The rise, fall, and future direction of computer-assisted personalized sedation.

PURPOSE OF REVIEW: The first computer-assisted personalized sedation (CAPS) device was developed to address the growing demand for routine endoscopy procedures in the United States in the early 2000s. This review will describe the environment that gave rise to CAPS and summarize the design of that first device. It will then discuss the market forces that led to the fall of CAPS, with sales of the device ending 2 years after commercialization. RECENT FINDINGS: CAPS was initially conceived as a means to enable proceduralists to administer conscious sedation with propofol safely. In the nearly 20 years since its conception, the expectations of patients and proceduralists for endoscopy sedation, have evolved from conscious sedation to deep. Due to the increased risk inherent in deep sedation, future CAPS devices should be tools for anesthesiologists, not proceduralists. SUMMARY: Over $2 billion are spent annually for anesthesia services in routine endoscopic procedures for low-risk patients; a spending rate that is not sustainable. CAPS, in an 'anesthesia oversight' model similar to medical supervision, has a future as a cost-efficient means for anesthesia services to provide sedation in endoscopy and other nonoperating room venues. Anesthesiologists should work with medical device companies and payers to develop a CAPS 'anesthesia oversight' model.

Substantial Increase in Anesthesia Assistance for Outpatient Colonoscopy and Associated Cost Nationwide.

BACKGROUND AND AIMS: The use of anesthesia assistance (AA) for outpatient colonoscopy has been increasing over the past decade, raising concern over its effects on procedure safety, quality, and cost. We performed a nationwide claims-based study to determine regional, patient-related, and facility-related patterns of anesthesia use as well as cost implications of AA for payers. METHODS: We analyzed the Premier Perspective database to identify patients undergoing outpatient colonoscopy at over 600 acute-care hospitals throughout the United States from 2006 through 2015, with or without AA. We used multivariable analysis to identify factors associated with AA and cost. RESULTS: We identified 4,623,218 patients who underwent outpatient colonoscopy. Of these, 1,671,755 (36.2%) had AA; the proportion increased from 16.7% in 2006 to 58.1% in 2015 (P < .001). Factors associated with AA included younger age (odds ratios [ORs], compared to patients 18-39 years old: 0.94, 0.82, 0.77, 0.72, and 0.77 for age groups 40-49 years, 50-59 years, 60-69 years, 70-79 years, and ≥80 years, respectively); and female sex (OR, 0.96 for male patients compared to female patients; 95% CI, 0.95-0.96). Black patients were less likely to receive AA than white patients (OR, 0.81; 95% CI, 0.81-0.82), although this difference decreased with time. The median cost of outpatient colonoscopy with AA was higher among all payers, ranging from $182.43 (95% CI, $180.80-$184.06) higher for patients with commercial insurance to $232.62 (95% CI, $222.58-$242.67) higher for uninsured patients. CONCLUSIONS: In an analysis of a database of patients undergoing outpatient colonoscopy throughout the United States, we found that the use of AA during outpatient colonoscopy increased significantly from 2006 through 2015, associated with increased cost for all payers. The increase in anesthesia use mandates evaluation of its safety and effectiveness in colorectal cancer screening programs.

Continuous Deep Sedation Until Death-a Swiss Death Certificate Study.

BACKGROUND: In the last decade, the number of patients continuously deeply sedated until death increased up to fourfold. The reasons for this increase remain unclear. OBJECTIVE: To identify socio-demographic and clinical characteristics of sedated patients, and concurrent possibly life-shortening medical end-of-life decisions. DESIGN: Cross-sectional death certificate study in German-speaking Switzerland in 2001 and 2013. PARTICIPANTS: Non-sudden and expected deaths (2001: N = 2281, 2013: N = 2256) based on a random sample of death certificates and followed by an anonymous survey on end-of-life practices among attending physicians. MAIN MEASURES: Physicians' reported proportion of patients continuously deeply sedated until death, socio-demographic and clinical characteristics, and possibly life-shortening medical end-of life decisions. KEY RESULTS: In 2013, physicians sedated four times more patients continuously until death (6.7% in 2001; 24.5.5% in 2013). Four out of five sedated patients died in hospitals, outside specialized palliative care units, or in nursing homes. Sedation was more likely among patients younger than 65 (odds ratio 2.24, 95% CI 1.6 to 3.2) and those dying in specialized palliative care (OR 2.2, 95% CI 1.3 to 3.8) or in hospitals (1.7, 95% CI 1.3 to 2.3). Forgoing life-prolonging treatment with the explicit intention to hasten or not to postpone death combined with intensified alleviation of symptoms was very strongly associated with continuous deep sedation (OR 6.8, 95% CI 4.7 to 9.8). CONCLUSIONS: In Swiss clinical practice, continuously deeply sedated patients predominantly died outside specialized palliative care. The increasing trend over time appears to be related to changes in medical end-of-life practice rather than to patient's clinical characteristics.

Palliative sedation in Germany: factors and treatment practices associated with different sedation rate estimates in palliative and hospice care services.

BACKGROUND: Clinical practice of Palliative Sedation (PS) varies between institutions worldwide and sometimes includes problematic practices. Little available research points at different definitions and frameworks which may contribute to uncertainty of healthcare professionals in the application of PS. This analysis investigates what demographic factors and characteristics of treatment practices differ between institutions with high versus low sedation rates estimates in Palliative and Hospice Care in Germany. METHODS: Data sets from 221 organisations from a prior online survey were separated into two sub-groups divided by their estimated sedation rate A) lower/equal to 16% (n = 187; 90.8%) and B) higher than 16% (n = 19; 9.2%) for secondary analysis. Demographic factors and characteristics of PS treatment practices between the two groups were compared using T-Tests and Chi2/ Fisher Exact Tests and considered significant (*) at two-sided p < .05. RESULTS: Organisations in group B report that they discuss PS for a higher proportion of patients (38.5%/10.2%, p < 0.000**), rate agitation more often as an indications for PS (78.9%/ 53.5%, p = 0.050*), and are more likely to use Lorazepam (63.2%/ 37.4%, p = 0.047*), Promethazin (26.3%/ 9.6%, p = 0.044*), and (Es-)Ketamin (31.6%/ 12.8%, p = 0.039*) than representatives in group A. Both groups differ significantly in their allocation of three case scenarios to different types of PS. CONCLUSIONS: Both definitions and patterns of clinical practice between palliative and hospice care representatives show divergence, which may be influenced one by another. A comprehensive framework considering conceptual, clinical, ethical, and legal aspects of different definitions of PS could help to better distinguish between different types and nuances of PS.

Continuous palliative sedation for patients with advanced cancer at a tertiary care cancer center.

BACKGROUND: Palliative sedation (PS) is an intervention to treat refractory symptoms and to relieve suffering at the end of life. Its prevalence and practice patterns vary widely worldwide. The aim of our study was to evaluate the frequency, clinical indications and outcomes of PS in advanced cancer patients admitted to our tertiary comprehensive cancer center. METHODS: We retrospectively studied the use of PS in advanced cancer patients who died between March 1st, 2012 and December 31st, 2014. PS was defined as the use of continuous infusion of midazolam or neuroleptics for refractory symptoms in the end of life. This study was approved by the Research Ethics Committee of our institution (project number 2481-15). RESULTS: During the study period, 552 cancer patients died at the institution and 374 met the inclusion criteria for this study. Main reason for exclusion was death in the Intensive Care Unit. Among all included patients, 54.2% (n = 203) received PS. Patients who received PS as compared to those not sedated were younger (67.8 vs. 76.4 years-old, p < 0.001) and more likely to have a diagnosis of lung cancer (23% vs. 14%, p = 0.028). The most common indications for sedation were dyspnea (55%) and delirium (19.7%) and the most common drugs used were midazolam (52.7%) or midazolam and a neuroleptic (39.4%). Median initial midazolam infusion rate was 0.75 mg/h (interquartile range - IQR - 0.6-1.5) and final rate was 1.5 mg/h (IQR 0.9-3.0). Patient survival (length of hospital stay from admission to death) of those who had PS was more than the double of those who did not (33.6 days vs 16 days, p < 0.001). The palliative care team was involved in the care of 12% (n = 25) of sedated patients. CONCLUSIONS: PS is a relatively common practice in the end-of-life of cancer patients at our hospital and it is not associated with shortening of hospital stay. Involvement of a dedicated palliative care team is strongly recommended if this procedure is being considered. Further research is needed to identify factors that may affect the frequency and outcomes associated with PS.

Anesthesia Service Use During Outpatient Gastroenterology Procedures Continued to Increase From 2010 to 2013 and Potentially Discretionary Spending Remained High.

OBJECTIVES: Previous studies have identified an increasing number of gastroenterology (GI) procedures using anesthesia services to provide sedation, with a majority of these services delivered to low-risk patients. The aim of this study was to update these trends with the most recent years of data. METHODS: We used Medicare and commercial claims data from 2010 to 2013 to identify GI procedures and anesthesia services based on CPT codes, which were linked together using patient identifiers and dates of service. We defined low-risk patients as those who were classified as ASA (American Society of Anesthesiologists) physical status class I or II. For those patients without an ASA class listed on the claim, we used a prediction algorithm to impute an ASA physical status. RESULTS: Over 6.6 million patients in our sample had a GI procedure between 2010 and 2013. GI procedures involving anesthesia service accounted for 33.7% in 2010 and 47.6% in 2013 in Medicare patients, and 38.3% in 2010 and 53.0% in 2013 in commercially insured patients. Overall, as more patients used anesthesia services, total anesthesia service use in low-risk patients increased 14%, from 27,191 to 33,181 per million Medicare enrollees. Similarly, we observed a nearly identical uptick in commercially insured patients from 15,871 to 22,247 per million, an increase of almost 15%. During 2010-2013, spending associated with anesthesia services in low-risk patients increased from US$3.14 million to US$3.45 million per million Medicare enrollees and from US$7.69 million to US$10.66 million per million commercially insured patients. CONCLUSIONS: During 2010 to 2013, anesthesia service use in GI procedures continued to increase and the proportion of these services rendered for low-risk patients remained high.

On the Horizon: The Future of Procedural Sedation.

Sedation plays an integral part in endoscopy. By achieving patient comfort, it allows for a better examination and enhances patient satisfaction. Various medications have been used, propofol being the current favorite. With emphasis on patient safety and quality of endoscopy, various new medications in different combinations are being used to achieve adequate sedation and not escalate the cost of the procedure. With the advent of newer medications and newer modalities to administer these medications, there is need for more specialized training for the endoscopist to feel comfortable while using these medications.

Early deep sedation is associated with decreased in-hospital and two-year follow-up survival.

INTRODUCTION: There is increasing evidence that deep sedation is detrimental to critically ill patients. The aim of this study was to examine effects of deep sedation during the early period after ICU admission on short- and long-term survival. METHODS: In this observational, matched-pair analysis, patients receiving mechanical ventilation that were admitted to ICUs of a tertiary university hospital in six consecutive years were grouped as either lightly or deeply sedated within the first 48 hours after ICU admission. The Richmond Agitation-Sedation Score (RASS) was used to assess sedation depth (light sedation: -2 to 0; deep: -3 or below). Multivariate Cox regression was conducted to investigate the impact of early deep sedation within the first 48 hours of admission on in-hospital and two-year follow-up survival. RESULTS: In total, 1,884 patients met inclusion criteria out of which 27.2% (n = 513) were deeply sedated. Deeply sedated patients had longer ventilation times, increased length of stay and higher rates of mortality. Early deep sedation was associated with a hazard ratio of 1.661 (95% CI: 1.074 to 2.567; P = 0.022) for in-hospital survival and 1.866 (95% CI: 1.351 to 2.576; P < 0.001) for two-year follow-up survival. CONCLUSIONS: Early deep sedation during the first 48 hours of intensive care treatment was associated with decreased in-hospital and two-year follow-up survival. Since early deep sedation is a modifiable risk factor, this data shows an urgent need for prospective clinical trials focusing on light sedation in the early phase of ICU treatment.

Early sedation and clinical outcomes of mechanically ventilated patients: a prospective multicenter cohort study.

INTRODUCTION: Sedation overuse is frequent and possibly associated with poor outcomes in the intensive care unit (ICU) patients. However, the association of early oversedation with clinical outcomes has not been thoroughly evaluated. The aim of this study was to assess the association of early sedation strategies with outcomes of critically ill adult patients under mechanical ventilation (MV). METHODS: A secondary analysis of a multicenter prospective cohort conducted in 45 Brazilian ICUs, including adult patients requiring ventilatory support and sedation in the first 48 hours of ICU admissions, was performed. Sedation depth was evaluated after 48 hours of MV. Multivariate analysis was used to identify variables associated with hospital mortality. RESULTS: A total of 322 patients were evaluated. Overall, ICU and hospital mortality rates were 30.4% and 38.8%, respectively. Deep sedation was observed in 113 patients (35.1%). Longer duration of ventilatory support was observed (7 (4 to 10) versus 5 (3 to 9) days, P = 0.041) and more tracheostomies were performed in the deep sedation group (38.9% versus 22%, P = 0.001) despite similar PaO2/FiO2 ratios and acute respiratory distress syndrome (ARDS) severity. In a multivariate analysis, age (Odds Ratio (OR) 1.02; 95% confidence interval (CI) 1.00 to 1.03), Charlson Comorbidity Index >2 (OR 2.06; 95% CI, 1.44 to 2.94), Simplified Acute Physiology Score 3 (SAPS 3) score (OR 1.02; CI 95%, 1.00 to 1.04), severe ARDS (OR 1.44; CI 95%, 1.09 to 1.91) and deep sedation (OR 2.36; CI 95%, 1.31 to 4.25) were independently associated with increased hospital mortality. CONCLUSIONS: Early deep sedation is associated with adverse outcomes and constitutes an independent predictor of hospital mortality in mechanically ventilated patients.

Recent advances and contributions to procedural sedation with considerations for the future.

As the demand for sedation services have increased, the delivery of sedation has shifted from the operating room setting to areas distant to the operating room, both within and outside the hospital setting. Sedation delivery is not monopolized by any one specialty, but rather is being delivered by anesthesiologists as well as non-anesthesiologists. As the field of sedation burgeons and multi-specialists enter the realm of meeting the demands, so also have the politics increased. Unfortunately, the choice of sedative agents has not increased in parallel with the demand for sedation. Over the past decade, there has been a paucity of new introductions for procedural sedation. Rather, new formulations of approved agents are being reexamined. The safe, efficient and predictable delivery of sedation remains at the forefront of discussion and review worldwide. This review will explore the recent, significant and noteworthy contributions to the field of sedation.

Sedation and mobility: changing the paradigm.

A large fraction of intensive care unit (ICU) patients with respiratory failure who survive their critical illness leave the hospital with substantial neuromuscular weakness. In light of this reality, a shift in the approach to critical care management has begun. This viewpoint has broadened the perspective of ICU care providers beyond the narrow goal of leaving the ICU alive to a broader notion focused on minimizing the complications that accompany the inherent noxious nature of ICU care. Mobilization of mechanically ventilated patients is feasible, safe, and carries the potential for tremendous benefit for our patients.

Time to wake up the patients in the ICU: a crazy idea or common sense?

With the first generation of ventilators, it was often necessary to sedate patients to avoid dyssynchrony between patient and ventilator. The standard treatment of patients in need of mechanical ventilation has therefore traditionally included sedation. Modern ventilators are able to simulate the patients breathing efforts to a higher degree, and therefore, deep sedation is no longer necessary. In the last decade, support has grown for a reduction in the use of sedation. The focus has been placed on the correlation between the depth of sedation and the length of mechanical ventilation. It has been shown that a daily wake up trial reduced the time that patients were dependent on mechanical ventilation. Additionally, it has been shown that combining both a spontaneous breathing trial and a daily wake up trial reduced the mechanical ventilation time compared to a spontaneous breathing trial alone. We have recently shown in a randomized study that the use of no sedation, compared to the standard treatment with sedation and a daily wake up trial, reduced the time that patients required mechanical ventilation, the length of the patients' stay in the intensive care unit, and the total length of the hospital stay. All evidence indicates that the use of sedative drugs should be reduced, patients should be mobilized, and each patient's needs should be evaluated on a daily basis to optimize the care of each individual patient.