Building the Driver Diagram: A Mixed-Methods Approach to Identify Causes of Unplanned Extubations in a Large Neonatal ICU.

BACKGROUND: The key driver diagram (KDD) is an important tool used by improvement teams to guide and frame their work. Methods to build a KDD when little relevant literature or reliable local data exist are poorly described. This article describes the process used in our neonatal ICU (NICU) to build a KDD to decrease unplanned extubations (UE) in chronically ventilated infants. METHODS: Twenty-seven factors hypothesized to be associated with UE in our NICU were identified. An expert panel of 33 staff members completed three rounds of a modified Delphi process administered through an online interface. After the third round, panel members provided suggestions for interventions to target all factors meeting criteria for consensus. These qualitative data were analyzed by inductive thematic analysis. A follow-up survey to all panel members was used to assess the feasibility of this process for future use. RESULTS: After three Delphi rounds, 14 factors met consensus and eight main interventions were identified through thematic analysis. These data were used to build a KDD for testing. All participants who completed the follow-up survey (20/20) stated willingness to participate in this process in the future and 18/20 (90%) stated they would be "more willing" or "much more willing" to support interventions developed using this process. CONCLUSION: A novel mixed-methods approach was used to generate a KDD combining a Delphi process with thematic analysis. This approach provides improvement teams a rigorous and reproducible method to understand local context, generate consensus KDDs, and improve local buy-in for improvement interventions.

Pathogenetics of alveolar capillary dysplasia with misalignment of pulmonary veins.

Alveolar capillary dysplasia with misalignment of pulmonary veins (ACDMPV) is a lethal lung developmental disorder caused by heterozygous point mutations or genomic deletion copy-number variants (CNVs) of FOXF1 or its upstream enhancer involving fetal lung-expressed long noncoding RNA genes LINC01081 and LINC01082. Using custom-designed array comparative genomic hybridization, Sanger sequencing, whole exome sequencing (WES), and bioinformatic analyses, we studied 22 new unrelated families (20 postnatal and two prenatal) with clinically diagnosed ACDMPV. We describe novel deletion CNVs at the FOXF1 locus in 13 unrelated ACDMPV patients. Together with the previously reported cases, all 31 genomic deletions in 16q24.1, pathogenic for ACDMPV, for which parental origin was determined, arose de novo with 30 of them occurring on the maternally inherited chromosome 16, strongly implicating genomic imprinting of the FOXF1 locus in human lungs. Surprisingly, we have also identified four ACDMPV families with the pathogenic variants in the FOXF1 locus that arose on paternal chromosome 16. Interestingly, a combination of the severe cardiac defects, including hypoplastic left heart, and single umbilical artery were observed only in children with deletion CNVs involving FOXF1 and its upstream enhancer. Our data demonstrate that genomic imprinting at 16q24.1 plays an important role in variable ACDMPV manifestation likely through long-range regulation of FOXF1 expression, and may be also responsible for key phenotypic features of maternal uniparental disomy 16. Moreover, in one family, WES revealed a de novo missense variant in ESRP1, potentially implicating FGF signaling in the etiology of ACDMPV.

Endotracheal Intubation in Neonates: A Prospective Study of Adverse Safety Events in 162 Infants.

OBJECTIVE: To determine the rate of adverse events associated with endotracheal intubation in newborns and modifiable factors contributing to these events. STUDY DESIGN: We conducted a prospective, observational study in a 100-bed, academic, level IV neonatal intensive care unit from September 2013 through June 2014. We collected data on intubations using standardized data collection instruments with validation by medical record review. Intubations in the delivery or operating rooms were excluded. The primary outcome was an intubation with any adverse event. Adverse events were defined and tracked prospectively as nonsevere or severe. We measured clinical variables including number of attempts to successful intubation and intubation urgency (elective, urgent, or emergent). We used logistic regression models to estimate the association of these variables with adverse events. RESULTS: During the study period, 304 intubations occurred in 178 infants. Data were available for 273 intubations (90%) in 162 patients. Adverse events occurred in 107 (39%) intubations with nonsevere and severe events in 96 (35%) and 24 (8.8%) intubations, respectively. Increasing number of intubation attempts (OR 2.1, 95% CI, 1.6-2.6) and emergent intubations (OR 4.7, 95% CI, 1.7-13) were predictors of adverse events. The primary cause of emergent intubations was unplanned extubation (62%). CONCLUSIONS: Adverse events are common in the neonatal intensive care unit, occurring in 4 of 10 intubations. The odds of an adverse event doubled with increasing number of attempts and quadrupled in the emergent setting. Quality improvement efforts to address these factors are needed to improve patient safety.

Increasing Volume-Targeted Ventilation Use in the NICU.

BACKGROUND: In preterm infants who require mechanical ventilation (MV), volume-targeted ventilation (VTV) modes are associated with lower rates of bronchopulmonary dysplasia compared with pressure-limited ventilation. Bronchopulmonary dysplasia rates in our NICU were higher than desired, prompting quality improvement initiatives to improve MV by increasing the use of VTV. METHODS: We implemented and tested interventions over a 3-year period. Primary outcomes were the percentage of conventional MV hours when any-VTV mode was used and the percentage of conventional MV hours when an exclusively VTV mode was used. Exclusively VTV modes were modes in which all breaths were volume targeted. We evaluated outcomes during 3 project periods: baseline (May 2016-December 2016); epoch 1 (December 2016-October 2018), increasing the use of any-VTV mode; and epoch 2 (October 2018-November 2019), increasing the use of exclusively VTV modes. RESULTS: Use of any-VTV mode increased from 18 694 of 22 387 (83%) MV hours during baseline to 72 846 of 77 264 (94%) and 58 174 of 60 605 (96%) MV hours during epochs 1 and 2, respectively (P < .001). Use of exclusively VTV increased from 5967 of 22 387 (27%) during baseline to 47 364 of 77 264 (61%) and 46 091 of 60 605 (76%) of all conventional MV hours during epochs 1 and 2, respectively (P < .001). In statistical process control analyses, multiple interventions were associated with improvements in primary outcomes. Measured clinical outcomes were unchanged. CONCLUSIONS: Quality improvement interventions were associated with improved use of VTV but no change in measured clinical outcomes.

Implementing Strategies to Identify and Mitigate Adverse Safety Events: A Case Study with Unplanned Extubations.

BACKGROUND: Patient safety events result from failures in complex health care delivery processes. To ensure safety, teams must implement ways to identify events that occur in a nonrandom fashion and respond in a timely manner. To illustrate this, one children's hospital's experience with an outbreak of unplanned extubations (UEs) in the neonatal ICU (NICU) is described. METHODS: The quality improvement team measured UEs using three complementary data streams. Interventions to decrease the rate of UE were tested with success. Three statistical process control (SPC) charts (u-chart, g-chart, and an exponentially weighted moving average [EWMA] chart) were used for real-time monitoring. RESULTS: From July 2015 to May 2016, the UE rate was stable at 1.1 UE/100 ventilator days. In early June 2016, a cluster of UEs, including four events within one week, was observed. Two of three SPC charts showed special cause variation, although at different time points. The EWMA chart alerted the team more than two weeks earlier than the u-chart. Within days of discovering the outbreak, the team identified that the hospital had replaced the tape used to secure endotracheal tubes with a nearly identical product. After multiple tape products were tested over the next month, the team selected one that returned the system to a state of stability. CONCLUSION: Ongoing monitoring using SPC charts allowed early detection and rapid mitigation of an outbreak of UEs in the NICU. This highlights the importance of continuous monitoring using tools such as SPC charts that can alert teams to both improvement and worsening of processes.

Interventions to Improve Patient Safety During Intubation in the Neonatal Intensive Care Unit.

OBJECTIVE: To improve patient safety in our NICU by decreasing the incidence of intubation-associated adverse events (AEs). METHODS: We sequentially implemented and tested 3 interventions: standardized checklist for intubation, premedication algorithm, and computerized provider order entry set for intubation. We compared baseline data collected over 10 months (period 1) with data collected over a 10-month intervention and sustainment period (period 2). Outcomes were the percentage of intubations containing any prospectively defined AE and intubations with bradycardia or hypoxemia. We followed process measures for each intervention. We used risk ratios (RRs) and statistical process control methods in a times series design to assess differences between the 2 periods. RESULTS: AEs occurred in 126/273 (46%) intubations during period 1 and 85/236 (36%) intubations during period 2 (RR = 0.78; 95% confidence interval [CI], 0.63-0.97). Significantly fewer intubations with bradycardia (24.2% vs 9.3%, RR = 0.39; 95% CI, 0.25-0.61) and hypoxemia (44.3% vs 33.1%, RR = 0.75, 95% CI 0.6-0.93) occurred during period 2. Using statistical process control methods, we identified 2 cases of special cause variation with a sustained decrease in AEs and bradycardia after implementation of our checklist. All process measures increased reflecting sustained improvement throughout data collection. CONCLUSIONS: Our interventions resulted in a 10% absolute reduction in AEs that was sustained. Implementation of a standardized checklist for intubation made the greatest impact, with reductions in both AEs and bradycardia.