Alarm safety and oxygen saturation targets in the Vermont Oxford Network iNICQ 2015 collaborative.

OBJECTIVES: To assess progress of neonatal intensive care units (NICUs) participating in the Vermont Oxford Network iNICQ 2015: Alarm Safety Collaborative in achieving Joint Commission 2014 alarm safety goals with respect to oximeters, and to compare patient-level oxygen saturation (SpO2) and oximeter alarm data to local policies. STUDY DESIGN: Prospective multicenter audits in February and August 2015 assessed implementation of policies addressing Joint Commission 2014 Alarm Safety goals, and ascertained SpO2 targets, oximeter alarm settings and compliance with policy-specified SpO2 targets and alarms. RESULTS: Eighty-six NICUs completed both audits. Of 13 policies addressing mandated goals, median (interquartile range) 8 (5, 9) policies were implemented at audit 1 and 9 (6, 11) at audit 2 (P=0.004). At audit 1, 28 NICUs had implemented ⩾9 policies versus 47 at audit 2. For 794 infants <31 weeks gestation, <36 weeks postmenstrual age, and on supplemental oxygen, median SpO2 target lower limit was 88% (interquartile range 87%, 90%; range 75% to 94%), upper limit 95% (interquartile range 94%, 96%; range 85% to 100%). High oximeter alarm was set according to local policy for 63% of infants, for whom SpO2 >97% was less frequent than when high alarm was not set to policy (10.1% vs 21.5%, P=0.006). CONCLUSIONS: Participating NICUs showed significant progress between audits in their implementation of Joint Commission Alarm Safety goals for oximeter monitoring. Oximeter high alarm not set per local policy is associated with increased hyperoxemia in preterm infants. Recommendations to standardize oxygen saturation targets for infants at risk for oxygenation-related outcomes have not been widely adopted.

Decreasing mortality associated with the introduction of surfactant therapy: an observational study of neonates weighing 601 to 1300 grams at birth. The Members of the National Institute of Child Health and Human Development Neonatal Research Network.

OBJECTIVE: To determine whether the introduction of surfactant therapy was associated with decreased mortality for high-risk preterm neonates weighing 601 to 1300 g at birth. DESIGN: Before-after observational study. SETTING: Eight tertiary care neonatal intensive care units participating in the National Institute of Child Health and Human Development Neonatal Research Network. PATIENTS: The outcomes for neonates with birth weight 601 to 1300 g admitted in the 2 years before surfactants became available (n = 2780) were compared with those of neonates admitted in the year beginning 2 months after surfactants became available (n = 1413). MAIN OUTCOME MEASURES: The primary outcome measure was in-hospital mortality; secondary outcome measures included durations of assisted ventilation, length of hospitalization, and neonatal morbidity. RESULTS: Forty percent of neonates in the postsurfactant group received surfactant (range 28% to 69% at the centers). Mortality decreased from 27.8% before to 19.9% after surfactant therapy was introduced (Mantel-Haenszel chi 2 = 31.4, P = .001). The adjusted odds ratio for mortality after surfactants became available was 0.73 (95% confidence interval 0.55 to 0.95). The duration of assisted ventilation and length of hospitalization increased after surfactants were introduced (P = .0001 for both outcomes). CONCLUSION: Mortality for neonates weighing 601 to 1300 g decreased after surfactant therapy was introduced, suggesting that the efficacy of surfactants demonstrated in randomized controlled trials will translate into effectiveness in routine clinical care.

The newborn oxygram: automated processing of transcutaneous oxygen data.

Hypoxemic and hyperoxemic episodes are common in newborns with respiratory disorders. We have developed a microprocessor-based data system for use with transcutaneous oxygen (TcPO2) monitors in an attempt to quantitate these episodes. The amount of time spent by an infant in each of ten preset TcPO2 ranges can be automatically recorded. These data are referred to as the oxygram. Fourteen newborn infants were monitored for a total of 552 hours using this system. They spent a mean of 2.96% of the time with a TcPO2 less than or equal to 40 torr and 0.26% of the time with a TcPO2 greater than 100 torr. Representative oxygrams are presented. Clinical and research applications of the data system are discussed.

Effect of application force on noninvasive measurements of intracranial pressure.

Application of the Ladd fiberoptic sensor to the anterior fontanel of the human newborn has been used as a method for monitoring intracranial pressure noninvasively. This study measures the effect of varying the force with which the sensor is applied to the fontanel. The Ladd sensor readings of five preterm human infants were continuously monitored while sensor application force was increased in a stepwise manner. The Ladd sensor readings for each infant varied with the force applied. In one infant sensor application was gradually increased while direct measurements of lumbar CSF pressure were made. Ladd sensor readings in this infant increased with increasing application force, while lumbar CSF pressure remained unchanged. It is concluded that readings obtained with the Ladd sensor applied to the anterior fontanel of the human infant depend on the force with which the sensor is applied. The effect of application force must be taken into account if noninvasive measurements of intracranial pressure are to be made with the Ladd device.

Cardiopulmonary resuscitation in the very low birth weight infant: the Vermont Oxford Network experience.

OBJECTIVE: The limited literature available to date suggests that the use of delivery room cardiopulmonary resuscitation (DR-CPR) is associated with very poor outcomes, especially for extremely low birth weight infants. We reviewed the cumulative experience of the Vermont Oxford Network to determine the actual utilization of DR-CPR and the neonatal outcomes of such infants. METHODS: A retrospective review of information available in the Vermont Oxford Network Database for the years 1994 to 1996. The data set was collected from 196 neonatal units who participate in the Network (data for infants 401 to 500 g were from 1996 only). Infants were eligible for study if they received DR-CPR defined as the administration of chest compressions and/or epinephrine in the delivery room as noted on the Vermont Oxford Network Database record. RESULTS: Information regarding survival was available for 27 707 newborns with birth weights from 501 to 1500 g, and 497 infants with birth weights from 401 to 500 g. There were 24 001 (86.6%) survivors. Overall DR-CPR was given to 9.3% of infants from 401 to 500 g and 6% of infants from 501 to 1500 g, 82.1% receiving chest compressions, and 66.7% receiving epinephrine. Survival of infants receiving DR-CPR was 23. 9% for infants of 401 to 500 g, and 63.3% for infants of 501 to 1500 g, compared with 16.7% and 87.9% for infants in these weight groups not receiving DR-CPR. Survival was greater for infants of 501 g or greater without DR-CPR compared with those who received this intervention within each 250-g birth weight subgroup. For infants of <1000 g, survival was 53.8% with DR-CPR compared with 74.9% without. Head ultrasounds were available for 95.5% of all surviving infants and 96.7% of infants who received DR-CPR. Overall, any grade of intraventricular hemorrhage (IVH) occurred more frequently in infants who received DR-CPR (38%) than in those who did not (21%). Grade 3 or 4 (severe) IVH was seen in 15.3% of infants who received DR-CPR compared with 4.9% of the infants who did not. Overall, survival without severe IVH occurred in 52.2% of DR-CPR infants compared with 81.3% of infants who did not require this intervention. CONCLUSION: The majority of very low birth weight and extremely low birth weight infants who receive DR-CPR survive, and at least half of such infants who survive do not have evidence of severe IVH. Further follow-up studies are required to determine the long-term neurodevelopmental outcome of such infants. The current study does not support the previously noted poor outcome in extremely low birth weight infants who receive DR-CPR.

Very low birth weight outcomes of the National Institute of Child Health and Human Development Neonatal Network.

This report describes the neonatal outcomes of 1765 very low birth weight (less than 1500 g) infants delivered from November 1987 through October 1988 at the seven participating centers of the National Institute of Child Health and Human Development Neonatal Intensive Care Network. Survival was 34% at less than 751 g birth weight (range between centers 20% to 55%), 66% at 751 through 1000 g (range 42% to 75%), 87% at 1001 through 1250 g (range 84% to 91%), and 93% at 1251 through 1500 g (range 89% to 98%). By obstetric measures of gestation, survival was 23% at 23 weeks (range 0% to 33%), 34% at 24 weeks (range 10% to 57%), and 54% at 25 weeks (range 30% to 72%). Neonatal morbidity included respiratory distress (67%), symptomatic patent ductus arteriosus (25%), necrotizing enterocolitis (6%), septicemia (17%), meningitis (2%), urinary tract infection (4%), and intraventricular hemorrhage (45%, 18% grade III and IV). Morbidity increased with decreasing birth weight. Oxygen was administered for greater than or equal to 28 days to 79% of less than 751-g birth weight infants (range between centers 67% to 100%), 45% of 751- through 1000-g infants (range 20% to 68%), and 13% of 1001- through 1500-g infants (range 5% to 23%). Ventilator support for greater than or equal to 28 days was given to 68% of infants at less than 751 g, 29% at 751 through 1000 g, and 4% at greater than 1000 g. Hospital stay was 59 days for survivors vs 15 days for infants who died. Sixty-nine percent of survivors had subnormal (less than 10th percentile) weight at discharge. The data demonstrate important intercenter variation of current neonatal outcomes, as well as differences in philosophy of care and definition and prevalence of morbidity.

Ultrasound detection of changing ventricular size in posthemorrhagic hydrocephalus.

Real time ultrasonography has been used to follow sequentially the changing size of the cerebral ventricles in an infant with posthemorrhagic hydrocephalus. A method for quantitating ventricular size is presented and the rapidity with which ventricular size decreases following removal of cerebrospinal fluid is demonstrated.

Variability in 28-day outcomes for very low birth weight infants: an analysis of 11 neonatal intensive care units.

A retrospective study of all infants weighing 701 to 1,500 g born at 11 neonatal intensive care centers during 1983 and 1984 was performed to determine whether two specific 28-day outcomes, survival and survival without the need for supplemental oxygen, varied among the centers. Survival without the need for supplemental oxygen was chosen as a reflection of infants surviving without chronic lung disease. There were 1,776 live-born infants delivered during the 2-year study period. Of these infants, 85% (1,512) survived 28 days, a range of 80% to 92% at the individual centers. A total of 60% (1,056) of the infants were alive without supplemental oxygen on day 28, a range of 51% to 70% at the individual centers. Multivariate analysis demonstrated that both survival on day 28 (chi 2 = 23.9, P less than .01) and survival without supplemental oxygen on day 28 (chi 2 = 44.2, P less than .0001) varied significantly among centers after the effects of birth weight, gender, and race were taken into account. Female gender, nonwhite race, and increased birth weight were factors associated with improved rates of survival and survival without supplemental oxygen. The magnitude of outcome variation among centers was estimated by using the logistic regression models to predict what the outcomes would be if each center were to treat a standardized population consisting of all 1,776 study infants.(ABSTRACT TRUNCATED AT 250 WORDS)

Randomized controlled trial of exogenous surfactant for the treatment of hyaline membrane disease.

We conducted a prospective, randomized, unblinded, controlled trial of exogenous bovine surfactant (surfactant TA) in premature infants requiring ventilator support for the treatment of severe hyaline membrane disease. Forty-one low birth weight infants with severe hyaline membrane disease were randomly assigned to saline or surfactant therapy and treated within eight hours of birth. Significant improvements in oxygenation (increased arterial/alveolar PO2) and respiratory support (decreased mean airway pressure) were seen in the group receiving surfactant within four hours after treatment. These improvements were maintained in the surfactant-treated infants, who also had fewer pneumothoraces and fewer number of days in environments of fractional inspiratory oxygen greater than 0.4 mm Hg. No problems were associated with administration of surfactant, and no acute side effects were detected. We conclude that exogenous surfactant, administered early in the course of severe hyaline membrane disease, is an effective therapy that can diminish the amount of respiratory support required during the first 48 hours of life.

Birthweight-adjusted mortality rates for assessing the effectiveness of neonatal intensive care.

Mortality rates for very-low-birthweight infants vary significantly among different neonatal intensive care units (NICUs). Computational models and computer simulation are used to predict the performance of an algorithm for identifying individual NICUs within a network that have greater than 110% of the expected birthweight-adjusted mortality risk. The algorithm maintains high sensitivity and specificity with as few as three moderately heterogeneous risk categories when applied to large health care networks; the model parameters were based on preliminary data from a real NICU network. The performance of the algorithm depends on the number of admissions at the individual NICU. A NICU with a center-specific risk 130% of the network average would be correctly identified as an outlier 50% of the time if it had 35 admissions, 59% of the time if it had 70 admissions, and 77% of the time if it had 280 admissions. A NICU with average risk would be incorrectly identified as an outlier 16%, 12%, or 2% of the time if it had 35, 70, or 280 admissions, respectively. Severity-of-illness casemix adjustment did not improve these results. It is concluded that the sensitivity and specificity of the algorithm in determining which facilities have higher-than-expected mortality will be less in typical NICU networks than in large health care networks that treat adult patients. It is unlikely that severity-of-illness adjustments will overcome the problem of the small numbers of admissions at individual NICUs.

Increasing use of antenatal corticosteroid therapy between 1990 and 1993 in Vermont Oxford Network.

OBJECTIVE: The purpose of this study was to determine whether the frequency of antenatal corticosteroid treatment changed between 1990 and 1993 and to identify patient characteristics associated with the use of this treatment. STUDY DESIGN: A total of 17,335 infants born in the years 1990 to 1993 with birth weights of 1500 gm or less and gestational ages of 24 to 34 weeks who were cared for at one of the 94 institutions participating in the Vermont Oxford Network were included in the study. Ninety-one infants were excluded from analysis because of missing data, resulting in a final sample of 17,244 infants. RESULTS: The percentage of infants whose mothers received antenatal corticosteroid treatment increased steadily during the 4-year study period (19.3% in 1990, 24.8% in 1991, 28.6% in 1992, and 34.1% in 1993; p < 0.001 by chi square test for trend in proportions). The results of a logistic regression analysis indicated that increasing year of birth, inborn location of birth, prenatal care, and multiple birth were associated with an increased use of antenatal corticosteroid treatment; black race and small size for gestational age were associated with decreased use of the treatment. In 1993, the median percentage of infants at an individual institution whose mothers received antenatal corticosteroid treatment was 25%; 10% of institutions had percentages less than 7% and 10% had percentages higher than 60%. CONCLUSION: Although the use of antenatal corticosteroid treatment increased steadily during the study period, this treatment was still used infrequently at many institutions in 1993. Considerable improvements in outcomes for preterm infants can be achieved if the recommendations of the National Institutes of Health Consensus Development Panel regarding more widespread use of antenatal corticosteroid treatment are adopted by health professionals who provide medical care to pregnant women.

Episodic abnormalities in transcutaneous oxygen (TcPO2) recorded during neonatal intensive care.

An automated TcPO2 data system was tested and used to: 1) quantitate the frequency and duration of hypoxemic and hyperoxemic events experienced during the first three days after birth by 25 very low birth weight infants, and 2) determine whether hypoxemic events were associated with the occurrence of periventricular-intraventricular hemorrhage. During the first three days after birth, infants experienced a median of 41 episodes with a TcPO2 less than 40 torr having a cumulative duration of 37 minutes, and a median of 28 episodes with a TcPO2 greater than 100 torr having a cumulative duration of 14 minutes. Most episodes were less than 30 seconds in duration, but in some infants the duration was longer. There was no association between the occurrence of periventricular-intraventricular hemorrhage and either the frequency or cumulative duration of episodes with a TcPO2 less than 40 torr. A major problem with automated TcPO2 data systems is the inability of currently available systems to recognize inaccurate TcPO2 data. Twenty-four per cent of the summary TcPO2 monitoring data collected in this study was contaminated with unreliable TcPO2 values. Before automated TcPO2 data systems can be recommended for widespread research use or for medicolegal documentation, the problem of data contamination must be resolved.

Real time patient safety audits: improving safety every day.

BACKGROUND: Timely error detection including feedback to clinical staff is a prerequisite for focused improvement in patient safety. Real time auditing, the efficacy of which has been repeatedly demonstrated in industry, has not been used previously to evaluate patient safety. Methods successful at improving quality and safety in industry may provide avenues for improvement in patient safety. OBJECTIVE: Pilot study to determine the feasibility and utility of real time safety auditing during routine clinical work in an intensive care unit (ICU). METHODS: A 36 item patient safety checklist was developed via a modified Delphi technique. The checklist focused on errors associated with delays in care, equipment failure, diagnostic studies, information transfer and non-compliance with hospital policy. Safety audits were performed using the checklist during and after morning work rounds thrice weekly during the 5 week study period from January to March 2003. RESULTS: A total of 338 errors were detected; 27 (75%) of the 36 items on the checklist detected >or=1 error. Diverse error types were found including unlabeled medication at the bedside (n = 31), ID band missing or in an inappropriate location (n = 70), inappropriate pulse oximeter alarm setting (n = 22), and delay in communication/information transfer that led to a delay in appropriate care (n = 4). CONCLUSIONS: Real time safety audits performed during routine work can detect a broad range of errors. Significant safety problems were detected promptly, leading to rapid changes in policy and practice. Staff acceptance was facilitated by fostering a blame free "culture of patient safety" involving clinical personnel in detection of remediable gaps in performance, and limiting the burden of data collection.

A computer simulation of medical decision strategy performance.

This study demonstrates a computer model which can be used to compare the effects of errors in probability and utility estimation on the performance of Bayesian and alternative medical decision strategies. The model task requires choosing one of three treatments for a patient with one of three diseases based on the patient's state with respect to five binary cues and estimates of the prior probabilities of disease, the conditional probabilities of the cues and the utilities of the treatments. A classic decision analytic strategy uses Bayes' formula to calculate posterior probabilities of disease and chooses treatments based on maximization of expected value. Alternative strategies use likelihood ratios to calculate disease scores for each patient state and choose the treatment with highest payoff for the disease with the highest score. Two strategies with different cutoffs for the ratios are compared with a random strategy and a classic decision analytic strategy. The simulation results show that the payoffs for all strategies except the random strategy decline with increasing estimation error. The decision analytic strategy has the highest mean payoff at all levels of error. The differences between this optical strategy and the alternatives, however, decrease as estimation error increases, and the frequency with which the strategies based on simple diagnostic scoring rules outperform the formal Bayesian strategy increases.

A calculator program for determining indices of neonatal respiratory distress syndrome severity.

The potential for treating and preventing neonatal respiratory distress syndrome (RDS) with exogenous surfactant has created renewed interest in quantitative measures and derived scores that can be used to assess disease severity. Many different indices of RDS severity have been suggested. They are useful as outcome measures in clinical trials and may assist in the early identification of infants at risk for severe complications. In this article, a program for the Hewlett-Packard 41CV programmable calculator is presented that calculates indices of RDS severity based on ventilator settings and arterial blood gas values.

Revising ranked probabilities: a Bayesian approach to incomplete knowledge.

Incomplete knowledge refers to situations in which a decision maker can rank the probabilities of occurrence for events of interest, but cannot specify these probabilities exactly. In this paper a Monte Carlo approach is used to investigate how physicians can arrive at revised or posterior rankings of disease probability given only rank order information about both the patient's prior probabilities of disease and the conditional probabilities of specific clinical findings for each disease. Computer-generated estimates of the expected frequencies of the posterior rankings are presented for the cases of 2, 3, and 4 disease states. The application of probability revision under conditions of incomplete knowledge to therapeutic decision making is discussed.

The Vermont Oxford Network: evidence-based quality improvement for neonatology.

The Vermont Oxford Network is a voluntary collaborative group of health professionals committed to improving the effectiveness and efficiency of medical care for newborn infants and their families through a coordinated program of research, education, and quality-improvement projects. In support of these activities, the Network maintains a clinical database of information about very low birth weight infants that now has more than 300 participating neonatal intensive care units (NICUs). We anticipate that these NICUs will submit data for 25 000 infants with birth weights of 401 to 1500 g born in 1998. The research program of the Network includes outcomes research and randomized clinical trials. The goal of Network outcomes research is to identify and explain the variations in clinical practice and patient outcomes that are apparent among NICUs. Network trials are designed to answer practical questions of importance to practitioners and families using pragmatic designs that can be integrated into the daily practice of neonatology. Quality improvement is a major focus of the Network. Members receive confidential quarterly and annual reports based on the Network database that document their performance and compare practices and outcomes at their unit with those at other units within the Network. These reports are intended to assist the members in identifying opportunities for improvement and to help them monitor the success of their improvement efforts. Although information is necessary for improvement to occur, it is not sufficient to foster lasting improvement by itself. Information must be translated into action. The Network is sponsoring an ongoing program of quality initiatives designed to provide members with the knowledge, skills, tools, and resources needed to foster action for improvement. The Network's first formal quality-improvement project, the NIC/Q Project, brought together 10 NICUs to apply the methods of collaborative improvement and benchmarking to neonatal intensive care. Building on the lessons learned in that initial project, the Network now is conducting the Vermont Oxford Network Evidence-Based Quality Improvement Collaborative for Neonatology, known as NIC/Q 2000. This 2-year collaborative will assist multidisciplinary teams from the 34 participating NICUs to develop four key habits for improvement: the habit for change, the habit for practice as a process, the habit for collaborative learning, and the habit for evidence-based practice. During the collaborative, participants will contribute to a knowledge bank of clinical, organizational, and operational change ideas for improving neonatal care. The coordinated program of research, education, and quality improvement described in this article is only possible because of the voluntary efforts of the members. The Network will continue to support these efforts by developing and providing improved tools and resources for the practice of evidence-based neonatology.neonatology, very low birth weight, database, network, quality improvement, evidence-based medicine, randomization, trials, outcomes, mortality, length of stay.

Evaluation of neonatal intensive care technologies.

The development and dissemination of neonatal intensive care technology has been associated with improved survival for critically ill newborn infants, particularly those with birth weights of less than 1,500 grams (3 pounds, 5 ounces). Despite these advances, there are concerns about the long-term health status of surviving infants and the costs of their initial and subsequent care. In this article, the authors review current evidence for the effectiveness of neonatal intensive care and discuss several approaches to evaluating neonatal intensive care technology. They discuss a four-step process originally proposed by Roper for assessing and improving neonatal intensive care practices which includes (1) monitoring of practices, outcomes, and costs; (2) analysis of variation in practices, outcomes, and costs; (3) assessment of the efficacy of individual interventions, and (4) feedback and education to alter clinical behavior. The authors conclude that organized networks of neonatal intensive care units can play a crucial role in this process.