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Biomedical subjects

Martha A Q Curley

Publications and source records attributed to Martha A Q Curley.

17 recordsLinked to original sources

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↗

Smaller mandibular size in infants with a history of an apparent life-threatening event.

OBJECTIVES: To examine small mandibular size and preference for a hand-to-chin posture as salient characteristics in infants with a history of an apparent life-threatening event (ALTE). STUDY DESIGN: This was a prospective case-control study of term infants, from birth to 6 months of age, admitted post-ALTE and matched 1:2 with healthy control infants (age within 2 weeks and weight within 0.5 kg). Infants with confirmed gastroesophageal reflux and congenital anomalies, including severe micrognathia, were excluded. RESULTS: Infants with a history of an ALTE (n = 25) were matched to 47 healthy controls. Infants with a history of an ALTE had mandibular indices (larger index indicates a smaller mandible) that were 3.8 mm greater on the left side (95% CI: 2.0-5.6, P < .001) and 4.2 mm greater on the right side (95% CI: 2.7-5.6, P < .001) adjusting for length and non-white race. Controlling for matching and length, a 1-mm increase in the average mandibular index increased the odds of an ALTE by 62% (OR = 1.62, 95% CI: 1.22-2.44, P < .001). CONCLUSIONS: Smaller mandibular size was associated with ALTE, suggesting airway obstruction as a potential cause of ALTE. The association of this characteristic with ALTE also offers the potential for prospective quantification of ALTE risk.

Adolescent↗

Tailoring the Institute for Health Care Improvement 100,000 Lives Campaign to pediatric settings: the example of ventilator-associated pneumonia.

In December 2004, the Institute for Healthcare Improvement launched a campaign to save 100,000 lives by implementing evidence-based interventions in six areas, five of which are relevant to children. Working collaboratively, the Child Health Corporation of America, National Associate of Children's Hospitals and Related Institutions, and National Initiative for Children's Health Care Quality provided a series of Web-enabled seminars on how the campaign initiatives might be adapted for pediatric settings. Ventilator-associated pneumonia (VAP) is an example of how interventions based on evidence in adult settings may need to be tailored in pediatric settings. The authors describe how assessing and implementing parts of the VAP bundle led to reduction in VAP in two children's hospitals.

Adolescent↗

Skin integrity in hospitalized infants and children: a prevalence survey.

The purpose of this paper was to describe the spectrum of alterations in skin integrity and skin care needs of hospitalized infants and children. A 1-day skin prevalence audit was conducted in the spring of 2005 in a tertiary care university-affiliated children's hospital. Patient skin was assessed for any alterations. The Braden Q Scale was used to assess patient risk for pressure ulcer development. Alterations in skin integrity included diaper dermatitis, pressure ulcers, intravenous infiltrations, device-related injuries, and epidermal injuries. Many patients required additional skin care, including wound/incision care, ostomy care, and care related to invasive devices. Alterations in skin integrity represent a serious problem in the pediatric inpatient setting. The data presented identify skin integrity challenges in the hospitalized patient and can help guide staff education and resource allocation, encourage evidenced-based management protocols, and serve as a benchmark for similar pediatric facilities.

Benchmarking↗

The Nightingale Metrics.

Staff nurses at Children's Hospital Boston worked together to identify what was important to the patients and families they cared for, measured how often nurses performed these interventions, and used the data to improve the care they provide. This initiative, the Nightingale Metric Project, can serve as a model for ongoing measurement and improvement of nursing care in all settings.

Attitude of Health Personnel↗

State Behavioral Scale: a sedation assessment instrument for infants and young children supported on mechanical ventilation.

OBJECTIVE: To develop and test the reliability and validity of the State Behavioral Scale for use in describing sedation/agitation levels in young intubated patients supported on mechanical ventilation. DESIGN: : In this prospective, psychometric evaluation, pairs of trained pediatric critical care nurse evaluators simultaneously and independently assessed a convenience sample of pediatric intensive care unit patients along eight state/behavioral dimensions and a numeric rating scale (NRS) of 0 (extremely sedated) to 10 (extremely agitated). The eight dimensions were derived from the sedation/agitation literature and expert opinion and included respiratory drive, response to ventilation, coughing, best response to stimulation, attentiveness to careprovider, tolerance to care, consolability, and movement after consoled, each with 3-5 levels. SETTING: An 18-bed pediatric medical-surgical intensive care unit and 26-bed pediatric cardiovascular intensive care unit in a university-affiliated academic children's hospital. PATIENTS: A total of 91 intubated mechanically ventilated patients 6 wks to 6 yrs of age provided a median of two observations (interquartile range, 1-3) for a total of 198 sets of observations. Excluded were postoperative patients or those receiving neuromuscular blockade. INTERVENTIONS: Patients were observed for 1 min, and then incremental levels of stimulation were applied until patient response. After 2 mins of consoling, the state behavioral assessment and NRS were completed. MEASUREMENTS: Weighted kappa and intraclass coefficients were generated to assess interrater reliability of the eight dimension and NRS ratings. Distinct state behavior profiles were empirically identified from the dimension ratings using hierarchical cluster analysis using a squared Euclidean distance measure and between-groups linkage. Construct validity of these profiles was assessed by comparing group mean NRS scores using one-way analysis of variance. MAIN RESULTS: Weighted kappa scores for all 198 dimension ratings ranged from .44 to .76, indicating moderate to good interrater reliability. The intraclass coefficient of .79 was high for NRS ratings. Cluster analysis revealed five distinct state profiles, with mean NRS ratings of 1.1, 2.5, 4.0, 5.3, and 7.6, all of which differed significantly from each other (F = 75.8, p < .001), supporting the profiles' construct validity. CONCLUSIONS: Based on empirically derived state behavior profiles, we have constructed the State Behavioral Scale to allow systematic description of the sedation-agitation continuum in young pediatric patients supported on mechanical ventilation. Further studies including prospective validation and describing the effect of State Behavioral Scale implementation on clinical outcomes, including the quality of sedation and length of mechanical ventilation, are warranted.

Child↗

Prone positioning can be safely performed in critically ill infants and children.

OBJECTIVE: To describe the effects of prone positioning on airway management, mechanical ventilation, enteral nutrition, pain and sedation management, and staff utilization in infants and children with acute lung injury. DESIGN: Secondary analysis of data collected in a multiple-center, randomized, controlled clinical trial of supine vs. prone positioning. SETTING: Seven pediatric intensive care units located in the United States. PATIENTS: One hundred and two pediatric patients (51 prone and 51 supine) with acute lung injury. INTERVENTIONS: Patients randomized to the supine group remained supine. Patients randomized to the prone group were positioned prone per protocol during the acute phase of their illness for a maximum of 7 days. Both groups were managed using ventilator and sedation protocols and nutrition and skin care guidelines. MEASUREMENTS AND MAIN RESULTS: Airway management and mechanical ventilatory variables before and after repositioning, enteral nutrition management, pain and sedation management, staff utilization, and adverse event data were collected for up to 28 days after enrollment. There were a total of 202 supine-prone-supine cycles. There were no differences in the incidence of endotracheal tube leak between the two groups (p = .30). Per protocol, 95% of patients remained connected to the ventilator during repositioning. The inadvertent extubation rate was 0.85 for the prone group and 1.03 for the supine group per 100 ventilator days (p = 1.00). There were no significant differences in the initiation of trophic (p = .24), advancing (p = .82), or full enteral feeds (p = .80) between the prone and supine groups; in the average pain (p = .81) and sedation (p = .18) scores during the acute phase; and in the amount of comfort medications received between the two groups (p = .91). There were no critical events during a turn procedure. While prone, two patients experienced an obstructed endotracheal tube. One patient, supported on high-frequency oscillatory ventilation, experienced persistent hypercapnea when prone and was withdrawn from the study. The occurrence of pressure ulcers was similar between the two groups (p = .71). Compared with the supine group, more staff (p </= .001) and more time were necessary to reposition patients in the prone group. CONCLUSIONS: Our data show that prone positioning can be safely performed in critically ill pediatric patients and that these patients can be safely managed while in the prone position for prolonged periods of time.

Analgesia↗

Effect of prone positioning on clinical outcomes in children with acute lung injury: a randomized controlled trial.

CONTEXT: In uncontrolled clinical studies, prone positioning appeared to be safe and to improve oxygenation in pediatric patients with acute lung injury. However, the effect of prone positioning on clinical outcomes in children is not known. OBJECTIVE: To test the hypothesis that at the end of 28 days infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning. DESIGN, SETTING, AND PATIENTS: Multicenter, randomized, controlled clinical trial conducted from August 28, 2001, to April 23, 2004, of 102 pediatric patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who were treated with supine vs prone positioning. Randomization was concealed and group assignment was not blinded. INTERVENTION: Patients were randomized to either supine or prone positioning within 48 hours of meeting acute lung injury criteria, with those patients in the prone group being positioned within 4 hours of randomization and remaining prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days, after which they were positioned supine. Both groups were treated using lung protective ventilator and sedation protocols, extubation readiness testing, and hemodynamic, nutrition, and skin care guidelines. MAIN OUTCOME MEASURE: Ventilator-free days to day 28. RESULTS: The trial was stopped at the planned interim analysis on the basis of the prespecified futility stopping rule. There were no differences in the number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5] supine vs 15.6 [8.6] prone; mean difference, -0.2 days; 95% CI, -3.6 to 3.2; P = .91). After controlling for age, Pediatric Risk of Mortality III score, direct vs indirect acute lung injury, and mode of mechanical ventilation at enrollment, the adjusted difference in ventilator-free days was 0.3 days (95% CI, -3.0 to 3.5; P = .87). There were no differences in the secondary end points, including proportion alive and ventilator-free on day 28 (P = .45), mortality from all causes (P>.99), the time to recovery of lung injury (P = .78), organ-failure-free days (P = .88), and cognitive impairment (P = .16) or overall functional health (P = .12) at hospital discharge or on day 28. CONCLUSION: Prone positioning does not significantly reduce ventilator-free days or improve other clinical outcomes in pediatric patients with acute lung injury.

Adolescent↗

Alternative outcome measures for pediatric clinical sepsis trials.

OBJECTIVE: To review nonmortality outcome measures in clinical trials of therapies to treat sepsis in children. DATA SOURCE: Literature review using the search word terms "sepsis" + "surrogate markers," "sepsis" + "biomarkers," or "sepsis" + "outcomes." STUDY SELECTION: Articles were generally categorized as those dealing with review of patient-centered outcomes, characteristics of good surrogate markers, resolution of organ dysfunction, morbidity and functional status, quality-of-life measures, intensive care unit costs, and biomarkers. DATA EXTRACTION AND SYNTHESIS: Information potentially relevant for development of surrogate markers for pediatric sepsis trials was extracted and organized as noted above. CONCLUSIONS: Multiple potential surrogate markers are being actively investigated for their potential validity and utility in pediatric clinical trials of sepsis and increasingly for adult sepsis trials. This is important because as mortality decreases, it becomes an impractical primary end point. Surrogate end points that address patient-related morbidity and intensive care unit costs may also be quantified. Treatment of sepsis and corresponding end points for clinical trials should be aimed at both the duration and the quality of survival.

Child↗

Pain assessment in nonverbal children with severe cognitive impairments: the Individualized Numeric Rating Scale (INRS).

Children's Hospital Boston began a major pain assessment and management initiative 3 years ago: Pain assessment and management are considered one of the institution's primary standards of care. The initiative included State of the Science meetings with internationally renowned nursing pain researchers and clinicians. These meetings generated nursing staff interest in specific applications of what is known about pain; how evidence-based knowledge can be used to ask population-specific clinical questions; and how an evidence-based approach can be applied to systematically develop, implement, and assess interventions that suit a population's clinical needs. This article is an example of an evidence-based pain assessment project at Children's Hospital Boston that focused on nonverbal children with cognitive impairments. After developing a clinical question, the authors did a literature review and a benchmarking analysis of best practice. The pilot of an adapted, existing pain assessment tool is described in this article.

Child↗

Parental experience of highly technical therapy: survivors and nonsurvivors of extracorporeal membrane oxygenation support.

OBJECTIVE: To describe the experience of parents of critically ill infants and children who require highly technical therapy and to identify interventions that parents might find helpful during the experience. DESIGN: Nonexperimental 8-yr descriptive study. SETTING: Pediatric intensive care unit within a children's hospital. PATIENTS: Parents of infants and children who were supported on extracorporeal membrane oxygenation (ECMO). INTERVENTIONS: Questionnaires, mailed 4-months after ECMO support, inquired about parent preparation and emotional responses, concerns, family-staff communication related to ECMO, and whether, retrospectively, parents would have consented again to ECMO. MEASUREMENTS AND MAIN RESULTS: Two hundred seventy-two parents responded. More than 25% of parents reported being reassured by the hope of therapy. Sixty percent reported they felt they really did not have a choice but to consent to ECMO, given the severity of their child's condition. Upon first seeing their child on ECMO support, most parents reported feeling relieved to see their child alive and being as well prepared as possible. Although some parents remained anxious throughout the ECMO course, talking with care providers and observing the child's daily progress lessened parental fears. Although parents in the nonsurvivor group recalled discussing death before ECMO, 22% remembered first hearing about the possibility of death only after their child failed to improve while undergoing ECMO. During the process of ECMO withdrawal, nearly one fourth of the nonsurvivor group expected their child to fool everyone and to live. After their child's death, 93% felt comforted by follow-up contact with hospital personnel. Compared with the survivor group, fewer parents of nonsurvivors reported that they would again consent to ECMO. CONCLUSIONS: Researched-based family-driven care requires an understanding of parental experience and worries, and interventions that parents themselves identify as helpful. Continued sensitive individualized care is warranted.

Adaptation, Psychological↗

Pressure ulcers in pediatric intensive care: incidence and associated factors.

OBJECTIVE: To describe the incidence, location, and factors associated with the development of pressure ulcers in patients cared for in the pediatric intensive care unit (PICU). DESIGN: Multisite prospective cohort study. SETTING: Three PICUs contained within freestanding children's hospitals. PATIENTS: A total of 322 patients, 21 days to 8 yrs of age, on bed rest in the PICU for at least 24 hrs without preexisting pressure ulcers or congenital heart disease. INTERVENTION: Patients were observed up to three times a week for 2 wks, then once a week until PICU discharge for a median of two observation periods (interquartile range, 1-4), reflecting 877 skin assessments. Skin assessments were independently rated, and data collectors were blinded to the assessments of the others. MEASUREMENTS AND MAIN RESULTS: Pressure ulcers were staged according to the American National Pressure Ulcer Advisory Panel Consensus Development Conference recommendations. Eighty-six patients (27%) developed 199 pressure ulcers; 139 (70%) were Stage I, 54 (27%) were Stage II, and 6 (3%) were Stage III. Of the 60 Stage II/III pressure ulcers, 19 (32%) involved the head. Stage III pressure ulcers involved the occiput, ear, chest, and coccyx. An additional 27 pressure-related injuries were caused by medical devices. Statistically significant Stage I pressure ulcer predictor variables include the use of mechanical ventilation, mean arterial pressures < or =50 mm Hg, and lower Braden Q scores. CONCLUSIONS: PICU patients at risk include those supported on mechanical ventilation, those with hypotension, and those who have low Braden Q scores. This study provides unique benchmark data for the general PICU population from which pediatric interventional studies can be designed to reduce the incidence of pressure ulcers in this vulnerable patient population.

Age Factors↗

Predicting pressure ulcer risk in pediatric patients: the Braden Q Scale.

BACKGROUND: While there are valid and reliable pressure ulcer risk assessment tools available for adult patients, none exist for infants and children. To remedy this, the Braden Scale was adapted for use in pediatrics, calling it the Braden Q Scale. OBJECTIVE: The purpose of this study was to: (a) establish the predictive validity of the Braden Q Scale in an acutely ill pediatric population; (b) determine the critical cutoff point for classifying patient risk; and (c) determine the best time to assess patient risk. METHODS: A multisite prospective cohort descriptive study with a convenience sample of 322 patients on bedrest for at least 24 hours without pre-existing pressure ulcers or congenital heart disease were enrolled from three pediatric intensive care units (PICU). The Braden Q score and skin assessment were independently rated and data collectors were blind to the other measures. Patients were observed up to 3 times per week for 2 weeks and then once a week until PICU discharge for a median of 2 observations reflecting 887 skin assessments. RESULTS: Eighty-six patients (27%) developed 199 pressure ulcers; 139 (70%) were Stage I pressure ulcers, 54 (27%) were Stage II pressure ulcers, and 6 (3%) were Stage III pressure ulcers. Most pressure ulcers (57%) were present at the first observation. Using Stage II+ pressure ulcer data obtained during the first observation, a Receiver Operator Characteristic (ROC) curve for each possible score of the Braden Q Scale was constructed. The area under the curve (AUC) was 0.83. At a cutoff score of 16, the sensitivity was 0.88 and the specificity was 0.58. The Braden Q Scale was then modified to eliminate 4 subscales with an AUC <0.7. With 3 subscales (mobility, sensory perception, tissue perfusion/oxygenation) the AUC of this Modified Braden Q Scale was maintained at 0.84. At a cutoff score of 7, the sensitivity was 0.92 and the specificity was 0.59. CONCLUSIONS: The performance of the Braden Q Scale in a pediatric population is similar to that consistently reported for the Braden Scale in adult patients. The Modified Braden Q Scale, with 3 subscales, provides a shorter yet comparable tool.

Acute Disease↗