Enteral versus intravenous approach for the sedation of critically ill patients: a randomized and controlled trial.

BACKGROUND: ICU patients must be kept conscious, calm, and cooperative even during the critical phases of illness. Enteral administration of sedative drugs might avoid over sedation, and would be as adequate as intravenous administration in patients who are awake, with fewer side effects and lower costs. This study compares two sedation strategies, for early achievement and maintenance of the target light sedation. METHODS: This was a multicenter, single-blind, randomized and controlled trial carried out in 12 Italian ICUs, involving patients with expected mechanical ventilation duration > 72 h at ICU admission and predicted mortality > 12% (Simplified Acute Physiology Score II > 32 points) during the first 24 h on ICU. Patients were randomly assigned to receive intravenous (midazolam, propofol) or enteral (hydroxyzine, lorazepam, and melatonin) sedation. The primary outcome was percentage of work shifts with the patient having an observed Richmond Agitation-Sedation Scale (RASS) = target RASS ±1. Secondary outcomes were feasibility, delirium-free and coma-free days, costs of drugs, length of ICU and hospital stay, and ICU, hospital, and one-year mortality. RESULTS: There were 348 patients enrolled. There were no differences in the primary outcome: enteral 89.8% (74.1-100), intravenous 94.4% (78-100), p = 0.20. Enteral-treated patients had more protocol violations: n = 81 (46.6%) vs 7 (4.2%), p < 0.01; more self-extubations: n = 14 (8.1%) vs 4 (2.4%), p = 0.03; a lighter sedative target (RASS = 0): 93% (71-100) vs 83% (61-100), p < 0.01; and lower total drug costs: 2.39 (0.75-9.78) vs 4.15 (1.20-20.19) €/day with mechanical ventilation (p = 0.01). CONCLUSIONS: Although enteral sedation of critically ill patients is cheaper and permits a lighter sedation target, it is not superior to intravenous sedation for reaching the RASS target. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01360346 . Registered on 25 March 2011.

Development and validation of the PROcedural Sedation Assessment Survey (PROSAS) for assessment of procedural sedation quality.

BACKGROUND: More than 20 million invasive procedures are performed annually in the United States. The vast majority are performed with moderate sedation or deep sedation, yet there is limited understanding of the drivers of sedation quality and patient satisfaction. Currently, the major gap in quality assurance for invasive procedures is the lack of procedural sedation quality measures. OBJECTIVE: To develop and validate a robust, patient-centered measure of procedural sedation quality, the PROcedural Sedation Assessment Survey (PROSAS). DESIGN: Through a series of interviews with patients, proceduralists, nurses, anesthesiologists, and an interactive patient focus group, major domains influencing procedural sedation quality were used to create a multipart survey. The pilot survey was administered and revised in sequential cohorts of adults receiving moderate sedation for GI endoscopy. After revision, the PROSAS was administered to a validation cohort. SETTING: GI endoscopy unit. PATIENTS: A expert panel of proceduralists, nurses, and anesthesiologists, an initial survey development cohort of 40 patients, and a validation cohort of 858 patients undergoing sedation for outpatient GI endoscopy with additional surveys completed by the gastroenterologist, procedure nurse, and recovery nurse. MAIN OUTCOMES AND MEASUREMENTS: Survey characteristics of the PROSAS. RESULTS: Patients were able to independently complete the PROSAS after procedural sedation before discharge. Of the patients, 91.6% reported minimal discomfort; however, 8.4% of patients reported significant discomfort and 2.4% of patients experienced hemodynamic and/or respiratory instability. There was a high correlation between patient-reported intraprocedure discomfort and both clinician assessments of procedural discomfort and patient recall of procedural pain 24 to 48 hours post procedure (P < .001 for all), suggesting high external validity. LIMITATIONS: Single-center study, variability of sedation technique between providers, inclusion of patients with chronic pain taking analgesics. CONCLUSIONS: The PROSAS is a clinically relevant, patient-centered, easily administered instrument that allows for standardized evaluation of procedural sedation quality. The PROSAS may be useful in both research and clinical settings.

Procedural sedation and implications for quality and risk management.

A successful procedural sedation program requires a robust institutional policy backed by a solid educational program and an administrative structure. Given the nature of the services provided, combined with the growth in complexity of both patients and procedures, sedation presents a potential liability for both the provider and the institution. A sedation program is built with a multidisciplinary team of experts representing all stakeholders: healthcare providers, risk and quality improvement managers, and facility administration. An institutional procedural sedation policy should be based on nationally and state recognized practice requirements and guidelines. Clinical care must be supported with a robust risk and quality structure built within the program to ensure best practice at the point of care.

Sedation-associated complications in endoscopy are not reduced significantly by implementation of the German S-3-guideline and occur in a severe manner only in patients with ASA class III and higher.

INTRODUCTION: The German guideline for sedation in gastrointestinal endoscopy was published in 2008. Several recommendations in this guideline, especially concerning staffing and structural requirements for sedation, have low evidence and therefore are subject to discussion in the field. AIM: Comparison of endoscopic complications in a department specialized for gastrointestinal and pulmological diseases before and after implementation of the German guideline grouped in sedation-associated and non-sedation-associated complications. METHODS: Prospective documentation of complications with retrospective analysis of two patient groups (before guideline: 1.5.2008-30.4.2010; after guideline: 1.5.2010-30.4.2012) at which the sedation technique remained the same (balanced propofol sedation, BPS). RESULTS: Both investigation periods covered almost 7000 procedures. Interventional and general complications were nonsignificantly elevated in the latter group (1.27% before vs. 1.55% after guideline, p = 0.08). Saturation decline (in both groups 0.26%) was unchanged, and circulation-associated complications (0.27% vs. 0.13%, p = 0.07) were reduced nonsignificantly. Necessity for the administration of flumazenil and for intensive care monitoring was reduced in a nonsignificant manner after the implementation of the guideline. Severe complications (reanimation, apnea, and death) were unchanged, and no patient with ASA I-II suffered from a severe complication. Propofol consumption was higher after guideline implementation. CONCLUSIONS: The recommendations of the new German sedation guideline do not significantly reduce complications in endoscopic procedures. Especially, procedures involving patients with ASA classes I and II do not require an additional staff member solely for sedation. Prospective randomized studies might be necessary to optimize the utilization of resources.

Guideline for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures.

The safe sedation of children for procedures requires a systematic approach that includes the following: no administration of sedating medication without the safety net of medical supervision, careful presedation evaluation for underlying medical or surgical conditions that would place the child at increased risk from sedating medications, appropriate fasting for elective procedures and a balance between depth of sedation and risk for those who are unable to fast because of the urgent nature of the procedure, a focused airway examination for large tonsils or anatomic airway abnormalities that might increase the potential for airway obstruction, a clear understanding of the pharmacokinetic and pharmacodynamic effects of the medications used for sedation as well as an appreciation for drug interactions, appropriate training and skills in airway management to allow rescue of the patient, age- and size-appropriate equipment for airway management and venous access, appropriate medications and reversal agents, sufficient numbers of people to both carry out the procedure and monitor the patient, appropriate physiologic monitoring during and after the procedure, a properly equipped and staffed recovery area, recovery to presedation level of consciousness before discharge from medical supervision, and appropriate discharge instructions.