Mary Jo C. Grant

Protocolized Sedation vs Usual Care in Pediatric Patients Mechanically Ventilated for Acute Respiratory Failure: A Randomized Clinical Trial

IMPORTANCE Protocolized sedation improves clinical outcomes in critically ill adults, but its effect in children is unknown. OBJECTIVE To determine whether critically ill children managed with a nurse-implemented, goal-directed sedation protocol experience fewer days of mechanical ventilation than patients receiving usual care. DESIGN, SETTING, AND PARTICIPANTS Cluster randomized trial conducted in 31 US pediatric intensive care units (PICUs). A total of 2449 children (mean age, 4.7 years; range, 2 weeks to 17 years) mechanically ventilated for acute respiratory failure were enrolled in 2009-2013 and followed up until 72 hours after opioids were discontinued, 28 days, or hospital discharge. INTERVENTION Intervention PICUs (17 sites; n = 1225 patients) used a protocol that included targeted sedation, arousal assessments, extubation readiness testing, sedation adjustment every 8 hours, and sedation weaning. Control PICUs (14 sites; n = 1224 patients) managed sedation per usual care. MAIN OUTCOMES AND MEASURES The primary outcome was duration of mechanical ventilation. Secondary outcomes included time to recovery from acute respiratory failure, duration of weaning from mechanical ventilation, neurological testing, PICU and hospital lengths of stay, in-hospital mortality, sedation-related adverse events, measures of sedative exposure (wakefulness, pain, and agitation), and occurrence of iatrogenic withdrawal. RESULTS Duration of mechanical ventilation was not different between the 2 groups (intervention: median, 6.5 [IQR, 4.1-11.2] days; control: median, 6.5 [IQR, 3.7-12.1] days). Sedation-related adverse events including inadequate pain and sedation management, clinically significant iatrogenic withdrawal, and unplanned endotracheal tube/invasive line removal were not significantly different between the 2 groups. Intervention patients experienced more postextubation stridor (7% vs 4%; P = .03) and fewer stage 2 or worse immobility-related pressure ulcers (<1% vs 2%; P = .001). In exploratory analyses, intervention patients had fewer days of opioid administration (median, 9 [IQR, 5-15] days vs 10 [IQR, 4-21] days; P = .01), were exposed to fewer sedative classes (median, 2 [IQR, 2-3] classes vs 3 [IQR, 2-4] classes; P < .001), and were more often awake and calm while intubated (median, 86% [IQR, 67%-100%] of days vs 75% [IQR, 50%-100%] of days; P = .004) than control patients, respectively; however, intervention patients had more days with any report of a pain score ≥ 4 (median, 50% [IQR, 27%-67%] of days vs 23% [IQR, 0%-46%] of days; P < .001) and any report of agitation (median, 60% [IQR, 33%-80%] vs 40% [IQR, 13%-67%]; P = .003), respectively. CONCLUSIONS AND RELEVANCE Among children undergoing mechanical ventilation for acute respiratory failure, the use of a sedation protocol compared with usual care did not reduce the duration of mechanical ventilation. Exploratory analyses of secondary outcomes suggest a complex relationship among wakefulness, pain, and agitation. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00814099.

Preventable harm occurring to critically ill children.

Objective: To develop a trigger tool for identifying adverse events occurring in critically ill pediatric patients; to identify and characterize adverse events and preventable adverse events experienced by critically ill pediatric patients; and to characterize the patients who experience preventable adverse events. Design: Retrospective chart review using a trigger tool. Setting: Pediatric intensive care unit of a tertiary, university-affiliated pediatric hospital. Patients: A systematic sample of 259 pediatric intensive care unit patients from a 1-yr period. Interventions: None. Measurements and Main Results: We measured frequency of occurrence (0.19 preventable adverse events per patient-day), severity of harm (78% minor, 19% moderate, 3% serious, no deaths), and type of event (sedation, 22%; skin, 16%; medical device complication, 14%; pulmonary, 13%; and cardiovascular, 11%). Patients who experienced preventable adverse events were younger, had longer lengths of stay, and had higher illness burdens. Preventable adverse events occurred more frequently among surgical patients than medical patients. Conclusions: Preventable adverse events occurred fairly frequently in the pediatric intensive care unit, but serious harm was rare. Conditions that increased the likelihood of a preventable adverse event were a) need for sedation or pain control; b) relative immobility; and c) need for vascular devices, feeding tubes, or ventilators. Adverse event prevention strategies that focus on improving patient monitoring under increased-risk conditions and improving early detection and treatment of potential harm will likely be more effective than strategies aimed at general error prevention.

Financial impact of elimination of routine chest radiographs in a pediatric intensive care unit.

OBJECTIVE To determine the change in chest radiograph use if each chest radiograph requires a separate order and clinical indication. DESIGN Prospective, nonrandomized, controlled design with an intervention. SETTING The pediatric intensive care unit (PICU) at Primary Childrens Medical Center, Salt Lake City, UT. PATIENTS The study comprised 3,727 PICU patients treated between 1992 and 1996. INTERVENTIONS A change in ordering practice: There will be no standing orders for routine daily morning chest radiographs. Each radiograph requires a written order and a clinical indication. MEASUREMENTS AND MAIN RESULTS During a 29-month control phase when routine daily chest radiographs were obtained for all intubated patients, 1.026 chest radiographs per patient day were performed. After the intervention, the ratio dropped to 0.653 chest radiographs per patient day, a decrease of 36.4%. This resulted in a (projected) variable cost savings of

Nonradiographic assessment of enteral feeding tube position

45,476. Data were also collected for quality assurance purposes. CONCLUSIONS These results demonstrate the impact of an evaluation and subsequent change in radiology ordering practice in our PICU. The change resulted in decreased variability in ordering practice, fewer chest radiographs per patient, and an accompanying cost savings to our patients and payors.

The safety culture in a children's hospital.

OBJECTIVE To determine whether a clinical, nonradiographic criterion can be used to predict when the tip of a blindly placed feeding tube is in the small intestine. DESIGN Prospective sample. SETTING Pediatric intensive care unit at a tertiary care childrens hospital. PATIENTS Critically ill children requiring transpyloric feeding. INTERVENTIONS The small bowel was intubated, using a blind, bedside transpyloric feeding tube placement protocol. The feeding tube was considered to be in the small bowel when <2 mL of a 10- mL aliquot of insufflated air could be aspirated from the feeding tube. This clinical criterion was confirmed with an abdominal radiograph. MEASUREMENTS AND MAIN RESULTS Patient age ranged from 1 month to 19 yrs (median 6 months). Weight ranged from 2.2 to 60 kg (median 4.9). Median time to feeding tube placement was 10 mins (range 5 to 60). Eighty-nine percent of the patients were mechanically ventilated, while 28% of these patients were pharmacologically paralyzed. Seventy-five feeding tubes were inserted. There were no known complications. Ninety-nine (74/75) percent of the feeding tubes were positioned in the small bowel. The inability to aspirate insufflated air correctly predicted small bowel intubation with 99% certainty (Sequential Probability Ratio Test, p = .05 and power = .80). This test incorrectly predicted the position of only one feeding tube, the 26th, which was in the stomach. Of the 74 feeding tubes positioned in the small bowel, 13 feeding tubes were in the duodenum and 61 were in the jejunum. CONCLUSIONS The inability to aspirate insufflated air confirms the transpyloric position of a feeding tube. Other clinical criteria did not successfully predict small bowel intubation. Use of this single test may obviate confirmatory abdominal radiographs in carefully selected patients and may lead to more cost-effective and timely initiation of enteral feedings.

Effect of an anonymous reporting system on near-miss and harmful medical error reporting in a pediatric intensive care unit.

Efforts to improve patient safety require an understanding of organizational culture. In a survey of inpatient healthcare providers in a childrens hospital, physician perceptions of teamwork were higher than those of all other staff (P < .001). Recognition of the impact of stress and fatigue was low, and job satisfaction was high for all groups. A majority of respondents did not feel rewarded for incident reporting. Information on hospital-level safety culture can lead to targeted system improvement.

Prospective evaluation of sedation-related adverse events in pediatric patients ventilated for acute respiratory failure

Adverse event reporting is a key element for improving patient safety. This study describes a new voluntary, anonymous reporting system that facilitates reporting of near-miss and patient harm events and an assessment of patient harm by the bedside care provider in a pediatric intensive care unit. The results demonstrated the effectiveness of the Patient Safety Report as a method to capture near-miss and patient harm events.

A cost analysis of enterally administered lorazepam in the pediatric intensive care unit.

Objectives:Sedation-related adverse events in critically ill pediatric patients lack reproducible operational definitions and reference standards. Understanding these adverse events is essential to improving the quality of patient care and for developing prevention strategies in critically ill children. The purpose of this study was to test operational definitions and estimate the rate and site-to-site heterogeneity of sedation-related adverse events. Design:Prospective cohort study. Setting:Twenty-two pediatric intensive care units in the United States enrolling baseline patients into a prerandomization phase of a multicenter trial on sedation management. Patients:Pediatric patients intubated and mechanically ventilated for acute respiratory failure. Data Extraction:Analysis of adverse event data using consistent operational definitions from a Web-based data management system. Measurements and Main Results:There were 594 sedation-related adverse events reported in 308 subjects, for a rate of 1.9 adverse events per subject and 16.6 adverse events per 100 pediatric intensive care unit days. Fifty-four percent of subjects had at least one adverse event. Seven (1%) adverse events were classified as severe, 347 (58%) as moderate, and 240 (40%) as mild. Agitation (30% of subjects, 41% of events) and pain (27% of subjects, 29% of events) were the most frequently reported events. Eight percent of subjects (n = 24) experienced 54 episodes of clinically significant iatrogenic withdrawal. Unplanned endotracheal tube extubation occurred at a rate of 0.82 per 100 ventilator days, and 32 subjects experienced postextubation stridor. Adverse events with moderate intraclass correlation coefficients included: Inadequate sedation management (intraclass correlation coefficient = 0.130), clinically significant iatrogenic withdrawal (intraclass correlation coefficient = 0.088), inadequate pain management (intraclass correlation coefficient = 0.080), and postextubation stridor (intraclass correlation coefficient = 0.078). Conclusions:Operational definitions for sedation-related adverse events were consistently applied across multiple pediatric intensive care units. Adverse event rates were different from what has been previously reported in single-center studies. Many adverse events have moderate intraclass correlation coefficients, signaling site-to-site heterogeneity. (Crit Care Med 2012; 40:–1323)

Effect of red blood cell transfusion on oxygen consumption in the anemic pediatric patient.

OBJECTIVE To determine the cost savings of replacing intravenous midazolam with enterally administered lorazepam in mechanically ventilated children who require long-term continuous sedation. DESIGN Retrospective review of patients treated according to a preestablished pediatric intensive care unit (ICU) sedation protocol. SETTING Twenty-six-bed pediatric ICU in a tertiary care childrens hospital. PATIENTS The records of 30 mechanically ventilated children were analyzed. The median age was 1.5 yrs and the median weight was 8.0 kg. Patients required continuous sedation for a total of 16 days (median). INTERVENTIONS According to our pediatric ICU sedation protocol, midazolam infusion was continued until the hourly midazolam requirement was stable for at least 24 hrs. Thereafter, patients with a nasojejunal tube who were likely to require a minimum of three additional days of continuous sedation were transitioned from intravenous midazolam to enterally administered lorazepam. The goal in transitioning therapy was to titrate the lorazepam dose and reduce midazolam administration while maintaining an unchanged level of sedation. MEASUREMENTS AND MAIN RESULTS The rate of midazolam administration was significantly (p<.05) reduced beginning on day 1 of lorazepam treatment. Midazolam was successfully discontinued in 24 (80%) patients in 3 days (median), and adequate and appropriate sedation was maintained with lorazepam monotherapy. Six patients in whom midazolam could not be discontinued experienced a 52% reduction in the rate of midazolam administration as a result of adding lorazepam. Total projected midazolam utilization was defined as the sum of midazolam administration before initiating lorazepam and the projected midazolam requirement after initiating lorazepam. Projected midazolam cost was calculated as the product of total projected midazolam utilization and midazolam acquisition cost. Actual expenditures for both midazolam and lorazepam were subtracted from the projected midazolam cost to calculate the estimated cost savings. Overall, midazolam utilization (in milligrams) was reduced by 46.7+/-27.6% (median 52). Total projected midazolam cost for the 30 patients was

Defining sedation-related adverse events in the pediatric intensive care unit

90,771. The actual cost of midazolam and lorazepam combined was