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Biomedical subjects

James C Fackler

Publications and source records attributed to James C Fackler.

7 recordsLinked to original sources
PubMed2006

Clinical trial design--effect of prone positioning on clinical outcomes in infants and children with acute respiratory distress syndrome.

PURPOSE: This paper describes the methodology of a clinical trial of prone positioning in pediatric patients with acute lung injury (ALI). Nonrandomized studies suggest that prone positioning improves oxygenation in patients with ALI/acute respiratory distress syndrome without the risk of serious iatrogenic injury. It is not known if these improvements in oxygenation result in improvements in clinical outcomes. A clinical trial was needed to answer this question. MATERIALS AND METHODS: The pediatric prone study is a multicenter, randomized, noncrossover, controlled clinical trial. The trial is designed to test the hypothesis that at the end of 28 days, children with ALI treated with prone positioning will have more ventilator-free days than children treated with supine positioning. Secondary end points include the time to recovery of lung injury, organ failure-free days, functional outcome, adverse events, and mortality from all causes. Pediatric patients, 42 weeks postconceptual age to 18 years of age, are enrolled within 48 hours of meeting ALI criteria. Patients randomized to the prone group are positioned prone within 4 hours of randomization and remain prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days. Both groups are managed according to ventilator protocol, extubation readiness testing, and sedation protocols and hemodynamic, nutrition, and skin care guidelines. CONCLUSIONS: This paper describes the process, multidisciplinary input, and procedures used to support the design of the clinical trial, as well as the challenges faced by the clinical scientists during the conduct of the clinical trial.

Adolescent↗
PubMed2005

Preventing adverse events in the pediatric intensive care unit: prospectively targeting factors that lead to intravenous potassium chloride order errors.

OBJECTIVE: To prospectively identify and reduce proximal causes of error contributing to inappropriate intravenous potassium chloride orders and reduce adverse events subsequent to these ordering errors. DESIGN: Pre-post cohort study of the reduction in both proximal causes of error and number of postinfusion elevated serum potassium levels after intervention. SETTING: Sixteen-bed, tertiary care, urban, academic pediatric intensive care unit. PATIENTS: Children 0-18 yrs old receiving intravenous potassium chloride in the pediatric intensive care unit. INTERVENTIONS: A multidisciplinary team determined proximal causes of error that were likely contributors to the occurrence of the outcome measure, elevated potassium levels after intravenous potassium chloride. A mandatory drug request form was designed for physicians ordering intravenous potassium chloride. The drug request form was designed to reduce proximal causes of error and, as a result, elevated potassium levels after intravenous potassium chloride. Demographic and laboratory data on children receiving intravenous potassium chloride in the pediatric intensive care unit and details of the drug order were analyzed. MEASUREMENTS AND MAIN RESULTS: Data from 1,492 intravenous potassium chloride administration-events before implementation of the drug request form were collected. After the drug request form was mandated, 166 consecutively completed forms were collected and analyzed. The incidence of postinfusion elevations in serum potassium decreased from a rate of 7.7% (103 of 1,341) before the drug request form to 0% (0 of 150) after the drug request form (p < .001). Proximal causes of error were also reduced. The number of patients with a creatinine >/=2 mg/dL receiving intravenous potassium chloride decreased from 28.4% to 14.2% (p < .001). The number of intravenous potassium chloride infusions administered to patients where serum potassium value was >4.5 mmol/L decreased significantly (2.9% vs. 0.0%, p < .02). The incidence rates of both verbal orders and failure to write the order in a correct format were reduced to zero. CONCLUSIONS: Simple, blame-free, system-wide interventions designed to reduce proximal causes of error can be an effective, proactive means of reducing the likelihood of medical morbidity.

Adolescent↗
PubMed2004

Gender and age effects on outcome after pediatric traumatic brain injury.

OBJECTIVE: To evaluate whether girls have better outcomes after traumatic brain injury than boys. DESIGN: Retrospective cohort study. SETTING: University hospital. PATIENTS: A 16,586 patient subset of the National Pediatric Trauma Registry with nonpenetrating traumatic brain injury. INTERVENTIONS: Retrospective review. MEASUREMENTS AND MAIN RESULTS: The patients were subdivided by age into prepubertal (0-7 yrs), indeterminate pubertal (8-12 yrs), and probable pubertal (13-19 yrs). All analyses were adjusted for injury severity using the Injury Severity Score. Outcome variables were in-hospital death rate, intensive care unit length of stay, total length of stay, discharge to home vs. rehabilitation, and functional status at discharge. Overall, 6.1% of girls and 5.3% of boys died. A higher proportion of girls were injured in motor vehicle crashes. Gender did not have a significant effect on in-hospital mortality rate after adjustment for age, Injury Severity Score, and motor vehicle crashes. Boys had a shorter intensive care unit length of stay (p =.027). There were no statistically significant differences between boys and girls in total hospital length of stay, functional outcome, and discharge location, although for every outcome there was a trend toward girls doing worse. CONCLUSIONS: There is evidence from this large study that girls do not have a better outcome after pediatric traumatic brain injury than boys, with a suggestion that girls may do worse.

Adolescent↗
PubMed2003

Noise, stress, and annoyance in a pediatric intensive care unit.

OBJECTIVE: To measure and describe hospital noise and determine whether noise can be correlated with nursing stress measured by questionnaire, salivary amylase, and heart rate. DESIGN: Cohort observational study. SETTING: Tertiary care center pediatric intensive care unit. SUBJECTS: Registered nurses working in the unit. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Eleven nurse volunteers were recruited. An audiogram, questionnaire data, salivary amylase, and heart rate were collected in a quiet room. Each nurse was observed for a 3-hr period during patient care. Heart rate and sound level were recorded continuously; saliva samples and stress/annoyance ratings were collected every 30 mins. Variables assessed as potential confounders were years of nursing experience, caffeine intake, patients' Pediatric Risk of Mortality Score, shift assignment, and room assignment. Data were analyzed by random effects multiple linear regression using Stata 6.0. The average daytime sound level was 61 dB(A), nighttime 59 dB(A). Higher average sound levels significantly predicted higher heart rates (p =.014). Other significant predictors of tachycardia were higher caffeine intake, less nursing experience, and daytime shift. Ninety percent of the variability in heart rate was explained by the regression equation. Amylase measurements showed a large variability and were not significantly affected by noise levels. Higher average sound levels were also predictive of greater subjective stress (p =.021) and annoyance (p =.016). CONCLUSIONS: In this small study, noise was shown to correlate with several measures of stress including tachycardia and annoyance ratings. Further studies of interventions to reduce noise are essential.

Amylases↗