Richmond Agitation-Sedation Scale Assessment Research Articles

Discussion Guide for the May Article.

Discussion Guide for the May Article.

Multicenter International Cohort Validation of a Modified Sequential Organ Failure Assessment Score Using the Richmond Agitation-sedation Scale.

In a multicenter, international cohort, we aimed to validate a modified Sequential Organ Failure Assessment (mSOFA) using the Richmond Agitation-Sedation Scale, hypothesized as comparable to the Glasgow Coma Scale (GCS)-based Sequential Organ Failure Assessment (SOFA). The SOFA score, whose neurologic component is based on the GCS, can predict intensive care unit (ICU) mortality. But, GCS is often missing in lieu of other assessments, such as the also reliable and validated Richmond Agitation Sedation Scale (RASS). Single-center data suggested an RASS-based SOFA (mSOFA) predicted ICU mortality. Our nested cohort within the prospective 2016 Fourth International Study of Mechanical Ventilation contains 4120 ventilated patients with daily RASS and GCS assessments (20,023 patient-days, 32 countries). We estimated GCS from RASS via a proportional odds model without adjustment. ICU mortality logistic regression models and c-statistics were constructed using SOFA (measured GCS) and mSOFA (measured RASS-estimated GCS), adjusted for age, sex, body-mass index, region (Europe, USA-Canada, Latin America, Africa, Asia, Australia-New Zealand), and postoperative status (medical/surgical). Cohort-wide, the mean SOFA=9.4+/-2.8 and mean mSOFA = 10.0+/-2.3, with ICU mortality = 31%. Mean SOFA and mSOFA similarly predicted ICU mortality (SOFA: AUC = 0.784, 95% CI = 0.769-0.799; mSOFA: AUC = 0.778, 95% CI = 0.763-0.793, P = 0.139). Across models, other predictors of mortality included higher age, female sex, medical patient, and African region (all P < 0.001). We present the first SOFA modification with RASS in a "real-world" international cohort. Estimating GCS from RASS preserves predictive validity of SOFA to predict ICU mortality. Alternative neurologic measurements like RASS can be viably integrated into severity of illness scoring systems like SOFA.

Effect of Flumazenil on Hypoactive Delirium in the ICU: A Double-Blind, Placebo-Controlled Pilot Study.

This was a single-center, double-blinded, randomized placebo-controlled pilot study. Adult ICUs at a large academic medical center in the United States. Adult, critically ill patients with benzodiazepine exposure and hypoactive delirium based on the Confusion Assessment Method-ICU and Richmond Agitation Sedation Scale assessments were considered for enrollment. Patients received a test dose of flumazenil starting at 0.1 mg intravenously and titrated up every 5 minutes by 0.1 mg increments up to a maximum total dose of 2 mg. Patients who demonstrated a Richmond Agitation Sedation Scale score increase of greater than 1 point were considered responders and randomized to flumazenil (0.05-0.3 mg/hr) or placebo infusion for up to 72 hours. Confusion Assessment Method-ICU scores were assessed twice daily for resolution of delirium. The trial was stopped early based on the observed size effect and power analysis. Twenty-two of the 25 patients responded to the flumazenil test dose (88%). The median number of delirium-free days alive without coma within 14 days of enrollment was similar between the two infusion groups (12.7 vs 9.2; p = 0.19). There was no difference in the probability of delirium resolution within the first 14 days with 90% versus 70% in the flumazenil and placebo groups, respectively (p = 0.2). There was no statistical difference (odds ratio, 0.17; 95% CI, 0.022-1.23; p = 0.079) in delirium- and coma-free days at the end of the study drug infusion. There was no difference between groups in ICU length of stay (7.8 ± 4.8 vs 7 ± 8; p = 0.74). No serious adverse events occurred. This study found that flumazenil test dose and infusion present a potential option for hypoactive delirium associated with benzodiazepine exposure; however, the possible benefit is unknown. Larger studies are warranted to further evaluate these findings.

Implementing the Richmond Agitation-Sedation Scale in a respiratory critical care unit: a best practice implementation project.

Adequate sedation can lead to patient-ventilator synchrony, facilitation of treatment, and decreased physical and psychological discomfort for patients with respiratory failure in the intensive care unit (ICU). The Richmond Agitation-Sedation Scale (RASS) is considered to be the most appropriate tool in sedation assessment. This aim of this project was to implement evidence-based recommendations for sedation assessment using the RASS in mechanically ventilated patients in the ICU. This implementation project was conducted in an ICU at a tertiary medical center in Taiwan. Using the JBI Practical Application of Clinical Evidence System software, a baseline audit was conducted in the ICU, followed by an identification of barriers of RASS assessment and an implementation of management of strategies to improve the consistency of sedation assessment. Results of the baseline audit showed that four of the six selected criteria had 0% compliance. Following the implementation of the strategies, which included education, visual management and development of a "RASS Reminder Card", there was an improvement in all the criteria audited, with each criterion achieving 83-100% of compliance. The project successfully improved the implementation of RASS assessment in the respiratory ICU. Following the development and implementation of evidence-based resources, a high level of compliance was achieved for nurses using the RASS in the ICU to assess sedation in patients with a ventilator.

Multi-modal Educational Curriculum to Improve Richmond Agitation-sedation Scale Inter-rater Reliability in Pediatric Patients.

Introduction:The Richmond Agitation-sedation Scale (RASS) is a reliable and valid scale for assessing sedation in critically ill pediatric patients. This investigation evaluates the inter-rater reliability of the RASS in mechanically ventilated pediatric patients before and after an educational intervention.Methods:This prospective, interventional quality improvement study was completed in a 20-bed pediatric intensive care unit from July 2013 to July 2014. Children 0–18 years of age requiring mechanical ventilation and receiving sedative or analgesic medications were eligible. Staff completed simultaneous paired RASS assessments in 3 phases: baseline, after educational intervention, and maintenance.Results:Staff completed 347 paired assessments on 45 pediatric intensive care unit patients: 49 in the baseline phase, 228 in the postintervention phase, and 70 in the maintenance phase. There was a significant increase in the weighted κ after the intervention, from 0.56 (95% CI, 0.39–0.72) to 0.86 (95% CI, 0.77–0.95; P < 0.001). The improvement was maintained months later with weighted κ 0.78 (95% CI, 0.61–0.94). In subgroup analysis, there was an increase in weighted κ in patients less than 1 year of age (0.41–0.87) and those with developmental delay (0.49–0.84).Conclusions:The RASS is a reliable tool for sedation assessment in mechanically ventilated, sedated pediatric patients after implementation of an educational intervention. It is also reliable in patients less than 12 months of age and patients with developmental delay. The ability to easily educate providers to utilize a valid, reliable sedation tool is an important step toward using it to provide consistent care to optimize sedation.

S87. Sedation prediction using EEG spectrogram in ICU patients

Most mechanically ventilated ICU patients receive sedatives to relieve pain and anxiety, and to provide cardiopulmonary stability. Unfortunately, both excessive and insufficient sedation are common. Brain monitors that track electroencephalogram (EEG) features have been proposed as a real-time, physiologically-based alternative to clinical sedation assessments. However, existing monitors have been tested almost exclusively in the surgical setting, without being optimized for ICU patients. Patients: We analyzed prospectively collected data from 115 mechanically ventilated patients receiving usual ICU care. The Richmond agitation sedation scale (RASS), assessed every 2 h, provides reference sedation levels. In the present work, we consider only assessments with RASS −5 and −4 (deeply sedated) vs −1 and 0 (not sedated). In total, there are 664 RASS assessments. The dataset is split into 69 training, 23 validation and 23 testing patients. Label denoising: RASS assessments are sometimes recorded after a delay or in anticipation of a change in the level of consciousness following adjustment in sedative infusion rate. To reduce such “annotation noise”, before training a classifier we first “denoise” EEG segments whose spectra have a different label than the 10 most similar training segments.Classifier training and testing: We extract EEG power spectra from the 10 min period preceding each RASS assessment, using 10s windows sliding windows spaced 2s apart. The sequence of spectra is used to train a recurrent neural network (LSTM), which performs binary classification (RASS −5 and −4 vs −1 and 0). Performance is measured by area the under the receiver operator curve (AUC). The reported results are the average performance on the testing set from 10 random splits of patients. Strict separation of training and validation data from testing data is maintained throughout all experiments. The label denoising procedure alters 15% of RASS scores. The AUC in the testing set is 0.91 (SD 0.02). Visualization of the EEG spectrograms reveals lower total power and higher relative delta power for episodes of RASS −5 and −4; and higher total power and higher relative beta power for RASS −1 and 0. Despite heterogeneous medical conditions and varying severity of medical illness in our ICU cohort, our model learns to accurately discriminate deep sedation (RASS −5 and −4) from the awake state (RASS −1and 0). The classifier achieves AUC at 0.91 in a patient-independent manner. The use of recurrent network architecture allows our model to take advantage of long-range temporal information in the EEG, and will allow the extension to take pharmacokinetics and pharmacodynamics information into account, which may further enhance performance and robustness.

Feasibility of continuous sedation monitoring in critically ill intensive care unit patients using the NeuroSENSE WAVCNS index.

Sedation in the intensive care unit (ICU) is challenging, as both over- and under-sedation are detrimental. Current methods of assessment, such as the Richmond Agitation Sedation Scale (RASS), are measured intermittently and rely on patients' behavioral response to stimulation, which may interrupt sleep/rest. A non-stimulating method for continuous sedation monitoring may be beneficial and allow more frequent assessment. Processed electroencephalography (EEG) monitors have not been routinely adopted in the ICU. The aim of this observational study was to assess the feasibility of using the NeuroSENSE™ monitor for EEG-based continuous sedation assessment. With ethical approval, ICU patients on continuous propofol sedation were recruited. Depth-of-hypnosis index (WAVCNS) values were obtained from the NeuroSENSE. Bedside nurses, blinded to the NeuroSENSE, performed regular RASS assessments and maintained the sedation regimen as per standard of care. Participants were monitored throughout the duration of their propofol infusion, up to 24h. Fifteen patients, with median [interquartile range] age of 57 [52-62.5] years were eachmonitored for a duration of 9.0 [5.7-20.1] h. Valid WAVCNS values were obtained for 89% [66-99] of monitoring time and were widely distributed within and between individuals, with 6% [1-31] spent < 40 (very deep), and 3% [1-15] spent > 90 (awake). Significant EEG suppression was detected in 3/15 (20%) participants. Observed RASS matched RASS goals in 36/89 (40%) assessments. The WAVCNS variability, and incidence of EEG suppression, highlight the limitations of using RASS as a standalone sedation measure, and suggests potential benefit of adjunct continuous brain monitoring.

Does Neurofunction Monitoring Enhance Nursing Confidence and Comfort?

Despite advances in the science of sedation and pain assessment, few studies have examined the impact of various assessment tools on nursing confidence. This study examines how bispectral index monitoring impacts nursing confidence in the assessment and comfort in medication administration based on that assessment. In this prospective observational Quality Improvement project, nurses using bispectral index (BIS) and the Richmond Agitation Sedation Scale (RASS) were randomly selected to complete a self-assessment survey intended to measure their personal confidence and comfort regarding care they were providing for a specific patient on the day the survey was completed. From 110 nurse surveys, nurses had higher confidence assessing pain and sedation when BIS monitor was used in concert with RASS assessments for patients with neuromuscular blockade agents. There was no different in confidence in- nor comfort with- sedation and pain assessments for patients not receiving neuromuscular blockade agents.

Bispectral Index Can Reliably Detect Deep Sedation in Mechanically Ventilated Patients: A Prospective Multicenter Validation Study.

Excessively deep sedation is prevalent in mechanically ventilated patients and often considered suboptimal. We hypothesized that the bispectral index (BIS), a quantified electroencephalogram instrument, would accurately detect deep levels of sedation. We prospectively enrolled 90 critically ill mechanically ventilated patients who were receiving sedation. The BIS was monitored for 24 hours and compared with the Richmond Agitation Sedation Scale (RASS) evaluated every 4 hours. Deep sedation was defined as a RASS of -3 to -5. Threshold values of baseline BIS (the lowest value before RASS assessment) and stimulated BIS (the highest value after standardized assessment) for detecting deep sedation were determined in a training set (45 patients, 262 RASS assessments). Diagnostic accuracy was then analyzed in a validation set (45 patients, 264 RASS assessments). Deep sedation was only prescribed in 6 (6.7%) patients, but 76 patients (84.4%) had at least 1 episode of deep sedation. Thresholds for detecting deep sedation of 50 for baseline and 80 for stimulated BIS were identified, with respective areas under the receiver-operating characteristic curve of 0.771 (95% confidence interval, 0.714-0.828) and 0.805 (0.752-0.857). The sensitivity and specificity of baseline BIS were 94.0% and 66.5% and of stimulated BIS were 91.0% and 66.5%. When baseline and stimulated BIS were combined, the sensitivity, specificity, and clinical utility index were 85.0% (76.1%-91.1%), 85.9% (79.5%-90.7%), and 66.9% (57.8%-76.0%), respectively. Combining baseline and stimulated BIS may help detect deep sedation in mechanically ventilated patients.

Analgesia-based sedation

Analgesia-based sedation

Utility of the Richmond Agitation-Sedation Scale in evaluation of acute neurologic dysfunction in the intensive care unit.

Utility of the Richmond Agitation-Sedation Scale in evaluation of acute neurologic dysfunction in the intensive care unit.

Impact of Quetiapine Treatment on Duration of Hypoactive Delirium in Critically Ill Adults: A Retrospective Analysis

Because delirium remains a common consequence of critical illness, and reducing its duration has been shown to have a positive impact on patient outcomes during and after an intensive care unit (ICU) stay, we sought to determine whether treatment of hypoactive delirium with quetiapine reduces the duration of delirium compared with no pharmacologic treatment. Retrospective cohort study. Three medical-surgical ICUs within the two main campuses of an academic tertiary care hospital system. A total of 113 adults with documented hypoactive delirium during an ICU length of stay (LOS) of at least 72hours between August 2013 and September 2014; 52 patients received at least one dose of quetiapine during their hypoactive delirium course, and 61 patients received no pharmacologic delirium treatment. Patients were screened for hypoactive delirium using the Confusion Assessment Method-ICU (CAM-ICU) and the Richmond Agitation Sedation Scale (RASS). The primary outcome was time to first resolution of delirium, and secondary outcomes included ICU and hospital LOS, and duration of mechanical ventilation. To assess potential adverse effects of quetiapine, the number of RASS assessments deeper than goal and the total number of RASS assessments documented during the delirium course were recorded for all patients. Daily progress notes and discharge documentation were surveyed to assess for new onset of extrapyramidal symptoms or torsade de pointes. Median duration of hypoactive delirium was shorter in the quetiapine-treated group compared with the no-quetiapine group (1.5 vs 2.0days, p=0.04), and time to extubation after screening positive for delirium trended favorably toward quetiapine-treated patients (3 vs 5days, p=0.08). There were no significant differences in ICU or hospital LOS, and safety outcomes were similar between groups. In this mixed ICU population, treatment of hypoactive delirium with quetiapine was safe and reduced the duration of delirium compared with standard care alone. Prospective placebo-controlled studies are needed to further assess the role of antipsychotics in hypoactive delirium.

Impaired arousal at initial presentation predicts 6-month mortality: an analysis of 1084 acutely ill older patients.

Impaired arousal signifies underlying brain dysfunction, but its clinical significance outside the intensive care unit remains unclear. We sought to determine if impaired arousal at initial presentation was associated with higher 6-month mortality and if this relationship existed in the absence of delirium. Prospective cohort study. An emergency department located within an academic, tertiary care hospital. A total of 1084 noncomatose patients who were aged 65 years or older. The Richmond Agitation-Sedation Scale (RASS) is a 10-second arousal scale; a score of 0 indicates normal arousal. Cox proportional hazard regression was performed adjusting for patient characteristics, admission status, and psychoactive medication administration. To determine if impaired arousal in the absence of delirium was associated with 6-month mortality, Cox proportional hazard regression was performed in a subset of 406 patients who received a psychiatric assessment; the inverse weighted propensity score method was used to minimize residual confounding. Hazard ratios (HR) with their 95% confidence intervals (95% CI) were reported. Patients with impaired arousal were 73% more likely to die within 6 months (HR: 1.73, 95% CI: 1.21-2.49). Even in the absence of delirium, patients with an abnormal RASS were more likely to die within 6 months (HR: 2.20, 95% CI: 1.10-4.41). Impaired arousal at initial presentation is an independent predictor of death within 6 months in a diverse group of acutely ill older patients, even in the absence of delirium. Routine RASS assessment of arousal during clinical care may be warranted as it correlates with prognosis.

Improved Analgesia, Sedation, and Delirium Protocol Associated with Decreased Duration of Delirium and Mechanical Ventilation

Introduction of sedation protocols has been associated with improved patient outcomes. It is not known if an update to an existing high-quality sedation protocol, featuring increased patient assessment and reduced benzodiazepine exposure, is associated with improved patient process and outcome quality metrics. This was an observational before (n = 703) and after (n = 780) cohort study of mechanically ventilated patients in a 24-bed trauma-surgical intensive care unit (ICU) from 2009 to 2011. The three main protocol updates were: (1) requirement to document Richmond Agitation Sedation Scale (RASS) scores every 4 hours, (2) requirement to document Confusion Assessment Method-ICU (CAM ICU) twice daily, and (3) systematic, protocolized deescalation of excess sedation. Multivariable linear regression was used for the primary analysis. The primary outcome was the duration of mechanical ventilation. Prespecified secondary endpoints included days of delirium; the frequency of patient assessment with the RASS and CAM-ICU instruments; benzodiazepine dosing; durations of mechanical ventilation, ICU stay, and hospitalization; and hospital mortality and ventilator associated pneumonia rate. Patients in the updated protocol cohort had 1.22 more RASS assessments per day (5.38 vs. 4.16; 95% confidence interval [CI], 1.05-1.39; P < 0.01) and 1.15 more CAM-ICU assessments per day (1.49 vs. 0.35; 95% CI, 1.08-1.21; P < 0.01) than the baseline cohort. The mean hourly benzodiazepine dose decreased by 34.8% (0.08 mg lorazepam equivalents/h; 0.15 vs. 0.23; P < 0.01). In the multivariable model, the median duration of mechanical ventilation decreased by 17.6% (95% CI, 0.6-31.7%; P = 0.04). The overall odds ratio of delirium was 0.67 (95% CI, 0.49-0.91; P = 0.01) comparing updated versus baseline cohort. A 12.4% reduction in median duration of ICU stay (95% CI, 0.5-22.8%; P = 0.04) and a 14.0% reduction in median duration of hospitalization (95% CI, 2.0-24.5%; P = 0.02) were also seen. No significant association with mortality (odds ratio, 1.18; 95% CI, 0.80-1.76; P = 0.40) was seen. Implementation of an updated ICU analgesia, sedation, and delirium protocol was associated with an increase in RASS and CAM-ICU assessment and documentation; reduced hourly benzodiazepine dose; and decreased delirium and median durations of mechanical ventilation, ICU stay, and hospitalization.

Early Goal-Directed Sedation Versus Standard Sedation in Mechanically Ventilated Critically Ill Patients

To assess the feasibility and safety of delivering early goal-directed sedation compared with standard sedation. Pilot prospective, multicenter, randomized, controlled trial. Six ICUs. Critically ill adults mechanically ventilated for greater than 24 hours. Patients randomized to early goal-directed sedation received a dexmedetomidine-based algorithm targeted to light sedation (Richmond Agitation Sedation Score of -2 to 1). Patients randomized to standard sedation received propofol and/or midazolam-based sedation as clinically appropriate. The main feasibility outcomes were time to randomization and proportion of Richmond Agitation Sedation Score assessments in the first 48 hours in the light and deep sedation range. Safety outcomes were delirium-free days, vasopressor and physical restraints use, and device removal. Randomization occurred within a median (interquartile range) of 1.1 hours (0.46-1.9) after intubation or ICU admission for out of ICU intubation. Patients in the early goal-directed sedation (n = 21) mean (SD) Acute Physiology and Chronic Health Evaluation II score was 20.2 (6.2) versus 18.6 (8.8; p = 0.53) in the standard sedation (n = 16). A significantly higher proportion of patients was lightly sedated on days 1, 2, and 3 (12/19 [63.2%], 19/21 [90.5%], and 18/20 [90%] vs 2/14 [14.3%], 8/15 [53.3%], and 9/15 [60%]; p = 0.005, 0.011, 0.036) and more Richmond Agitation Sedation Scale assessments between (-2 and 1), in the first 48 hours (203/307 [66%] versus (74/197 [38%]; p = 0.01) in the early goal-directed sedation versus standard sedation, respectively. Early goal-directed sedation patients received midazolam on 6 of 173 (3.5%) versus 4 of 114 (3.5%) standard sedation patient-days when dexmedetomidine was given. Propofol was given to 16 of 21 (76%) of early goal-directed sedation versus 16 of 16 (100%) of standard sedation patients (p = 0.04). Early goal-directed sedation patients had 101 of 175 (58%) versus 54 of 114 (47%; p = 0.27) delirium-free days and required significantly less physical restraints 1 (5%) versus 5 (31%; p = 0.03) than standard sedation patients. There were no differences in vasopressor use and self-extubation. Delivery of early goal-directed sedation was feasible, appeared safe, achieved early light sedation, minimized benzodiazepines and propofol, and decreased the need for physical restraints. The findings of this pilot study justify further investigation of early goal-directed sedation.

Comparison and Agreement Between the Richmond Agitation-Sedation Scale and the Riker Sedation-Agitation Scale in Evaluating Patients' Eligibility for Delirium Assessment in the ICU

Delirium evaluation in patients in the ICU requires the use of an arousal/sedation assessment tool prior to assessing consciousness. The Richmond Agitation-Sedation Scale (RASS) and the Riker Sedation-Agitation Scale (SAS) are well-validated arousal/sedation tools. We sought to assess the concordance of RASS and SAS assessments in determining eligibility of patients in the ICU for delirium screening using the confusion assessment method for the ICU (CAM-ICU). We performed a prospective cohort study in the adult medical, surgical, and progressive (step-down) ICUs of a tertiary care, university-affiliated, urban hospital in Indianapolis, Indiana. The cohort included 975 admissions to the ICU between January and October 2009. The outcome measures of interest were the correlation and agreement between RASS and SAS measurements. In 2,469 RASS and SAS paired screens, the rank correlation using the Spearman correlation coefficient was 0.91, and the agreement between the two screening tools for assessing CAM-ICU eligibility as estimated by the κ coefficient was 0.93. Analysis showed that 70.1% of screens were eligible for CAM-ICU assessment using RASS (7.1% sedated [RASS −3 to −1]; 62.6% calm [0]; and 0.4% restless, agitated [+1 to +3]), compared with 72.1% using SAS (5% sedated [SAS 3]; 66.5% calm [4]; and 0.6% anxious, agitated [5, 6]). In the mechanically ventilated subgroup, RASS identified 19.1% CAM-ICU eligible patients compared with 24.6% by SAS. The correlation coefficient in this subgroup was 0.70 and the agreement was 0.81. Both SAS and RASS led to similar rates of delirium assessment using the CAM-ICU.

Delirium and Sedation Recognition Using Validated Instruments: Reliability of Bedside Intensive Care Unit Nursing Assessments from 2007 to 2010

ObjectivesTo describe the reliability and sustainability of delirium and sedation measurements of bedside intensive care unit (ICU) nurses.DesignProspective cohort study.SettingA tertiary care academic medical center.ParticipantsFive hundred ten ICU patients from 2007 to 2010; 627 bedside nurses.MeasurementsBedside nurses and well‐trained reference‐rater research nurses independently measured delirium and sedation levels in routine care. Bedside nurses were instructed to use the Confusion Assessment Method for the Intensive Care Unit (CAM‐ICU) every 12 hours to measure delirium and the Richmond Agitation‐Sedation Scale (RASS) every 4 hours to measure sedation. CAM‐ICU and RASS assessment agreement were computed using weighted kappa statistics across the entire population and subgroups (e.g., ICU type). Sensitivity and specificity of bedside nurse identification of delirium were calculated to understand sources of discordance.ResultsSix thousand one hundred ninety‐eight CAM‐ICU and 6,880 RASS measurement pairs obtained on 3,846 patient‐days. For CAM‐ICU measurements, agreement between bedside and research nurses was substantial (weighted kappa = 0.67, 95% confidence interval (CI) = 0.66–0.70) and stable over 3 years of data collection. RASS measures also demonstrated substantial agreement (weighted kappa = 0.66, 95% CI = 0.64–0.68), which was stable across all years of data collection. The sensitivity of delirium nurse assessments was 0.81 (95% CI = 0.78–0.83), and the specificity was 0.81 (95% CI = 0.78–0.85).ConclusionBedside nurse measurements of delirium and sedation are sustainable and reliable sources of information. These measures can be used for clinical decision‐making, quality improvement, and quality measurement activities.

Informed consent in the critically ill: A two-step approach incorporating delirium screening*

Sedation-agitation and delirium are common in critically ill patients and may be important barriers to informed consent. We describe a two-step process for informed consent and evaluate the natural history of patients' competency by repeated application of this process during their hospitalization. Observational study. Nine intensive care units (ICUs) in three teaching hospitals in Baltimore, MD. One hundred fifty patients with acute lung injury. Two-step process involving objective evaluation with Richmond Agitation-Sedation Scale (RASS) and Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) (step 1), followed by traditional assessment for competency (step 2) in those patients passing step 1. RASS and CAM-ICU assessments (during ICU stay, at consent and hospital discharge); cumulative proportion of patients providing consent at extubation and at ICU and hospital discharge. Of 150 patients, 86 (57%) survived and 77 (90% of survivors) provided consent. Patients were delirious/deeply sedated in 89% of daily assessments during mechanical ventilation. By extubation, 31 (44%) patients passed step 1 and 8 (11%) passed step 2 and were consented. By ICU and hospital discharge, these numbers were 50 (58%) and 18 (21%), and 81 (94%) and 67 (78%), respectively. The median (interquartile range) time to patient consent after acute lung injury diagnosis was 15 (9-28) days. More than three fourths of critically ill patients are unable to provide informed consent throughout their ICU stay, even after extubation. Sedation-agitation and delirium are common barriers to consent. A two-step consent process, using validated instruments for sedation-agitation and delirium, provides a means of rapidly screening critically ill patients before a more detailed traditional assessment of competency is conducted.