Critical Care - Research Publications
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ItemImpact of a policy to improve the management of oral medications when patients are fasting before a procedure: an interrupted time series analysis(BMJ PUBLISHING GROUP, 2022-05)BACKGROUND: Managing medications inappropriately when patients have oral intake restrictions can cause patient harm. This study evaluated the impact of a medication policy separating fasting from nil by mouth with respect to giving oral medications in patients fasting before a diagnostic or interventional procedure. METHODS: The policy stipulated that 'fasting' means oral medications should be given with a sip of water up to 1 hour before a procedure, unless there is a clinical reason to withhold, while 'nil by mouth' means nothing to be given orally, including medications.The policy was implemented in Surgical areas in February 2015 and Medical areas in March 2015 at a tertiary referral hospital in Melbourne, Australia, and included bedside signs, clinical champions and education sessions.The study was conducted in 2020. Admission and medication records were matched for non-elective procedure patients from January 2014 to May 2016. The monthly proportion of doses omitted inappropriately and overall omissions pre/post-policy implementation were compared using segmented regression. RESULTS: Pre-implementation, the proportion of doses withheld inappropriately and total omissions in medical areas were 18.1% and 28.0%, respectively. Post-implementation, an absolute reduction of 13.4% (95% CI 9.0% to 17.7%) and 11.1% (95% CI 2.6% to 19.6%), respectively, was seen. Post-implementation linear trend showed a 0.3% (95% CI 0.0% to 0.6%) increase in inappropriate omissions but not overall omissions.In Surgical areas, pre-implementation proportions for inappropriate and overall omissions were lower than Medical areas'. Post-implementation, there was an absolute decrease in doses withheld inappropriately (8.3%, 95% CI 0.8% to 15.7%, from 11.9% pre-implementation) but not total omissions. CONCLUSIONS: Distinguishing fasting from nil by mouth appeared to provide clarity for some staff: a reduction in inappropriate omissions was seen post-implementation. Although the small increase in post-implementation linear trend for inappropriate omissions in Medical areas suggests sustainability issues, total omissions were sustained. The policy's concepts require verification beyond our institution.
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ItemA protocol for prospective observational study to determine if non-anaemic iron deficiency worsens postoperative outcome in adult patients undergoing elective cardiac surgery: the IDOCS study(BMC, 2022-02-08)BACKGROUND: Pre-operative anaemia has been associated independently with worse outcomes after cardiac surgery in adults and is often caused by absolute or functional iron deficiency. Iron deficiency is a continuum ending with anaemia, and therefore it is plausible that pre-operative early or 'non-anaemic' iron deficiency may also be associated with worse outcomes in patients undergoing cardiac surgery. METHODS: We have designed a prospective, observational study to determine if there is an association between non-anaemic iron deficiency and worse outcomes after cardiac surgery in adults. Patients without anaemia undergoing elective cardiac surgery will be allocated to an iron-deficient and an iron-replete group based on standard pre-operative blood tests (ferritin, transferrin saturation and C-reactive protein). The primary outcome is days alive and at home on postoperative day 30. The key secondary outcomes are days alive and at home on postoperative day 90 and readmission to acute care. Other secondary outcomes include health-related quality of life questionnaires, quality of postoperative recovery, postoperative complications, changes in haemoglobin concentration, and requirement for allogeneic blood products. The planned study sample size is 240 patients per group, which has 83% power to detect a median difference of 1.25 days in the primary outcome. The study commenced in March 2018, and recently completed recruitment, with data audit and cleaning ongoing. DISCUSSION: This study will be conducted using a rigorous, prospective observational design; it will provide peak bodies and clinicians with high-quality evidence concerning the associations between non-anaemic iron deficiency and patient-centred outcomes after elective cardiac surgery. Our primary and key secondary outcomes are known to have great importance to clinicians and patients alike and align with the recommendations of the StEP-COMPAC group for outcomes in prospective peri-operative research. The definition used for iron deficiency accounts for both absolute and functional iron deficiency and make use of standard pre-operative blood tests to make this determination, easing the transition of results into clinical practice. The study will be conducted in two relatively high-volume centres in a single high-income country. This limits the generalisability of study results to similar centres. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ( ACTRN12618000185268 ). Registered 5 February 2018.
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ItemSugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial(BMC, 2021-11-09)BACKGROUND: Sugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex, neostigmine, and postoperative pulmonary complications. METHODS: Patients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong. Perioperative care was at the discretion of clinicians, except for the use of rocuronium and/or vecuronium for neuromuscular blockade and the randomised intervention (sugammadex or neostigmine) for reversal. Feasibility measurements included recruitment, crossover, acceptability, completeness, and workload. Trial coordinator feedback was systematically sought. Patient-reported quality of life was measured using the EQ-5D-5L score. The primary pilot outcome was the incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital). RESULTS: Among 150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86%). The randomised intervention was administered without crossover to 115 of 117 patients who received reversal (98%, 95% CI 94 to 100%). The protocol was acceptable or highly acceptable to the anaesthetist in 108 of 116 cases (93%, 95% CI 87 to 97%; missing = 4). Four patients of the 120 patients were lost to follow-up at 3 months (3.3%, 95% CI 0.9 to 8.3%). Case report forms were complete at 3 months for all remaining patients. The median time to complete trial processes was 3.5 h (range 2.5-4.5 h). Trial coordinators reported no barriers to trial processes. Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47%]). The primary outcome was observed in 5 (8.5%) of the 59 sugammadex patients and 5 (8.2%) of the 61 neostigmine patients (odds ratio 1.02, 95% CI 0.28 to 3.67). CONCLUSIONS: A large international randomised controlled trial of sugammadex, neostigmine and postoperative pulmonary complications in adult patients having abdominal and intrathoracic surgery, including collection of cost-effectiveness evidence for Health Technology Appraisal, is feasible. TRIAL REGISTRATION: Prospectively registered at the Australian and New Zealand Clinical Trials Registry ( ACTRN12620001313921 ) on December 7, 2020. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380645&isReview=true .
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ItemPostoperative outcomes following cardiac surgery in non-anaemic iron-replete and iron-deficient patients - an exploratory study(WILEY, 2018-04)Iron deficiency anaemia is strongly associated with poor outcomes after cardiac surgery. However, pre-operative non-anaemic iron deficiency (a probable anaemia precursor) has not been comprehensively examined in patients undergoing cardiac surgery, despite biological plausibility and evidence from other patient populations of negative effect on outcome. This exploratory retrospective cohort study aimed to compare an iron-deficient group of patients undergoing cardiac surgery with an iron-replete group. Consecutive non-anaemic patients undergoing elective coronary artery bypass grafting or single valve replacement in our institution between January 2013 and December 2015 were considered for inclusion. Data from a total of 277 patients were analysed, and were categorised by iron status and blood haemoglobin concentration into iron-deficient (n = 109) and iron-replete (n = 168) groups. Compared with the iron-replete group, patients in the iron-deficient group were more likely to be female (43% vs. 12%, iron-replete, respectively); older, mean (SD) age 64.4 (9.7) vs. 63.2 (10.3) years; and to have a higher pre-operative EuroSCORE (median IQR [range]) 3 (2-5 [0-10]) vs. 3 (2-4 [0-9]), with a lower preoperative haemoglobin of 141.6 (11.6) vs. 148.3 (11.7) g.l-1 . Univariate analysis suggested that iron-deficient patients had a longer hospital length of stay (7 (6-9 [2-40]) vs. 7 (5-8 [4-23]) days; p = 0.013) and fewer days alive and out of hospital at postoperative day 90 (83 (80-84 [0-87]) vs. 83 (81-85 [34-86]), p = 0.009). There was no evidence of an association between iron deficiency and either lower nadir haemoglobin or higher requirement for blood products during inpatient stay. After adjusting the model for pre-operative age, sex, renal function, EuroSCORE and haemoglobin, the mean increase in hospital length of stay in the iron-deficient group relative to the iron-replete group was 0.86 days (bootstrapped 95%CI -0.37 to 2.22, p = 0.098). This exploratory study suggests there is weak evidence of an association between non-anaemic iron deficiency and outcome after cardiac surgery after controlling for potentially confounding variables.
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ItemDevelopment of a Frailty Index from Routine Hospital Data in Perioperative and Critical Care(WILEY, 2020-12)BACKGROUND/OBJECTIVES: Frailty is common in surgical and intensive care unit (ICU) populations, yet it is not routinely measured. Frailty indices are able to quantify this condition across a range of health deficits. We aimed to develop a frailty index (FI) from routinely collected hospital data in a surgical and ICU population. DESIGN: Prospective observational single-center cohort study. SETTING: Tertiary referral metropolitan Australian hospital. PARTICIPANTS: A total of 336 individuals aged 65 and older undergoing surgery or aged 50 and older admitted to the ICU. MEASUREMENTS: Routine admission health data were used to derive an FI comprising 36 health deficits. We examined the FI correlation with existing frailty tools (Clinical Frailty Scale [CFS] and Edmonton Frail Scale [EFS]) and assessed its predictive ability for negative outcomes including 30-day mortality. RESULTS: Median FI was .17 (interquartile range [IQR]) = .10-.24) for ICU patients and .17 (IQR = .11-.25) for surgical patients; maximum FI was .58, and 25% (95% confidence interval [CI] = 10.4-29.6) of patients overall were diagnosed with frailty (FI score ≥.25). Correlation was strong between the FI and the EFS: ρ = .76 (95% CI = .70-.83) for ICU patients and .71 (95% CI = .64-.78) for surgical patients, and the CFS was .77 (95% CI = .70-.84) for ICU patients and .72 (95% CI = .65-.79) for surgical patients. The FI had good discriminative ability for prediction of 30-day mortality in ICU patients (multivariate odds ratio for each increase in FI of .1 = 2.04 [95% CI = 1.19-3.48]), comparable with the performance of the Acute Physiology and Chronic Health Evaluation III score (ICU patients) and the Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity score (surgical patients). CONCLUSION: It is feasible to construct an FI from hospital admission data in a cohort of critically ill and surgical patients.
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ItemChewing gum to treat postoperative nausea and emesis in female patients (CHEWY): rationale and design for a multicentre randomised trial(BMJ PUBLISHING GROUP, 2019-06)INTRODUCTION: Postoperative nausea, retching and vomiting (PONV) remains one of the most common side effects of general anaesthesia, contributing significantly to patient dissatisfaction, cost and complications. Chewing gum has potential as a novel, drug-free alternative treatment. We aim to conduct a large, definitive randomised controlled trial of the efficacy and safety of peppermint-flavoured chewing gum to treat PONV in the postanaesthesia care unit (PACU). If chewing gum is shown to be as effective as ondansetron, this trial has the potential to significantly improve outcomes for tens of millions of surgical patients around the world each year. METHODS AND ANALYSIS: This is a prospective, multicentre, randomised controlled non-inferiority trial. 272 female patients aged ≥12 years having volatile anaesthetic-based general anaesthesia for breast or laparoscopic surgery will be randomised. Patients experiencing nausea, retching or vomiting in PACU will be randomised to 15 min of chewing gum or 4 mg intravenous ondansetron. The primary outcome (complete response) is cessation of PONV within 2 hours of administration, with no recurrence nor rescue medication requirement for 2 hours after administration. ETHICS AND DISSEMINATION: The Chewy Trial has been approved by the Human Research Ethics Committees at all sites. Dissemination will be via international and national anaesthesia conferences, and publication in the peer-reviewed literature. TRIAL REGISTRATION NUMBER: ACTRN12618000429257; Pre-results.