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ABSTRACT: Delirium, an acute brain dysfunction, frequently affects intensive care unit (ICU) patients during the course of a critical illness. Besides the acute morbidities, ICU survivors often experience long-term sequelae in the form of cognitive impairment (LTCI-CI). Though delirium and LTCI-CI are associated with adverse outcomes, little is known on the terminology used to define these acute and chronic co-morbidities. The use of a correct terminology is a key factor to spread the knowledge on clinical conditions. Therefore, we first review the epidemiology, definition of delirium and its related terminology. Second, we report on the epidemiology of LTCI-CI and compare its definition to other forms of cognitive impairments. In particular, we define mild cognitive impairment, dementia and finally postoperative cognitive dysfunction. Future research is needed to interpret the trajectories of LTCI-CI, to differentiate it from neurodegenerative diseases and to provide a formal disease classification.
Best practice & research. Clinical anaesthesiology. 09/2012; 26(3):267-76.
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James C Jackson, E Wesley Ely,
Miriam C Morey,
Venice M Anderson,
Laural B Denne,
Jennifer Clune,
Carol S Siebert,
Kristin R Archer,
Renee Torres,
David Janz,
Elena Schiro,
Julie Jones,
Ayumi K Shintani,
Brian Levine,
Brenda T Pun,
Jennifer Thompson,
Nathan E Brummel,
Helen Hoenig
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ABSTRACT: Millions of patients who survive medical and surgical general intensive care unit care every year experience newly acquired long-term cognitive impairment and profound physical and functional disabilities. To overcome the current reality in which patients receive inadequate rehabilitation, we devised a multifaceted, in-home, telerehabilitation program implemented using social workers and psychology technicians with the goal of improving cognitive and functional outcomes.
This was a single-site, feasibility, pilot, randomized trial of 21 general medical/surgical intensive care unit survivors (8 controls and 13 intervention patients) with either cognitive or functional impairment at hospital discharge. After discharge, study controls received usual care (sporadic rehabilitation), whereas intervention patients received a combination of in-home cognitive, physical, and functional rehabilitation over a 3-month period via a social worker or master's level psychology technician utilizing telemedicine to allow specialized multidisciplinary treatment. Interventions over 12 wks included six in-person visits for cognitive rehabilitation and six televisits for physical/functional rehabilitation. Outcomes were measured at the completion of the rehabilitation program (i.e., at 3 months), with cognitive functioning as the primary outcome. Analyses were conducted using linear regression to examine differences in 3-month outcomes between treatment groups while adjusting for baseline scores.
Patients tolerated the program with only one adverse event reported. At baseline both groups were well-matched. At 3-month follow-up, intervention group patients demonstrated significantly improved cognitive executive functioning on the widely used and well-normed Tower test (for planning and strategic thinking) vs. controls (median [interquartile range], 13.0 [11.5-14.0] vs. 7.5 [4.0-8.5]; adjusted p < .01). Intervention group patients also reported better performance (i.e., lower score) on one of the most frequently used measures of functional status (Functional Activities Questionnaire at 3 months vs. controls, 1.0 [0.0 -3.0] vs. 8.0 [6.0-11.8], adjusted p = .04).
A multicomponent rehabilitation program for intensive care unit survivors combining cognitive, physical, and functional training appears feasible and possibly effective in improving cognitive performance and functional outcomes in just 3 months. Future investigations with a larger sample size should be conducted to build on this pilot feasibility program and to confirm these results, as well as to elucidate the elements of rehabilitation contributing most to improved outcomes.
Critical care medicine 11/2011; 40(4):1088-97. · 6.37 Impact Factor
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ABSTRACT: Delirium occurs frequently in the intensive care unit (ICU), but its pathophysiology is still unclear. Low levels of insulin-like growth factor 1 (IGF-1), a hormone with neuroprotective properties, have been associated with delirium in some non-ICU studies, but this relationship has not been examined in the ICU. We sought to test the hypothesis that low IGF-1 concentrations are associated with delirium during critical illness.
Mechanically ventilated medical ICU patients were prospectively enrolled, and blood was collected after enrollment for measurement of IGF-1 using radioimmunometric assay. Delirium and coma were identified daily using the Confusion Assessment Method for the ICU and the Richmond Agitation-Sedation Scale, respectively. The association between IGF-1 and delirium was evaluated with logistic regression. In addition, the association between IGF-1 and duration of normal mental state, measured as days alive without delirium or coma, was assessed using multiple linear regression.
Among 110 patients, the median age was 65 years (IQR, 52-75) and APACHE II was 27 (IQR, 22 -32). IGF-1 levels were not a risk factor for delirium on the day after IGF-1 measurement (p = 0.97), at which time 65% of the assessable patients were delirious. No significant association was found between IGF-1 levels and duration of normal mental state (p = 0.23).
This pilot study, the first to investigate IGF-1 and delirium in critically ill patients, found no association between IGF-1 and delirium. Future studies including serial measurements of IGF-1 and IGF-1 binding proteins are needed to determine whether this hormone has a role in delirium during critical illness.
International Psychogeriatrics 02/2011; 23(7):1175-81. · 2.24 Impact Factor
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T Speroff,
S Nwosu,
R Greevy,
M B Weinger,
T R Talbot,
R J Wall,
J K Deshpande,
D J France, E W Ely,
H Burgess,
J Englebright,
M V Williams,
R S Dittus
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ABSTRACT: Bureaucratic organisational culture is less favourable to quality improvement, whereas organisations with group (teamwork) culture are better aligned for quality improvement.
To determine if an organisational group culture shows better alignment with patient safety climate.
Cross-sectional administration of questionnaires. Setting 40 Hospital Corporation of America hospitals.
1406 nurses, ancillary staff, allied staff and physicians.
Competing Values Measure of Organisational Culture, Safety Attitudes Questionnaire (SAQ), Safety Climate Survey (SCSc) and Information and Analysis (IA).
The Cronbach alpha was 0.81 for the group culture scale and 0.72 for the hierarchical culture scale. Group culture was positively correlated with SAQ and its subscales (from correlation coefficient r = 0.44 to 0.55, except situational recognition), ScSc (r = 0.47) and IA (r = 0.33). Hierarchical culture was negatively correlated with the SAQ scales, SCSc and IA. Among the 40 hospitals, 37.5% had a hierarchical dominant culture, 37.5% a dominant group culture and 25% a balanced culture. Group culture hospitals had significantly higher safety climate scores than hierarchical culture hospitals. The magnitude of these relationships was not affected after adjusting for provider job type and hospital characteristics.
Hospitals vary in organisational culture, and the type of culture relates to the safety climate within the hospital. In combination with prior studies, these results suggest that a healthcare organisation's culture is a critical factor in the development of its patient safety climate and in the successful implementation of quality improvement initiatives.
Quality and Safety in Health Care 12/2010; 19(6):592-6. · 1.68 Impact Factor
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N A L Pratik,
Pandharipande A Bryan,
Ayumi Cotton,
Jennifer Shintani,
Sean Thompson,
Brenda Truman Costabile,
Robert Pun,
E Wesley Dittus,
Ely,
P Pandharipande,
· S Costabile,
B A Cotton,
A Shintani,
· R Dittus, · E W Ely,
J Thompson,
B Truman Pun
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ABSTRACT: Objective: Acute brain dysfunction or delirium occurs in the majority of mechanically ventilated (MV) medical intensive care unit (ICU) patients and is associated with increased mortality. Unfortunately delirium often goes undiagnosed as health care providers fail to recognize in particular the hypoactive form that is characterized by depressed consciousness without the positive symptoms such as agitation. Recently, clinical tools have been developed that help to diagnose delirium and determine the subtypes. Their use, however, has not been reported in surgical and trauma patients. The objective of this study was to iden-tify the prevalence of the motoric subtypes of delirium in surgical and trauma ICU patients. Methods: Adult surgical and trauma ICU patients re-quiring MV longer than 24 h were prospectively evaluated for arousal and delirium using well validated instruments. Sedation and delirium were assessed using the Richmond Agitation Sedation Scale (RASS) and the Confusion Assessment Method in the ICU (CAM-ICU), respectively. Patients were monitored for delirium for a maximum of 10 days or until ICU discharge. Patients: A total of 100 ICU patients (46 surgical and 54 trauma) were enrolled in this study. Three patients were excluded from the final analysis because they stayed persistently comatose prior to their death. Measurements and results: Prevalence of delirium was 70% for the entire study population with 73% surgical and 67% trauma ICU patients having delirium. Evaluation of the subtypes of delirium revealed that in surgical and trauma patients, hypoactive delirium (64% and 60%, respectively) was significantly more prevalent than the mixed (9% and 6%) and the pure hyperactive delir-ium (0% and 1%). Conclusions: The prevalence of the hypoactive or "quiet" subtype of delirium in surgi-cal and trauma ICU patients appears similar to that of previously pub-lished data in medical ICU patients. In the absence of active monitoring with a validated clinical instrument (CAM-ICU), however, this subtype of delirium goes undiagnosed and the prevalence of delirium in surgical and trauma ICU patients remains greatly underestimated.
Intensive Care Med. 01/2007; 33:1726-1731.
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ABSTRACT: Delirium is a serious and prevalent problem in intensive care units (ICU). The purpose of this study was to develop a research algorithm to enhance detection of delirium in critically ill ICU patients using chart review to complement a validated clinical delirium instrument.
Prospective cohort study of 178 patients 60 years and older admitted to the Medical ICU. The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and a validated chart review method for delirium were performed daily. We assessed the diagnostic accuracy of the chart-based delirium method using the CAM-ICU as the gold standard. We then used an algorithm to detect delirium first using the CAM-ICU ratings, then chart review when the CAM-ICU was unavailable.
When using both the CAM-ICU and the chart-based review the prevalence of delirium was 143/178 (80%) patients or 929/1457 (64%) of patient-days. Of these, 292 patient-days were classified as delirium by the CAM-ICU, and the remainder (n=637 patient-days) were classified as delirium by the validated chart review method when the CAM-ICU was missing due to weekends or holidays (404 patient-days), when CAM-ICU was not performed due to stupor or coma (205 patient-days), and when the CAM-ICU was negative (28 patient-days). Sensitivity of the chart-based method was 64% and specificity was 85%. Overall agreement between chart and the CAM-ICU was 72%.
Eight of 10 patients in this cohort study developed delirium in the ICU. Although use of a validated delirium instrument with frequent direct observations is recommended for clinical care, this approach may not always be feasible, especially in a research setting. The algorithm proposed here comprises a more comprehensive method for delirium detection in a research setting taking into account the fluctuation that occurs with delirium, a key component to accurately determining delirium status. Improving delirium detection is of paramount importance first to advance delirium research and, subsequently to enhance clinical care and patient safety.
Critical care (London, England) 02/2006; 10(4):R121. · 4.61 Impact Factor
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ABSTRACT: While most patients recover uneventfully from the effects of anesthesia and surgery, for a small percentage of patients the immediate postoperative period can be a period of significant physiological stress. Hence the goal for a Post Anesthesia Care Unit (PACU) is to provide a safe environment for a patient to recover, while avoiding the undesirable side effects of pain, nausea, vomiting and shivering, and to monitor for potentially life threatening hemodynamic and respiratory complications that may require admission into the intensive care unit (ICU). Anesthetic techniques in the operating room are extremely important as these may have significant bearing on the post-operative course. The type of surgery, the patients' co morbid conditions, anticipated extubation and recovery of the patient, as well as the sophistication of the PACU and the expertise of its staff, all influence the choice of anesthetic technique. These agents, however, may themselves contribute to some of the complications and unpleasant events encountered in the PACU. Therefore, evaluation of newer and safer agents, which promote a smoother PACU transition, are warranted. Alpha 2 agonists are increasingly being used as adjuvant therapeutic agents in the perioperative period because of their ability to block the sympathetic stress response, complete with their anesthetic and analgesic sparing properties, lack of respiratory depression and low and predictable side effect profile.
Current Drug Targets 12/2005; 6(7):749-54. · 3.55 Impact Factor
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ABSTRACT: Measuring a process of care in real time is essential for continuous quality improvement (CQI). Our inability to measure the process of central venous catheter (CVC) care in real time prevented CQI efforts aimed at reducing catheter related bloodstream infections (CR-BSIs) from these devices.
A system was developed for measuring the process of CVC care in real time. We used these new process measurements to continuously monitor the system, guide CQI activities, and deliver performance feedback to providers.
Adult medical intensive care unit (MICU).
Measured process of CVC care in real time; CR-BSI rate and time between CR-BSI events; and performance feedback to staff.
An interdisciplinary team developed a standardized, user friendly nursing checklist for CVC insertion. Infection control practitioners scanned the completed checklists into a computerized database, thereby generating real time measurements for the process of CVC insertion. Armed with these new process measurements, the team optimized the impact of a multifaceted intervention aimed at reducing CR-BSIs.
The new checklist immediately provided real time measurements for the process of CVC insertion. These process measures allowed the team to directly monitor adherence to evidence-based guidelines. Through continuous process measurement, the team successfully overcame barriers to change, reduced the CR-BSI rate, and improved patient safety. Two years after the introduction of the checklist the CR-BSI rate remained at a historic low.
Measuring the process of CVC care in real time is feasible in the ICU. When trying to improve care, real time process measurements are an excellent tool for overcoming barriers to change and enhancing the sustainability of efforts. To continually improve patient safety, healthcare organizations should continually measure their key clinical processes in real time.
Quality and Safety in Health Care 09/2005; 14(4):295-302. · 1.68 Impact Factor
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12/2004: pages 437-448;
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ABSTRACT: Advances in organization and patient management in the intensive care unit (ICU) have led to reductions in the morbidity and mortality suffered by critically ill patients. Two such advances include multidisciplinary teams (MDTs) and the development of clinical protocols. The use of protocols and MDTs does not necessarily guarantee instant improvement in the quality of care, but it does offer useful tools for the pursuit of such objectives. As ICU physicians increasingly assume leadership roles in the pursuit of higher quality ICU care, their knowledge and skills in the discipline of quality improvement will become essential.
Critical Care 01/2002; 5(6):283-5. · 4.93 Impact Factor
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ABSTRACT: Health-care professionals (HCPs) can provide protocol-based care that has a measurable impact on critically ill patients beyond their liberation from mechanical ventilation (MV). Randomized controlled trials have demonstrated that protocols for liberating patients from MV driven by nonphysician HCPs can reduce the duration of MV. The structure and features of protocols should be adapted from published protocols to incorporate patient-specific needs, clinician preferences, and institutional resources. As a general approach, shortly after patients demonstrate that their condition has been stabilized on the ventilator, a spontaneous breathing trial (SBT) is safe to perform and is indicated. Ventilator management strategies for patients who fail a trial of spontaneous breathing include the following: (1) consideration of all remediable factors (such as electrolyte derangements, bronchospasm, malnutrition, patient positioning, and excess secretions) to enhance the prospects of successful liberation from MV; (2) use of a comfortable, safe, and well-monitored mode of MV (such as pressure support ventilation); and (3) repeating a trial of spontaneous breathing on the following day. For patients who pass the SBT, the decision to extubate must be guided by clinical judgment and objective data to minimize the risk of unnecessary reintubations and self-extubations. Protocols should not represent rigid rules but, rather, guides to patient care. Moreover, the protocols may evolve over time as clinical and institutional experience with them increases. Useful protocols aim to safely and efficiently liberate patients from MV, reducing unnecessary or harmful variations in approach.
Chest 01/2002; 120(6 Suppl):454S-63S. · 5.25 Impact Factor
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ABSTRACT: To determine the relationship between delirium in the intensive care unit (ICU) and outcomes including length of stay in the hospital.
A prospective cohort study.
The adult medical ICU of a tertiary care, university-based medical center.
The study population consisted of 48 patients admitted to the ICU, 24 of whom received mechanical ventilation.
All patients were evaluated for the development and persistence of delirium on a daily basis by a geriatric or psychiatric specialist with expertise in delirium assessment using the Diagnostic Statistical Manual IV (DSM-IV) criteria of the American Psychiatric Association, the reference standard for delirium ratings. Primary outcomes measured were length of stay in the ICU and hospital.
The mean onset of delirium was 2.6 days (S.D.+/-1.7), and the mean duration was 3.4+/-1.9 days. Of the 48 patients, 39 (81.3%) developed delirium, and of these 29 (60.4%) developed the complication while still in the ICU. The duration of delirium was associated with length of stay in the ICU ( r=0.65, P=0.0001) and in the hospital ( r=0.68, P<0.0001). Using multivariate analysis, delirium was the strongest predictor of length of stay in the hospital ( P=0.006) even after adjusting for severity of illness, age, gender, race, and days of benzodiazepine and narcotic drug administration.
In this patient cohort, the majority of patients developed delirium in the ICU, and delirium was the strongest independent determinant of length of stay in the hospital. Further study and monitoring of delirium in the ICU and the risk factors for its development are warranted.
Intensive Care Medicine 12/2001; 27(12):1892-900. · 5.40 Impact Factor
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E W Ely,
S K Inouye,
G R Bernard,
S Gordon,
J Francis,
L May,
B Truman,
T Speroff,
S Gautam,
R Margolin,
R P Hart,
R Dittus
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ABSTRACT: Delirium is a common problem in the intensive care unit (ICU). Accurate diagnosis is limited by the difficulty of communicating with mechanically ventilated patients and by lack of a validated delirium instrument for use in the ICU.
To validate a delirium assessment instrument that uses standardized nonverbal assessments for mechanically ventilated patients and to determine the occurrence rate of delirium in such patients.
Prospective cohort study testing the Confusion Assessment Method for ICU Patients (CAM-ICU) in the adult medical and coronary ICUs of a US university-based medical center.
A total of 111 consecutive patients who were mechanically ventilated were enrolled from February 1, 2000, to July 15, 2000, of whom 96 (86.5%) were evaluable for the development of delirium and 15 (13.5%) were excluded because they remained comatose throughout the investigation.
Occurrence rate of delirium and sensitivity, specificity, and interrater reliability of delirium assessments using the CAM-ICU, made daily by 2 critical care study nurses, compared with assessments by delirium experts using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria.
A total of 471 daily paired evaluations were completed. Compared with the reference standard for diagnosing delirium, 2 study nurses using the CAM-ICU had sensitivities of 100% and 93%, specificities of 98% and 100%, and high interrater reliability (kappa = 0.96; 95% confidence interval, 0.92-0.99). Interrater reliability measures across subgroup comparisons showed kappa values of 0.92 for those aged 65 years or older, 0.99 for those with suspected dementia, or 0.94 for those with Acute Physiology and Chronic Health Evaluation II scores at or above the median value of 23 (all P<.001). Comparing sensitivity and specificity between patient subgroups according to age, suspected dementia, or severity of illness showed no significant differences. The mean (SD) CAM-ICU administration time was 2 (1) minutes. Reference standard diagnoses of delirium, stupor, and coma occurred in 25.2%, 21.3%, and 28.5% of all observations, respectively. Delirium occurred in 80 (83.3%) patients during their ICU stay for a mean (SD) of 2.4 (1.6) days. Delirium was even present in 39.5% of alert or easily aroused patient observations by the reference standard and persisted in 10.4% of patients at hospital discharge.
Delirium, a complication not currently monitored in the ICU setting, is extremely common in mechanically ventilated patients. The CAM-ICU appears to be rapid, valid, and reliable for diagnosing delirium in the ICU setting and may be a useful instrument for both clinical and research purposes.
JAMA The Journal of the American Medical Association 12/2001; 286(21):2703-10. · 30.03 Impact Factor
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G R Bernard, E W Ely,
T J Wright,
J Fraiz,
J E Stasek,
J A Russell,
I Mayers,
B A Rosenfeld,
P E Morris,
S B Yan,
J D Helterbrand
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ABSTRACT: To assess the safety and effect on coagulopathy of a range of doses of recombinant human activated protein C (rhAPC). To determine an effective dose and duration of rhAPC for use in future clinical trials.
Double-blind, randomized, placebo-controlled, multicenter, dose-ranging (sequential), phase II clinical trial.
Forty community or academic medical institutions in United States and Canada.
One hundred thirty-one adult patients with severe sepsis.
Intravenous infusion of rhAPC (12, 18, 24, or 30 microg/kg/hr) or placebo for 48 or 96 hrs.
No significant differences in incidence of serious bleeding events (4% rhAPC, 5% placebo, p >.999) or incidence of serious adverse events (39% rhAPC, 46% placebo, p = 0.422) between rhAPC- and placebo-treated patients were observed. One of 53 rhAPC-treated patients with suitable immunogenicity samples had a low level, transient, non-neutralizing anti-APC antibody response not associated with any clinical adverse event. Significant dose-dependent decreases in both D-dimer (p <0.001) and end of infusion interleukin 6 levels (p =.021) were demonstrated. No statistically significant effects on fibrinogen or platelet counts were observed. A nonstatistically significant 15% relative risk reduction in 28-day all-cause mortality was observed between rhAPC- and placebo-treated patients.
rhAPC was safe and well-tolerated and demonstrated a dose-dependent reduction in D-dimer and interleukin 6 levels relative to placebo. The dose of 24 microg/kg/hr for 96 hrs was selected for use in future clinical studies.
Critical Care Medicine 11/2001; 29(11):2051-9. · 6.33 Impact Factor
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Western Journal of Medicine 10/2001; 175(3):197-201.
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ABSTRACT: The care of critically ill patients and the advent of the modern day intensive care unit (ICU) present a large person power and cost burden to society. The high cost of critical care is attributed to high overhead expenses (eg, experienced staff and equipment), high resource utilization (eg, pharmaceutical resources, lab testing, imaging procedures), and high demand for services. Pathways to standardize numerous facets of patient care have been shown to improve the efficiency of delivery of care and to reduce resource utilization, and are becoming the most sought-after means of improving patient outcomes and reducing overall ICU expenditures. A number of large, randomized, prospective trials have demonstrated that protocol-based strategies can not only reduce variation and cost of ICU medicine but also improve morbidity and mortality of critically ill patients requiring ICU support. In this article, we discuss examples of these trials investigating four major areas of modern ICU medicine: ventilator management, ventilator weaning, sedation and analgesia, and blood transfusions.
Current Opinion in Critical Care 09/2001; 7(4):304-11. · 2.51 Impact Factor
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ABSTRACT: To develop and validate an instrument for use in the intensive care unit to accurately diagnose delirium in critically ill patients who are often nonverbal because of mechanical ventilation.
Prospective cohort study.
The adult medical and coronary intensive care units of a tertiary care, university-based medical center.
Thirty-eight patients admitted to the intensive care units.
We designed and tested a modified version of the Confusion Assessment Method for use in intensive care unit patients and called it the CAM-ICU. Daily ratings from intensive care unit admission to hospital discharge by two study nurses and an intensivist who used the CAM-ICU were compared against the reference standard, a delirium expert who used delirium criteria from the Diagnostic and Statistical Manual of Mental Disorders (fourth edition). A total of 293 daily, paired evaluations were completed, with reference standard diagnoses of delirium in 42% and coma in 27% of all observations. To include only interactive patient evaluations and avoid repeat-observer bias for patients studied on multiple days, we used only the first-alert or lethargic comparison evaluation in each patient. Thirty-three of 38 patients (87%) developed delirium during their intensive care unit stay, mean duration of 4.2 +/- 1.7 days. Excluding evaluations of comatose patients because of lack of characteristic delirium features, the two critical care study nurses and intensivist demonstrated high interrater reliability for their CAM-ICU ratings with kappa statistics of 0.84, 0.79, and 0.95, respectively (p <.001). The two nurses' and intensivist's sensitivities when using the CAM-ICU compared with the reference standard were 95%, 96%, and 100%, respectively, whereas their specificities were 93%, 93%, and 89%, respectively.
The CAM-ICU demonstrated excellent reliability and validity when used by nurses and physicians to identify delirium in intensive care unit patients. The CAM-ICU may be a useful instrument for both clinical and research purposes to monitor delirium in this challenging patient population.
Critical Care Medicine 08/2001; 29(7):1370-9. · 6.33 Impact Factor
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ABSTRACT: To answer the following questions: Can the digital chest roentgenogram (CXR) be used to differentiate patients' volume status? Do clinical data alter radiologists' accuracy in interpreting the digital CXR?
Prospective cohort study.
Nine adult intensive care units of a tertiary care medical center.
One hundred thirty-five consecutive patients with pulmonary artery catheters, of whom 35 were excluded because of unacceptable pulmonary artery occlusion pressure (PAOP) tracings.
Each patient had a portable, anteroposterior, supine digital CXR. Clinicians evaluated volume status and then measured hemodynamic data within 1 hr of the CXR. Digital CXRs were independently interpreted on two separate occasions (with and without clinical information) by three experienced chest radiologists, and these interpretations were compared with hemodynamic data.
Of the 100 patients, 39 had PAOP >18 mm Hg, whereas 61 had PAOP <18 mm Hg. Radiologists' accuracy in differentiating volume status increased with incorporation of clinical data (56% without vs. 65% with clinical data, p =.009). Using objective receiver operating characteristic-derived cutoffs of 70 mm for vascular pedicle width and 0.55 for cardiothoracic ratio, radiologists' accuracy in differentiating PAOP >18 mm Hg from PAOP <18 mm Hg was 70%. The intrareader and the inter-reader correlation coefficients were very high. The likelihood ratio of the CXR in determining volume status using the objective vascular pedicle width and cardiothoracic ratio measures was 3.1 (95% confidence interval, 1.9-6.0), significantly higher than subjective CXR interpretations with and without clinical data (p <.001).
Differentiating intravascular volume status with portable, supine, digital CXRs may be improved by using objective cutoffs of vascular pedicle width >70 mm and cardiothoracic ratio >0.55 or by incorporating clinical data.
Critical Care Medicine 08/2001; 29(8):1502-12. · 6.33 Impact Factor
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New England Journal of Medicine 05/2001; 344(16):1214. · 53.30 Impact Factor
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G R Bernard,
J L Vincent,
P F Laterre,
S P LaRosa,
J F Dhainaut,
A Lopez-Rodriguez,
J S Steingrub,
G E Garber,
J D Helterbrand, E W Ely,
C J Fisher
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ABSTRACT: Drotrecogin alfa (activated), or recombinant human activated protein C, has antithrombotic, antiinflammatory, and profibrinolytic properties. In a previous study, drotrecogin alfa activated produced dose-dependent reductions in the levels of markers of coagulation and inflammation in patients with severe sepsis. In this phase 3 trial, we assessed whether treatment with drotrecogin alfa activated reduced the rate of death from any cause among patients with severe sepsis.
We conducted a randomized, double-blind, placebo-controlled, multicenter trial. Patients with systemic inflammation and organ failure due to acute infection were enrolled and assigned to receive an intravenous infusion of either placebo or drotrecogin alfa activated (24 microg per kilogram of body weight per hour) for a total duration of 96 hours. The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion. Patients were monitored for adverse events; changes in vital signs, laboratory variables, and the results of microbiologic cultures; and the development of neutralizing antibodies against activated protein C.
A total of 1690 randomized patients were treated (840 in the placebo group and 850 in the drotrecogin alfa activated group). The mortality rate was 30.8 percent in the placebo group and 24.7 percent in the drotrecogin alfa activated group. On the basis of the prospectively defined primary analysis, treatment with drotrecogin alfa activated was associated with a reduction in the relative risk of death of 19.4 percent (95 percent confidence interval, 6.6 to 30.5) and an absolute reduction in the risk of death of 6.1 percent (P=0.005). The incidence of serious bleeding was higher in the drotrecogin alfa activated group than in the placebo group (3.5 percent vs. 2.0 percent, P=0.06).
Treatment with drotrecogin alfa activated significantly reduces mortality in patients with severe sepsis and may be associated with an increased risk of bleeding.
New England Journal of Medicine 04/2001; 344(10):699-709. · 53.30 Impact Factor
