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    Postoperative systemic inflammation after major abdominal surgery: patient-centred outcomes.
    Bain, CR ; Myles, PS ; Martin, C ; Wallace, S ; Shulman, MA ; Corcoran, T ; Bellomo, R ; Peyton, P ; Story, DA ; Leslie, K ; Forbes, A ; RELIEF trial investigators, (Wiley, 2023-11)
    Postoperative systemic inflammation is strongly associated with surgical outcomes, but its relationship with patient-centred outcomes is largely unknown. Detection of excessive inflammation and patient and surgical factors associated with adverse patient-centred outcomes should inform preventative treatment options to be evaluated in clinical trials and current clinical care. This retrospective cohort study analysed prospectively collected data from 3000 high-risk, elective, major abdominal surgery patients in the restrictive vs. liberal fluid therapy for major abdominal surgery (RELIEF) trial from 47 centres in seven countries from May 2013 to September 2016. The co-primary endpoints were persistent disability or death up to 90 days after surgery, and quality of recovery using a 15-item quality of recovery score at days 3 and 30. Secondary endpoints included: 90-day and 1-year all-cause mortality; septic complications; acute kidney injury; unplanned admission to intensive care/high dependency unit; and total intensive care unit and hospital stays. Patients were assigned into quartiles of maximum postoperative C-reactive protein concentration up to day 3, after multiple imputations of missing values. The lowest (reference) group, quartile 1, C-reactive protein ≤ 85 mg.l-1 , was compared with three inflammation groups: quartile 2 > 85 mg.l-1 to 140 mg.l-1 ; quartile 3 > 140 mg.l-1 to 200 mg.l-1 ; and quartile 4 > 200 mg.l-1 to 587 mg.l-1 . Greater postoperative systemic inflammation had a higher adjusted risk ratio (95%CI) of persistent disability or death up to 90 days after surgery, quartile 4 vs. quartile 1 being 1.76 (1.31-2.36), p < 0.001. Increased inflammation was associated with increasing decline in risk-adjusted estimated medians (95%CI) for quality of recovery, the quartile 4 to quartile 1 difference being -14.4 (-17.38 to -10.71), p < 0.001 on day 3, and -5.94 (-8.92 to -2.95), p < 0.001 on day 30. Marked postoperative systemic inflammation was associated with increased risk of complications, poor quality of recovery and persistent disability or death up to 90 days after surgery.
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    Postoperative anaemia and patient-centred outcomes after major abdominal surgery: a retrospective cohort study.
    Myles, PS ; Richards, T ; Klein, A ; Wood, EM ; Wallace, S ; Shulman, MA ; Martin, C ; Bellomo, R ; Corcoran, TB ; Peyton, PJ ; Story, DA ; Leslie, K ; Forbes, A ; RELIEF Trial Investigators, (Elsevier BV, 2022-09)
    BACKGROUND: Compared with anaemia before surgery, the underlying pathogenesis and implications of postoperative anaemia are largely unknown. METHODS: This retrospective cohort study analysed prospective data obtained from 2983 adult patients across 47 centres enrolled in a clinical trial evaluating restrictive and liberal intravenous fluids. The primary endpoint was persistent disability or death up to 90 days after surgery. Secondary endpoints included major septic complications, hospital stay, and patient quality of recovery using a 15-item quality of recovery (QoR-15) score, hospital re-admissions, and disability-free survival up to 12 months after surgery. Anaemia and disability were defined according to the WHO definitions. Multivariable regression was used to adjust for baseline risk and surgery. RESULTS: A total of 2983 patients met inclusion criteria for this study, of which 78.5% (95% confidence interval [CI], 76.7-80.1%) had postoperative anaemia. Patients with postoperative anaemia had a higher adjusted risk of death or disability up to 90 days after surgery when compared with those without anaemia: 18.2% vs 9.2% (risk ratio [RR]=1.51; 95% CI, 1.10-2.07, P=0.011); lower QoR-15 scores on Day 3 and Day 30, 105 (95% CI, 87-119) vs 114 (95% CI, 99-128; P<0.001), and 130 (95% CI, 112-140) vs 139 (95% CI, 121-144; P<0.011), respectively; higher adjusted risk of a composite of mortality/septic complications, 2.01 (95% CI, 1.55-42.67; P<0.001); unplanned admission to ICU (RR=2.65; 95% CI, 1.65-4.23; P<0.001); and longer median (inter-quartile range [IQR]) hospital stays, 6.6 (4.4-12.4) vs 3.7 (2.5-6.5) days (P<0.001). CONCLUSIONS: Postoperative anaemia is common and is independently associated with poor outcomes after surgery. Optimal prevention and treatment strategies need to be investigated. CLINICAL TRIAL REGISTRATION: NCT04978285 (ClinicalTrials.gov).
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    Exploring patient acceptability of a short-stay care pathway in hospital post arthroplasty: A theory-informed qualitative study
    McDonald, CE ; Paynter, C ; Francis, JJ ; Rodda, D ; Bajwa, S ; Jackson, D ; Story, D (WILEY, 2022-08)
    INTRODUCTION: Arthroplasty is an effective, yet costly, surgical procedure for end-stage osteoarthritis. Shorter stays in hospital are being piloted in Australia. In some countries, short stay is established practice, associated with improving perioperative care and enhanced recovery after surgery practices. Exploring the acceptability to patients of a short stay care pathway in hospital postarthroplasty is important for informing health policy, adoption and potential scalability of this model of care. METHODS: Consecutive patients at one site, at least 3 months post total joint arthroplasty, were invited to participate in theory-informed semi-structured qualitative interviews. The Theoretical Framework of Acceptability (TFA) informed development of the interview guide. Interview data were analysed using the Framework Method. RESULTS: Eighteen patients were invited. Fifteen consented to be contacted and were interviewed. Short-stay post arthroplasty was highly acceptable to patients who had the supports necessary to recover safely at home. Key findings were as follows: flexibility of short-stay care pathway was essential and valued; prior beliefs and expectations informed acceptability; and the absence of out-of-pocket expenses had an incentivizing effect, but was not the primary reason for patients choosing this care pathway. Further themes analysed within the TFA constructs highlighted nuances of acceptability relating to this model of care. CONCLUSIONS: A short stay in hospital post arthroplasty appeared to be acceptable to patients who had experienced this care pathway. Our thematic findings identified aspects of the short-stay care pathway that enhanced acceptability and some aspects that limited acceptability. These findings can inform refinement of the short-stay care pathway. PATIENT OR PUBLIC CONTRIBUTION: Patients/people with lived experience were not involved in the study design or conduct of this preliminary work; as this short-stay model of care was recently introduced, only a small group of patients was eligible to participate in this study. This study is the first step towards understanding the experiences of patients about a short-stay model of care post arthroplasty. The findings will help inform future patient and public involvement in expanding the programme.
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    The carbon footprint of hospital diagnostic imaging in Australia
    McAlister, S ; McGain, F ; Petersen, M ; Story, D ; Charlesworth, K ; Ison, G ; Barratt, A (ELSEVIER, 2022-07)
    BACKGROUND: Pathology testing and diagnostic imaging together contribute 9% of healthcare's carbon footprint. Whilst the carbon footprint of pathology testing has been undertaken, to date, the carbon footprint of the four most common imaging modalities is unclear. METHODS: We performed a prospective life cycle assessment at two Australian university-affiliated health services of five imaging modalities: chest X-ray (CXR), mobile chest X-ray (MCXR), computerised tomography (CT), magnetic resonance imaging (MRI) and ultrasound (US). We included scanner electricity use and all consumables and associated waste, including bedding, imaging contrast, and gloves. Analysis was performed using both attributional and consequential life cycle assessment methods. The primary outcome was the greenhouse gas footprint, measured in carbon dioxide equivalent (CO2e) emissions. FINDINGS: Mean CO2e emissions were 17·5 kg/scan for MRI; 9·2 kg/scan for CT; 0·8 kg/scan for CXR; 0·5 kg/scan for MCXR; and 0·5 kg/scan for US. Emissions from scanners from standby energy were substantial. When expressed as emissions per additional scan (results of consequential analysis) impacts were lower: 1·1 kg/scan for MRI; 1·1 kg/scan for CT; 0·6 kg/scan for CXR; 0·1 kg/scan for MCXR; and 0·1 kg/scan for US, due to emissions from standby power being excluded. INTERPRETATION: Clinicians and administrators can reduce carbon emissions from diagnostic imaging, firstly by reducing the ordering of unnecessary imaging, or by ordering low-impact imaging (X-ray and US) in place of high-impact MRI and CT when clinically appropriate to do so. Secondly, whenever possible, scanners should be turned off to reduce emissions from standby power. Thirdly, ensuring high utilisation rates for scanners both reduces the time they spend in standby, and apportions the impacts of the reduced standby power of a greater number of scans. This therefore reduces the impact on any individual scan, maximising resource efficiency. FUNDING: Healthy Urban Environments (HUE) Collaboratory of the Maridulu Budyari Gumal Sydney Partnership for Health, Education, Research and Enterprise MBG SPHERE. The National Health and Medical Research Council (NHMRC) PhD scholarship.
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    An evaluation of the outcome metric 'days alive and at home' in older patients after hip fracture surgery
    Wu, A ; Fahey, MT ; Cui, D ; El-Behesy, B ; Story, DA (WILEY, 2022-08)
    'Days alive and at home' is a validated measure that estimates the time spent at home, defined as the place of residence before admission to hospital. We evaluated this metric in older adults after hip fracture surgery and assessed two follow-up durations, 30 and 90 days. Patients aged ≥ 70 years who underwent hip fracture surgery were identified retrospectively via hospital admission and government mortality records. Patients who successfully returned home and were still alive within 90 days of surgery were distinguished from those who were not. Regression models were used to examine which variables were associated with failure to return home and number of days at home among those who did return, within 90 days of surgery. We analysed the records of 825 patients. Median (IQR [range]) number of days at home within 90 days (n = 788) was 54 (0-76 [0-88]) days and within 30 days (n = 797) it was 2 (0-21 [0-28]) days. Out of these, 274 (35%) patients did not return home within 90 days and 374 (47%) within 30 days after surgery. Known peri-operative risk-factors such as older age, pre-operative anaemia and postoperative acute renal impairment were associated with failure to return home. This study supports days alive and at home as a useful patient-centred outcome measure in older adults after hip fracture surgery. We recommend that this metric should be used in clinical trials and measured at 90, rather than 30, postoperative days. As nearly half of this patient population did not return home within 30 days, the shorter time-period catches fewer meaningful events.
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    Impact of a policy to improve the management of oral medications when patients are fasting before a procedure: an interrupted time series analysis
    To, T-P ; Braat, S ; Lim, A ; Brien, J-A ; Heland, M ; Hardidge, A ; Story, D (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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    Intraoperative low tidal volume ventilation and the risk of ICD-10 coded delirium and the use for antipsychotic medications
    Karalapillai, D ; Weinberg, L ; Serpa Neto, A ; Peyton, PJ ; Ellard, L ; Hu, R ; Pearce, B ; Tan, C ; Story, D ; O'Donnell, M ; Hamilton, P ; Oughton, C ; Galtieri, J ; Appu, S ; Wilson, A ; Eastwood, G ; Bellomo, R ; Jones, DA (BMC, 2022-05-16)
    BACKGROUND: Low tidal volume (VT) ventilation and its associated increase in arterial carbon dioxide (PaCO2) may affect postoperative neurologic function. We aimed to test the hypothesis that intraoperative low VT ventilation affect the incidence of postoperative ICD-10 coded delirium and/or the need for antipsychotic medications. METHODS: This is a post-hoc analysis of a large randomized controlled trial evaluating low vs. conventional VT ventilation during major non-cardiothoracic, non-intracranial surgery. The primary outcome was the incidence of ICD-10 delirium and/or the use of antipsychotic medications during hospital stay, and the absolute difference with its 95% confidence interval (CI) was calculated. RESULTS: We studied 1206 patients (median age of 64 [55-72] years, 59.0% males, median ARISCAT of 26 [19-37], and 47.6% of ASA 3). ICD-10 coded delirium and /or antipsychotic medication use was diagnosed in 11.2% with similar incidence between low and conventional VT ventilation (11.1% vs. 11.3%; absolute difference, -0.24 [95%CI, -3.82 to 3.32]; p = 0.894). There was no interaction between allocation group and type of surgery. CONCLUSION: In adult patients undergoing major surgery, low VT ventilation was not associated with increased risk of ICD-10 delirium and/or the use of antipsychotic medications during hospital stay. TRIAL REGISTRATION: ANZCTR Identifier: ACTRN12614000790640 .
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    Understanding implementability in clinical trials: a pragmatic review and concept map.
    Cumpston, MS ; Webb, SA ; Middleton, P ; Sharplin, G ; Green, S ; Australian Clinical Trials Alliance Reference Group on Impact and Implementation of CTN Trials, (Springer Science and Business Media LLC, 2021-03-26)
    BACKGROUND: The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability. METHODS: Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019. RESULTS: Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map. CONCLUSIONS: The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia. TRIAL REGISTRATION: This review did not include health-related outcomes and was therefore not eligible for registration in the PROSPERO register.
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    Intra-operative ventilator mechanical power as a predictor of postoperative pulmonary complications in surgical patients A secondary analysis of a randomised clinical trial
    Karalapillai, D ; Weinberg, L ; Neto A, S ; Peyton, P ; Ellard, L ; Hu, R ; Pearce, B ; Tan, CO ; Story, D ; O'Donnell, M ; Hamilton, P ; Oughton, C ; Galtieri, J ; Wilson, A ; Eastwood, G ; Bellomo, R ; Jones, DA (LIPPINCOTT WILLIAMS & WILKINS, 2022-01)
    BACKGROUND: Studies in critically ill patients suggest a relationship between mechanical power (an index of the energy delivered by the ventilator, which includes driving pressure, respiratory rate, tidal volume and inspiratory pressure) and complications. OBJECTIVE: We aimed to assess the association between intra-operative mechanical power and postoperative pulmonary complications (PPCs). DESIGN: Post hoc analysis of a large randomised clinical trial. SETTING: University-affiliated academic tertiary hospital in Melbourne, Australia, from February 2015 to February 2019. PATIENTS: Adult patients undergoing major noncardiothoracic, nonintracranial surgery. INTERVENTION: Dynamic mechanical power was calculated using the power equation adjusted by the respiratory system compliance (CRS). Multivariable models were used to assess the independent association between mechanical power and outcomes. MAIN OUTCOME MEASURES: The primary outcome was the incidence of PPCs within the first seven postoperative days. The secondary outcome was the incidence of acute respiratory failure. RESULTS: We studied 1156 patients (median age [IQR]: 64 [55 to 72] years, 59.5% men). Median mechanical power adjusted by CRS was 0.32 [0.22 to 0.51] (J min-1)/(ml cmH2O-1). A higher mechanical power was also independently associated with increased risk of PPCs [odds ratio (OR 1.34, 95% CI, 1.17 to 1.52); P < 0.001) and acute respiratory failure (OR 1.40, 95% CI, 1.21 to 1.61; P < 0.001). CONCLUSION: In patients receiving ventilation during major noncardiothoracic, nonintracranial surgery, exposure to a higher mechanical power was independently associated with an increased risk of PPCs and acute respiratory failure. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry no: 12614000790640.