Research without informed patient consent in incompetent patients.

Most patients needing intensive care cannot give informed consent to participation in research. This includes the most acutely and severely ill, with the highest mortality and morbidity where research has the greatest potential to improve patient outcomes. In these circumstances consent is usually sought from a substitute decision maker, but while survivors of intensive care believe substitute decision makers will look after their interests, evidence suggests substitute decision makers are poorly equipped for this task. Various models have been suggested for research without patient informed consent when intervention is urgent and cannot wait until first person consent is possible, including a waiver of consent if conditions are met. A nationally consistent model is proposed for Australia with a robust process for initial waiver of consent followed by first person consent to further research-related procedures or ongoing follow-up when this can be competently provided.

Changes in case-mix and outcomes of critically ill patients in an Australian tertiary intensive care unit.

Critical care service is expensive and the demand for such service is increasing in many developed countries. This study aimed to assess the changes in characteristics of critically ill patients and their effect on long-term outcome. This cohort study utilised linked data between the intensive care unit database and state-wide morbidity and mortality databases. Logistic and Cox regression was used to examine hospital survival and five-year survival of 22,298 intensive care unit patients, respectively. There was a significant increase in age, severity of illness and Charlson Comorbidity Index of the patients over a 16-year study period. Although hospital mortality and median length of intensive care unit and hospital stay remained unchanged, one- and five-year survival had significantly improved with time, after adjusting for age, gender; severity of illness, organ failure, comorbidity, 'new' cancer and diagnostic group. Stratified analyses showed that the improvement in five-year survival was particularly strong among patients admitted after cardiac surgery (P = 0.001). In conclusion, although critical care service is increasingly being provided to patients with a higher severity of acute and chronic illnesses, long-term survival outcome has improved with time suggesting that critical care service may still be cost-effectiveness despite the changes in case-mix.

Healthcare utilisation among patients discharged from hospital after intensive care.

Surviving critical illness can be life-changing and presents new healthcare challenges for patients after hospital discharge. This feasibility study aimed to examine healthcare service utilisation for patients discharged from hospital after intensive care unit stay. Following Ethics Committee approval, patients aged 18 years and older were recruited over three months. Those admitted after cardiac surgery, discharged to another facility or against medical advice were excluded. Patients were informed of the study by post and followed-up by telephone at two and six months after discharge. General practitioners were also contacted (44% responded). Among 187 patients discharged from hospital, 11 died, 25 declined to participate and 39 could not be contacted. For 112 patients (60%) who completed a survey, the majority (82%) went home from hospital and were cared for by their partner (53%). More than half of the patients (58%) reported taking the same number of medications after intensive care unit stay but 30% took more (P = 0.023). While there was no change in the number of visits to the general practitioner for 64% of patients, 29% reported an increase after intensive care unit stay. At six months, 40% of responders who were not retired were unemployed. Discharge summary surveys revealed 39 general practitioners (71%) were satisfied with details of ongoing healthcare needs. Twenty-one general practitioners wrote comments: 10 reported insufficient information about ongoing needs/rehabilitation and two reported no mention of intensive care unit stay. Survivors of critical illness had increased healthcare needs and despite most returning home, had a low workforce participation rate. This requires further investigation to maximise the benefits of survival from critical illness.

Effect of length of stay in intensive care unit on hospital and long-term mortality of critically ill adult patients.

BACKGROUND: Critical illness leading to prolonged length of stay (LOS) in an intensive care unit (ICU) is associated with significant mortality and resource utilization. This study assessed the independent effect of ICU LOS on in-hospital and long-term mortality after hospital discharge. METHODS: Clinical and mortality data of 22 298 patients, aged 16 yr and older, admitted to ICU between 1987 and 2002 were included in this linked-data cohort study. Cox's regression with restricted cubic spline function was used to model the effect of LOS on in-hospital and long-term mortality after adjusting for age, gender, acute physiology score (APS), maximum number of organ failures, era of admission, elective admission, Charlson's co-morbidity index, and diagnosis. The variability each predictor explained was calculated by the percentage of the chi(2) statistic contribution to the total chi(2) statistic. RESULTS: Most hospital deaths occurred within the first few days of ICU admission. Increasing LOS in ICU was not associated with an increased risk of in-hospital mortality after adjusting for other covariates, but was associated with an increased risk of long-term mortality after hospital discharge. The variability on the long-term mortality effect associated with ICU LOS (2.3%) appeared to reach a plateau after the first 10 days in ICU and was not as important as age (35.8%), co-morbidities (18.6%), diagnosis (10.9%), and APS (3.6%). CONCLUSIONS: LOS in ICU was not an independent risk factor for in-hospital mortality, but it had a small effect on long-term mortality after hospital discharge after adjustment for other risk factors.

Effect of an episode of critical illness on subsequent hospitalisation: a linked data study.

Healthcare utilisation can affect quality of life and is important in assessing the cost-effectiveness of medical interventions. A clinical database was linked to two Australian state administrative databases to assess the difference in incidence of healthcare utilisation of 19,921 patients who survived their first episode of critical illness. The number of hospital admissions and days of hospitalisation per patient-year was respectively 150% and 220% greater after than before an episode of critical illness (assessed over the same time period). This was the case regardless of age or type of surgery (i.e. cardiac vs non-cardiac). After adjusting for the ageing effect of the cohort as a whole, there was still an unexplained two to four-fold increase in hospital admissions per patient-year after an episode of critical illness. We conclude that an episode of critical illness is a robust predictor of subsequent healthcare utilisation.

Examining the occurrence of adverse events within 72 hours of discharge from the intensive care unit.

Adverse events have negative consequences for patients, including increased risk of death or permanent disability. Reports describe suboptimal patient care on hospital wards and reasons for re-admission to the intensive care unit (ICU) but limited data exists on the occurrence of adverse events, their characteristics and outcomes in patients recently discharged from the ICU to the ward. This prospective observational study describes the incidence and outcomes of adverse events within 72 hours of discharge from an Australian ICU over 12 weeks in 2006. Patients were excluded if they were admitted to ICU after booked surgery or uncomplicated drug overdose, were discharged from ICU to the high dependency unit or had a 'do-not-resuscitate' order Clinical antecedents and preventability were determined for each event. Seventeen (10%) of the 167 discharges that met the inclusion criteria were associated with an adverse event, with nine (52%) judged as probably preventable. Seven adverse events occurred from discharges between 1700 and 0700 hours and seven were on weekends. The most common adverse events were related to fluid management (47%). Outcomes included three ICU readmissions, two high dependency unit admissions and two required one-to-one ward nursing. Two adverse events resulted in temporary disability, seven resulted in prolonged hospital stays and two were associated with death. Delay in taking action for abnormal physiological signs and infrequent charting were evident. Whilst the adverse event rate compared favourably with other reports, 64% of the events were considered preventable. A review of support systems and processes is recommended to better target transition from the ICU.

The pressure effects of facemasks during noninvasive ventilation: a volunteer study.

Noninvasive ventilation by facemask is commonly used for patients with respiratory failure. We evaluated the pressure exerted by two types of facemask on the faces of 12 healthy volunteers while they were being given different levels of continuous or bi-level positive airway pressure ventilation. The mean (SD) pressure recorded on the bridge of the nose was much higher than that on the cheek (nose: 65.8 (21.2) vs cheek 15.4 (7.2) mmHg, p < 0.0001). Progressive tightening of the harness and increasing of the volume of air in the facemask cushions increased the pressure on the bridge of the nose, and the effect of these two factors was additive. Some commercially available facemasks can produce substantial pressure on the bridge of the nose and this explains why pressure complications on the bridge of the nose are common during noninvasive ventilation.

Data linkage enables evaluation of long-term survival after intensive care.

Outcomes of intensive care are important to the patient and for assessment of benefit. Short-term outcomes after critical illness are well described, but less is known about long-term outcomes. This study describes the use of data linkage, combining intensive care unit (ICU) clinical data with administrative morbidity and mortality data, to assess long-term outcomes after treatment in ICU. The hospital-based cohort study was conducted in a 22-bed general ICU in a metropolitan teaching hospital. All patient admissions admitted to ICU from 1 January 1987 to 31 December 2002 were included. The prospective ICU clinical database with patient demographics, ICU diagnoses, severity of illness, daily assessment of organ failures and common daily treatments used was linked using probabilistic methods to the state-wide hospital morbidity and mortality databases to describe long-term survival. There were 26,019 ICU admissions (22,980 patients) with 25,972 records (99.8%) linked to a hospitalization event that included the index ICU admission. Unadjusted survival was 84.7% at 1 year decreasing progressively to 50.7% at 15 years. Age, type of admission, severity of illness (measured by Acute Physiologic and Chronic Health Evaluation (APACHE) II and the presence of organ failure), ICU length of stay, comorbidity (Chronic Health Evaluation and Charlson comorbidity index) and ICU admission diagnosis, were all associated with survival at 1, 3, 5, 10, and 15 year follow-up (P<0.001 at all time points). Linkage of clinical and administrative data provides a feasible method for ascertaining long-term survival after critical illness. Age, admission severity of illness, diagnosis and comorbidity influenced long-term unadjusted survival.

The effect of different bypass flow rates and low-dose dopamine on gut mucosal perfusion and outcome in cardiac surgical patients.

The aim of this double-blind, randomized, placebo-controlled trial was to investigate the effects of different cardiopulmonary bypass flow rates and low-dose dopamine on gastric mucosal pH (pHi) and outcome. We hypothesized that by minimizing gut mucosal hypoperfusion during and after cardiac surgery endotoxin translocation may be prevented, resulting in an improved clinical outcome. Four groups of 25 patients each receiving high or low flows during bypass and low-dose dopamine or saline for 24 hours after induction of anaesthesia were studied. The pHi was measured at six time intervals over 24 hours. The combination of low-dose dopamine and a low bypass flow rate was associated with a significantly greater frequency and severity of low pHi. This group also demonstrated a significantly lower vascular resistance on admission to the intensive care unit. There may be an association between low pHi and low vascular resistance.

Critical care medicine in the Western Pacific region.

The Western Pacific region has seen rapid recent economic development but variation in the provision and organisation of intensive care units (ICUs) between different countries remains. While Japan, Australia, New Zealand, Singapore, Taiwan, Korea and Hong Kong have well developed intensive care facilities, in other countries the more limited funding for healthcare can be reflected by differential availability of modern medical technology between the public and private sectors. Other factors important to intensive care include physician training, availability of other staff and whether intensive care is delivered in "open" or "closed" units. At present only Japan, Hong Kong, the Philippines, Australia and New Zealand have a postgraduate examination in intensive care leading to recognition as an intensive care physician. In Japan, Australia, New Zealand and Indonesia each hospital usually has a single multidisciplinary (medical-surgical) ICU, whereas most other Western Pacific countries have divided medical and surgical units. In Japan, Australia, New Zealand, Hong Kong, Taiwan and Thailand, the larger ICUs are usually staffed by full-time intensivists. Future development of intensive care in the region will parallel economic development. In most countries increasing patient expectations, ageing populations and "Western" diseases will increase demand for intensive care services. Only a few countries currently have recognised programmes of training and certification in intensive care but as more adopt this process it should lead to a clearer recognition and acceptance of the role of the intensivist.

The use of antimicrobials in ten Australian and New Zealand intensive care units. The Australian and New Zealand Intensive Care Multicentre Studies Group Investigators.

A prospective standardized collection of clinical, microbiological and pharmaceutical information on antibiotic use was conducted in Australia and New Zealand intensive care units (ICUs) involving 481 consecutive critically ill patients who were receiving antibiotics for any reason while in ICU. Patients had a mean SAPS II score of 34.1 +/- 17.8 with an expected mortality of 15.6% (actual mortality 12%). Of these, 292 (60.8%) were admitted to the ICU within 72 hours of surgery. Among such surgical patients, 233 (79.9%) received antibiotics for "surgical prophylaxis" while in ICU (48% of sample population). The second largest group of patients treated with antibiotics in ICU included those with systemic inflammatory response syndrome and clinical suspicion of infection (38%). Antibiotics were prescribed for the treatment of clinically diagnosed infection in 268 patients. Clinical response was apparent in 62.6% and in most (71%) was achieved in the first 72 hours of treatment. The incidence of antimicrobial-related side-effects was 4%, mostly in the form of diarrhoea or rash (75% of all side-effects). The most commonly prescribed antimicrobials were gentamicin (n = 146), ceftriaxone (n = 98), vancomycin (n = 94) and metronidazole (n = 111). Three times daily prescription of aminoglycosides was uncommon (< 1%). Forty-one patients had a documented infection (positive culture) with a gram-negative organism. Of these, 17 received therapy with a single antibiotic and 24 received therapy with two antibiotics. Despite similar illness severity, there were six deaths in the former group and only two in the latter.

Intensive care in Australia and New Zealand. No nonsense "down under".

The year 1996 was the 21st birthday of the Australian and New Zealand Annual Scientific Meeting on Intensive Care. With this maturity many of the issues that were so troublesome to intensive care in the early years relating to identity, training, recognition, and standards have largely resolved. There are, however, no signs of complacency. We need to improve the image of a career in intensive care to trainees, expand research opportunities, and respond to the ever-changing challenges coming from administrative reorganization, budgeting constraints, and increasing public expectations. I believe the foundations have been well laid to ensure a continuing contribution by Australian and New Zealand intensivists to clinical intensive care, their hospitals, ANZICS, and a place in the global research effort in intensive care.

Magnesium in cardiac arrest (the magic trial).

The prognosis of out of hospital cardiac arrest (OHCA) is dismal. Recent reports indicate that high dose magnesium may improve survival. A prospective randomized double blind placebo controlled trial was conducted at the emergency department (ED) of Royal Perth Hospital, a University teaching hospital. Patients with OHCA of cardiac origin received either 5 g MgSO4 or placebo as first line drug therapy. The remainder of their management was standard advanced cardiac life support (ACLS). Study endpoints were: (1) ECG rhythm 2 min after the trial drug; (2) return of spontaneous circulation; (3) survival to leave the ED; (4) survival to leave intensive care; and (5) survival to hospital discharge. Of 67 patients enrolled, 31 received magnesium and 36 placebo. There were no significant differences between groups for all criteria, except that there were significantly more arrests witnessed after arrival of EMS personnel in the magnesium group (11 or 35% vs 4 or 11%). Return of spontaneous circulation occurred in seven (23%) patients receiving magnesium and eight (22%) placebo. Four patients in each group survived to leave the ED and one from the magnesium group survived to hospital discharge. There were no survivors in the placebo group. In this study, the use of high dose magnesium as first line drug therapy for OHCA was not associated with a significantly improved survival. Early defibrillation remains the single most important treatment for ventricular fibrillation (VF). Further studies are required to evaluate the role of magnesium in cardiac and cerebral resuscitation.

Intravenous flecainide versus amiodarone for recent-onset atrial fibrillation.

In a randomized, double-blind, controlled study of 98 patients with atrial fibrillation (AF) (present for > or = 30 minutes, < or = 72 hours, and a ventricular response of > or = 100 beats/min), intravenous flecainide (2 mg/kg, maximum 150 mg) was compared with intravenous amiodarone (7 mg/kg) and placebo. Exclusion criteria included significant left ventricular dysfunction, inotrope dependence, recent antiarrhythmic therapy, hypokalemia, and pacemaker dependence. Reversion to stable sinus rhythm within 2 hours of starting medication was considered likely to be due to drug effect. Twenty of 34 patients (59%) given flecainide, 11 of 32 (34%) given amiodarone, and 7 of 32 (22%) given placebo reverted to stable sinus rhythm in < or = 2 hours after starting medication (chi-square 9.87, p = 0.007). More patients reverted to stable rhythm with flecainide than with placebo (p = 0.005; odds ratio 5.1, 95% confidence interval 1.54 to 17.5). There was no significant difference between amiodarone and placebo or between flecainide and amiodarone. However, after 8 hours there were no significant differences in reversion between the treatment groups: flecainide (n = 23, 68%), amiodarone (n = 19, 59%), and placebo (n = 18, 56%). Amiodarone promptly reduced the ventricular rate, and this effect was maintained for 8 hours in those whose reversion to stable sinus rhythm was unsuccessful: flecainide was no more effective than placebo in controlling ventricular rate. Adverse effects were not significantly different in the 3 groups. Thus, intravenous flecainide results in earlier reversion of AF than does intravenous amiodarone or placebo. Amiodarone, although less effective in reverting AF, slows the rapid ventricular response.(ABSTRACT TRUNCATED AT 250 WORDS)

Efficacy of flecainide for the reversion of acute onset atrial fibrillation.

The efficacy and safety of intravenous flecainide to convert recent-onset atrial fibrillation (AF) (present for greater than or equal to 30 minutes and less than or equal to 72 hours and a ventricular response greater than or equal to 120 beats/min) was investigated. A total of 102 patients without severe heart or circulatory failure were randomized to receive either intravenous flecainide (2 mg/kg, maximum dose 150 mg; 51 patients) or placebo (51 patients) in a double-blind trial. Digoxin (500 micrograms intravenously) was administered to all patients who had not previously been receiving digoxin. The electrocardiogram was monitored continuously during the study. In 29 (57%) patients stable sinus rhythm was restored within 1 hour after flecainide and in only 7 (14%) given placebo (chi square 18.9; p = 0.000013; odds ratio 8.3; 95% confidence interval 2.9-24.8). Reversion to sinus rhythm within 1 hour after starting the trial medication was considered a pretrial end point and likely to be due to a drug effect. At the end of the 6-hour monitoring period, 34 patients (67%) in the flecainide group were in sinus rhythm whereas only 18 (35%) in the placebo group had reverted (chi square 8.83, p = 0.003; odds ratio 3.67; 95% confidence interval 1.5-9.1). Significant hypotension, although short lived, was more common in the flecainide group. One patient given flecainide developed torsades de pointes and was successfully electrically cardioverted. Flecainide is useful for the management of recent-onset AF both for control of the ventricular response and conversion to sinus rhythm.(ABSTRACT TRUNCATED AT 250 WORDS)

Hemodynamic benefit of maintaining atrioventricular synchrony during cardiac pacing in critically ill patients.

OBJECTIVE: To determine the hemodynamic effects of maintaining atrioventricular synchrony during emergency cardiac pacing in critically ill patients. DESIGN: Prospective, within patient double-blind study. SETTING: ICU or coronary care unit patients in a university hospital. PATIENTS: Forty (23 cardiac surgery, ten acute myocardial infarction, and seven general intensive care) seriously ill patients with severe symptomatic bradycardia. INTERVENTION: Initial randomization of patients to receive either a pacing mode where atrioventricular synchronization was maintained (atrioventricular pacing: atrial demand, atrioventricular sequential, atrioventricular universal) or a mode of pacing where atrioventricular synchrony was not preserved (ventricular demand pacing). MEASUREMENTS AND MAIN RESULTS: The cardiac output increased from a mean of 4.5 +/- 1.7 L/min (95% confidence intervals: 4.0 to 5.0 L/min) during ventricular demand pacing to 5.3 +/- 1.7 L/min (95% confidence intervals: 4.9 to 5.9 L/min) during atrioventricular pacing (p less than .0001) despite trivial decreases in CVP from 14 +/- 4 mm Hg (95% confidence intervals: 13 to 15 mm Hg) to 13 +/- 5 mm Hg (95% confidence intervals: 12 to 15 mm Hg) and pulmonary artery occlusion pressure from 18 +/- 5 mm Hg (95% confidence intervals: 16 to 20 mm Hg) to 17 +/- 5 mm Hg (95% confidence intervals: 15 to 18 mm Hg). At the same time, mean arterial pressure (MAP) increased from 74 +/- 15 mm Hg (95% confidence intervals: 64 to 79 mm Hg) to 83 +/- 15 mm Hg (95% confidence intervals: 80 to 88 mm Hg) and left ventricular stroke work index from 22 +/- 10 g.m/m2 (95% confidence intervals: 19 to 25 g.m/m2) to 30 +/- 11 g.m/m2 (95% confidence intervals: 26 to 33 g.m/m2). There was no significant change in mean pulmonary artery pressure, pulmonary vascular resistance index, or systemic vascular resistance index. CONCLUSION: When cardiac pacing is required in critically ill patients, maintaining atrioventricular synchrony increases stroke volume, cardiac output, and MAP apparently with minimal effects on preload and afterload.