Tight intra-operative blood pressure control versus standard care for patients undergoing hip fracture repair - Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) trial: study protocol for a randomised controlled trial

Background: Hypotension during anaesthesia for hip fracture surgery is common. Recent data suggest that there is an association between the lowest intra-operative blood pressure and mortality, even when adjusted for co-morbidities. This is consistent with data derived from the wider surgical population, where magnitude and duration of hypotension are associated with mortality and peri-operative complications. However, there are no trial to data to support more aggressive blood pressure control. Methods/design: We are conducting a three-centre, randomised, double-blinded pilot study in three hospitals in the United Kingdom. The sample size will be 75 patients (25 from each centre). Randomisation will be done using computer-generated concealed tables. Both participants and investigators will be blinded to group allocation. Participants will be aged >70 years, cognitively intact (Abbreviated Mental Test Score 7 or greater), able to give informed consent and admitted directly through the emergency department with a fractured neck of the femur requiring operative repair. Patients randomised to tight blood pressure control or avoidance of intra-operative hypotension will receive active treatment as required to maintain both of the following: systolic arterial blood pressure >80% of baseline pre-operative value and mean arterial pressure >75 mmHg throughout. All participants will receive standard hospital care, including spinal or general anaesthesia, at the discretion of the clinical team. The primary outcome is a composite of the presence or absence of defined cardiovascular, renal and delirium morbidity within 7 days of surgery (myocardial injury, stroke, acute kidney injury, delirium). Secondary endpoints will include the defined individual morbidities, mortality, early mobility and discharge to usual residence. Discussion: This is a small-scale pilot study investigating the feasibility of a trial of tight intra-operative blood pressure control in a frail elderly patient group with known high morbidity and mortality. Positive findings will provide the basis for a larger-scale study

Does achieving the best practice tariff improve outcomes in hip fracture patients? An observational cohort study

Objectives: To determine if the introduction of the best practice tariff (BPT) has improved survival of the elderly hip fracture population, or if achieving BPT results in improved survival for an individual. Setting: A single university-affiliated teaching hospital. Participants: 2,541 patients aged over 60 admitted with a neck of femur fracture between 2008 and 2010 and from 2012 to 2014 were included, to create two cohorts of patients, before and after the introduction of BPT. The post-BPT cohort was divided into two groups, those who achieved the criteria and those who did not. Primary and Secondary Outcome Measures: Primary outcomes of interest were differences in mortality across cohorts. Secondary analysis was performed to identify associations between individual BPT criteria and mortality. Results: The introduction of BPT did not significantly alter overall 30-mortality in the hip fracture population (8.3% pre-BPT vs 10.0% post-BPT; p = 0.128). Neither was there a significant reduction in length of stay (15 days (IQR 9-21) pre-BPT vs 14 days (IQR 11-22); p=0.236). However, the introduction of BPT was associated with a reduction in the time from admission to theatre (median 44hours pre-BPT (IQR 24-44) vs 23hours post-BPT (IQR 17-30); p<0.005). 30-day mortality in those who achieved BPT was significantly lower (6.0% vs 21.0% in those who did not achieve-BPT; p < 0.005). There was a survival benefit at one year for those who achieved BPT (28.6% vs 42.0% did not achieve-BPT; p<0.005). Multivariate logistic regression revealed that of the BPT criteria, AMT monitoring and expedited surgery were the only BPT criteria that significantly influenced survival. Conclusion: The introduction of the BPT has not led to a demonstrable improvement in outcomes at organisational level, though other factors may have confounded any benefits. However, patients where BPT criteria are met appear to have improved outcomes

The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial

Background Anaemia following hip fracture is common. Approximately 30 to 45% of patients have haemoglobin concentrations below population norms on admission, and around 10% are severely anaemic. Anaemia on admission, and in the postoperative period, is associated with poor outcomes with regard to mobility, postoperative mortality and readmission. There is currently no clear consensus on the optimal method of managing perioperative anaemia in this group of frail patients with frequent comorbidity. Liberal red cell transfusion in the postoperative period does not appear to improve outcome, whereas tranexamic acid appears to reduce transfusion rate at the expense of increased cardiovascular morbidity. There are encouraging results from one centre with the use of agents to stimulate red cell production, including intravenous iron and erythropoietin. UK practice differs significantly from these patients and these studies, and it is not clear whether these promising results will translate to the UK population. Methods/Design This is a single-centre randomized controlled parallel group trial, in a British university hospital.Randomization is achieved using a website and computer-generated concealed tables. Participants are 80 patients 70 years or over with acute hip fracture undergoing operative repair. The intervention group receive three daily infusions of 200 mg iron sucrose, starting within 24 hours of admission. The control group receive standard hospital care at the discretion of the clinical team. Red cell transfusions for each group are given in accordance with standard clinical triggers. The primary outcome is an increase in mean reticulocyte count in the intervention group at day 7. Secondary outcome measures include haemoglobin concentrations, early and late transfusion rates, infectious and cardiovascular complications, mobility and 30-day mortality. Discussion This is a pilot study to demonstrate haematopoietic efficacy of intravenous iron in this setting. Hence, we have chosen to measure change in reticulocyte count rather than the more clinically relevant differences in haemoglobin concentration or transfusion rate. If our results are positive, the study will provide the necessary information for development of a full-scale trial of intravenous iron. Trial registration Current Controlled Trials ISRCTN76424792; UK Medicines and Healthcare products Regulatory Authority (EuDRACT: 2011-003233-34)

Optical coherence tomography in mild cognitive impairment – systematic review and meta-analysis

Thinning of retinal layers, measured using optical coherence tomography (OCT), is associated with some neurodegenerative disorders such as established Alzheimer’s disease and multiple sclerosis. The evidence for retinal layer thinning in both mild cognitive impairment (MCI), a precursor of dementia, and delirium, a potential pre-clinical stage of neurodegenerative disorder, is unclear. We performed a systematic review of the associations, in older people, between retinal layer thickness changes (measured using OCT) and delirium or MCI compared to controls (Protocol registration ID (Prospero) CRD42019122165). We did not identify any relevant studies on delirium. This report is therefore a review of retinal nerve layer changes in mild cognitive impairment. Databases were searched using predetermined keywords such as mild cognitive impairment, retinal nerve fibre layer and delirium. Where there were sufficient data, meta-analyses were performed. Twenty-six relevant studies were identified on retinal layer thickness in people with MCI compared to controls. There was significant heterogeneity in the studies for all retinal layers investigated (retinal nerve fibre layer (RNFL), ganglion cell inner plexiform layer (GCIP), foveal thickness and macular volume). Analysis of 17 studies of mean RNFL thickness in MCI (n = 622) compared to controls (n = 1154), irrespective of the type of OCT device, demonstrated a significant thinning in MCI (SMD: – 0·42 and 95% confidence interval: - 0·68 to - 0·16). This difference was non-significant when studies using only spectral-domain devices were analysed. Subgroup analysis of studies using spectral-domain devices in amnestic MCI diagnosed using comparable criteria, showed statistically significant thinning of RNFL in amnestic MCI (p = 0·02). Meta-analysis of foveal thickness did not show a significant difference between MCI and controls. In conclusion, there is some evidence of an association between retinal nerve fibre layer thinning and MCI. We found no data on the association between RNFL and delirium

Guidance in an uncertain world

In the face of the coronavirus pandemic, clinicians are looking to multiple sources for guidance. Good guidance provides a helpful tool to support decision making by experienced and highly-trained healthcare professionals. However, in the context of a readily changing landscape there are risks of guidance that hinders rather than helps, duplicates effort and fails to consider the front-line implications. Conversely, an overly conservative approach may result in good guidance never seeing the light of day, or being published too late. We suggest that there are key principles that may help guideline producers to improve the process. These include: addressing directly and transparently the competing risks and benefits to individual patients, staff and the wider community; making greater efforts to find reliable data to inform recommendations; ensuring duplication of effort and conflict with extant guidance is minimised; involving front-line staff in development and consideration of real-world implications of delivery; and ensuring that feedback and revisions are integral to the process. The MORAL Balance framework has previously been advocated for making complex individual patient level decision in critical care. We believe the same process can be appliedas a framework for guideline development groups

Anaesthesia workload measurement devices: qualitative systematic review

Background: Management of mental workload is a key aspect of safety in anaesthesia but there is no gold standard tool to assess mental workload, risking confusion in clinical and research use of such tools. Objective: This review assessed currently used mental workload assessment tools. Methods: A systematic literature search was performed on the following electronic databases; Cochrane, EMBASE, MEDLINE, SCOPUS and Web of Science. Screening and data extraction were performed individually by two authors. We included primary published papers focusing on mental workload assessment tools in anaesthesia. Results: A total of 2331 studies were screened by title, 32 at full text and twenty - four studies met the inclusion criteria. Six mental workload measurement tools were observed across included studies. Reliability for the Borg rating scales and Vibrotactile device were reported in two individual studies. The rest of the studies did not record reliability of the tool measurements used. Borg rating scales, NASA-TLX and task oriented mental work load measurements are subjective, easily available, readily accessible and takes a few minutes to complete. However, the Vibrotactile and Eye-tracking methods are objective, require more technical involvement, considerable time for the investigator, and moderately expensive, impacting their potential use. Conclusion: We found that, the measurement of mental workload in anaesthesia is an emerging field supporting patient and anaesthetist safety. The self - reported measures have the best evidence bas

Tight intra-operative blood pressure control versus standard care for patients undergoing hip fracture repair - Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) trial: study protocol for a randomised controlled trial

Background: Hypotension during anaesthesia for hip fracture surgery is common. Recent data suggest that there is an association between the lowest intra-operative blood pressure and mortality, even when adjusted for co-morbidities. This is consistent with data derived from the wider surgical population, where magnitude and duration of hypotension are associated with mortality and peri-operative complications. However, there are no trial to data to support more aggressive blood pressure control.Methods/design: We are conducting a three-centre, randomised, double-blinded pilot study in three hospitals in the United Kingdom. The sample size will be 75 patients (25 from each centre). Randomisation will be done using computer-generated concealed tables. Both participants and investigators will be blinded to group allocation. Participants will be aged >70 years, cognitively intact (Abbreviated Mental Test Score 7 or greater), able to give informed consent and admitted directly through the emergency department with a fractured neck of the femur requiring operative repair. Patients randomised to tight blood pressure control or avoidance of intra-operative hypotension will receive active treatment as required to maintain both of the following: systolic arterial blood pressure >80% of baseline pre-operative value and mean arterial pressure >75 mmHg throughout. All participants will receive standard hospital care, including spinal or general anaesthesia, at the discretion of the clinical team. The primary outcome is a composite of the presence or absence of defined cardiovascular, renal and delirium morbidity within 7 days of surgery (myocardial injury, stroke, acute kidney injury, delirium). Secondary endpoints will include the defined individual morbidities, mortality, early mobility and discharge to usual residence.Discussion: This is a small-scale pilot study investigating the feasibility of a trial of tight intra-operative blood pressure control in a frail elderly patient group with known high morbidity and mortality. Positive findings will provide the basis for a larger-scale study

Predicting 30-day mortality in patients with sepsis: an exploratory analysis of process of care and patient characteristics

Background Sepsis represents a significant public health burden, costing the NHS £2.5 billion annually, with 35% mortality in 2006. The aim of this exploratory study was to investigate risk factors predictive of 30-day mortality amongst patients with sepsis in Nottingham. Methods Data were collected prospectively from adult patients with sepsis in Nottingham University Hospitals NHS Trust as part of an on-going quality improvement project between November 2011 and March 2014. Patients admitted to critical care with the diagnosis of sepsis were included in the study. In all, 97 separate variables were investigated for their association with 30-day mortality. Variables included patient demographics, symptoms of systemic inflammatory response syndrome, organ dysfunction or tissue hypoperfusion, locations of early care, source of sepsis and time to interventions. Results A total of 455 patients were included in the study. Increased age (adjOR = 1.05 95%CI = 1.03–1.07 p < 0.001), thrombocytopenia (adjOR = 3.10 95%CI = 1.23–7.82 p = 0.016), hospital-acquired sepsis (adjOR = 3.34 95%CI = 1.78–6.27 p < 0.001), increased lactate concentration (adjOR = 1.16 95%CI = 1.06–1.27 p = 0.001), remaining hypotensive after vasopressors (adjOR = 3.89 95%CI = 1.26–11.95 p = 0.02) and mottling (adjOR = 3.80 95%CI = 1.06–13.55 p = 0.04) increased 30-day mortality odds. Conversely, fever (adjOR = 0.46 95%CI = 0.28-0.75 p = 0.002), fluid refractory hypotension (adjOR = 0.29 95%CI = 0.10–0.87 p = 0.027) and being diagnosed in surgical wards (adjOR = 0.35 95%CI = 0.15–0.81 p = 0.015) were protective. Treatment timeliness were not significant factors. Conclusion Several important predictors of 30-day mortality were found by this research. Retrospective analysis of our sepsis data has revealed mortality predictors that appear to be more patient-related than intervention-specific. With this information, care can be improved for those identified most at risk of death

Prediction of 30-day mortality after hip fracture surgery by the Nottingham Hip Fracture Score and the Surgical Outcome Risk Tool

The care of the elderly with hip fractures and their outcomes might be improved with resources targeted by the accurate calculation of risks of mortality and morbidity. We used a multicentre national dataset to evaluate and recalibrate the Nottingham Hip Fracture Score and Surgical Outcome Risk Tool. We split 9,017 hip fracture cases from the Anaesthesia Sprint Audit of Practice into derivation and validation data sets and used logistic regression to derive new model co-efficients for death at 30 postoperative days. The area (95% CI) under the receiver operator characteristic curve of 0.71 (0.67 0.75) indicated acceptable discrimination by the Nottingham Hip Fracture Score and acceptable calibration fit (Hosmer–Lemeshow test), p = 0.23, with a similar discrimination by the Surgical Outcome Risk Tool, 0.70 (0.66–0.74), which was miscalibrated to the observed data, p = 0.001. We recommend that studies test these scores for patients with hip fractures in other countries. We also recommend these models are compared with case-mix adjustment tools used in the UK

Femoral Nerve Block Intervention in Neck of Femur Fracture (FINOF): a randomized controlled trial

Objective Fractured neck of femur is a severely painful condition with significant mortality and morbidity. We investigated whether early and continuous use of femoral nerve block can improve pain on movement and mobility after surgery in older participants with fragility neck of femur fracture. Design Prospective single centre, randomised controlled pragmatic trial. Setting Secondary care, acute NHS Trust, UK. Participants Participants admitted with a history and examination suggesting fractured neck of femur. Intervention Immediate continuous femoral nerve block via catheter or standard analgesia. Results One hundred and forty one participants were recruited, with 23 excluded. No significant difference was detected between cumulative dynamic pain scores (standard care (n = 56) vs 4 intervention (n = 55) 20 (IQR 15-24) vs 20 (15-23) p=0.51) or cumulated ambulation scores (standard care vs intervention 6 (5-9) vs 7 (5-10) p=0.76). There were no statistically different differences in secondary outcomes except cumulative pain at rest: 5 (0.5-6.5) in the standard care group and 2 (0-5) in the intervention group (p=0.043). Conclusions Early application of continuous femoral nerve block compared with standard systemic analgesia did not result in improved dynamic pain scores or superior post-operative ambulation. This technique may provide superior pain relief at rest. Continuous femoral nerve block did not delay initial control of pain, or mobilisation after surgery