios without cognitive aids. Using the cognitive aids resulted in a reduction of omitted critical management steps from 33% to 10%, which is a 70% (P < .001) reduction. This effect remained significant (odds ratio, 0.63; 95% CI, -0.228 to -0.061; P = .001) in a multivariate analysis. Overall usability (scale of 0-10) of the cognitive aids was scored at a median of 8.7 (interquartile range, 8-9). Conclusions and Relevance: Failure to comply with best practice management of postoperative complications is associated with worse outcomes. In this simulation study, adherence to best practice in the management of postoperative complications improves significantly by the use of cognitive aids. Cognitive aids for deteriorating surgical patients therefore have the potential to reduce failure to rescue and improve patient outcome. Trial Registration: ClinicalTrials.gov identifier: NCT03812861.

Cognitive aids: 'a must' for procedures performed by multidisciplinary sedation teams outside the operation room?

The human brain might not perform optimally during stressful situations. Cognitive aids can help in such situations to carry out all necessary treatment steps in a correct order. We present the case of a severe anaphylactic reaction during a percutaneous radiological intervention to drain an echinococcosis cyst on the radiology suite outside the operation room (OR), in which cognitive aids were successfully used to optimise patient care by a multidisciplinary team. Cognitive aids do not replace experience and skills of the individual caregivers, but can be invaluable tools for multidisciplinary teams dealing with crisis situations outside the OR.

Sedation with propofol during ERCP: is the combination with esketamine more effective and safer than with alfentanil? Study protocol for a randomized controlled trial.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is a gastrointestinal procedure that requires a relatively motionless patient during the intervention. Deep sedation by intravenous propofol combined with an opioid has recently become the preferred sedation technique. However, when high doses of propofol are used, side effects, namely respiratory depression, may occur. Esketamine has hypnotic, analgesic, and sympathomimetic effects. Our assumption is that a combination of propofol with esketamine reduces the dosage of individual drugs, thereby minimizing sedation side effects while keeping the same satisfaction level of patients and endoscopists. METHODS/DESIGN: The study will be performed as a randomized controlled multicenter trial. Patients undergoing ERCP, ≥ 18 years old, with American Society of Anesthesiologists (ASA) classification I-III will be randomized after written informed consent to group K (propofol/esketamine) or to group A (propofol/alfentanil). The primary outcome, reflecting effectiveness of sedation, is the total dose of propofol. Secondary outcome parameters are patients' and endoscopists' satisfaction with the procedure and the number of sedation-related pulmonary and cardiovascular events. Data on sedation-related events are collected by recording of oxygen saturation (SpO2), respiratory rate (RR), end-tidal CO2 (etCO2), heart rate (HR), arrhythmias (electrocardiogram (ECG)), and non-invasive blood pressure (NIBP) measurements. Satisfaction parameters are collected by means of questionnaires before and after the procedure and on the following day. DISCUSSION: Esketamine is known for its effective anesthetic and analgesic effects maintaining spontaneous breathing and airway reflexes. Due to an increase in sympathetic tone, hypotension and cardiac depression is less common. Unfortunately esketamine is also known for its psychotomimetic effects. We aim to demonstrate that the combination of esketamine with propofol for sedation in patients subjected to ERCP interventions is nevertheless superior to a combination of propofol with an opioid. TRIAL REGISTRATION: Nederland's Trial Register, NTR5486 . Registered on 17 September 2015.

European implementation of the "2014 ESC/ESA guideline on non-cardiac surgery: cardiovascular assessment and management".

BACKGROUND: Substandard implementation of a guideline is a major factor contributing to poor guideline adherence and has the potential to result in preventable patient harm. This study aims to quantify the uptake of the European guideline on non-cardiac surgery by European anesthetists. METHODS: This is a questionnaire-based cross-sectional study. Data was collected during Euroanaesthesia, the annual congresses of the Dutch Society of Anaesthesiology, European Association of Cardiothoracic Anaesthesiologists and European Society for Regional Anaesthesia and Pain Therapy in 2015. Primary endpoints were the implementation and knowledge scores derived from the questionnaires. RESULTS: The implementation score from 488 questionnaires was excellent in 4%, good in 14%, average in 22%, poor in 32% and very poor in 28% of the cases. The knowledge score was excellent in 1%, good in 27%, moderate in 49%, poor in 18% and very poor in 5% of the cases. CONCLUSIONS: Current implementation and knowledge of the guideline on non-cardiac surgery in Europe needs to be improved.

[Cognitive aid for emergencies in the OR--AMC bundle helps ensure that no steps are left out]. / Cognitieve leidraad voor noodgevallen op de OK--AMC-bundel helpt om geen stappen te vergeten.

Crucial management steps in unexpected perioperative emergencies are frequently omitted by OR teams because of the suboptimal performance of the brain under stress.A cognitive aid is a tool that will help care providers to perform and speed up all the necessary management steps of a critical event. We have created a Dutch adaption of the Stanford Emergency Manual, a bundle of cognitive aids to manage a number of life threatening emergencies in the operating theatre. The effectiveness of these cognitive aids has been demonstrated in simulated emergencies. Their use has furthermore, been standard practice in other high-risk industries for many years. Further research should therefore mainly focus on the implementation and optimisation of these tools.

Establishing a regional enterocutaneous fistula service: the Royal London hospital experience.

BACKGROUND: The development of enterocutaneous fistula (ECF) is one of the most challenging complications encountered in colorectal surgery. Currently, only two supra-regional centres are nationally designated in the United Kingdom to treat ECF patients. The aim of this study was to assess clinical outcome measures following the implementation of an ECF service at The Royal London Hospital. METHODS: All patients diagnosed with enterocutaneous fistula between December 2005 and November 2011 were recruited to the study. Clinical outcomes analysed included successful ECF closure, number of surgical procedures required for successful ECF closure, re-fistulation rates and morbidity/mortality data. RESULTS: 41 patients (20 M:21 F) of median age 54 years (range, 16-81) were studied. Patients had undergone a median of 4 (range, 1-18) operations prior to referral. Eleven fistulas (27%) healed spontaneously. Of the remaining 30 patients, 5 (17%) died before surgery due to uncontrollable sepsis and 6 (20%) refused surgical intervention and were managed conservatively. Nineteen patients (63%) underwent definitive surgical repair requiring a median of 1 (range, 1-2) operations, with recurrent fistulation reported in 4 patients (21%). No intra-operative mortality was encountered. Two (11%) patients died postoperatively due to cardio-respiratory complications. CONCLUSIONS: These data compare favourably with outcome measures reported by designated national centres, suggesting ECF patients can be safely managed closer to home in regional units that have the appropriate expertise. Nevertheless, management of this condition remains critically dependent upon a dedicated multidisciplinary team approach.