Preventing Cardiac Arrest in the Pediatric Cardiac Intensive Care Unit Through Multicenter Collaboration.

Importance: Preventing in-hospital cardiac arrest (IHCA) likely represents an effective strategy to improve outcomes for critically ill patients, but feasibility of IHCA prevention remains unclear. Objective: To determine whether a low-technology cardiac arrest prevention (CAP) practice bundle decreases IHCA rate. Design, Setting, and Participants: Pediatric cardiac intensive care unit (CICU) teams from the Pediatric Cardiac Critical Care Consortium (PC4) formed a collaborative learning network to implement the CAP bundle consistent with the Institute for Healthcare Improvement framework; 15 hospitals implemented the bundle voluntarily. Risk-adjusted IHCA incidence rates were analyzed across 2 time periods, 12 months (baseline) and 18 months after CAP implementation (intervention) using difference-in-differences (DID) regression to compare 15 CAP and 16 control PC4 hospitals that chose not to participate in CAP but had IHCA rates tracked in the PC4 registry. Patients deemed at high risk for IHCA, based on a priori evidence-based criteria and empirical hospital-specific criteria, were selected to receive the CAP bundle. Data were collected from July 2018 to December 2019, and data were analyzed from March to August 2020. Interventions: CAP bundle included 5 elements developed to promote increased situational awareness and communication among bedside clinicians to recognize and mitigate deterioration in high-risk patients. Main Outcomes and Measures: Risk-adjusted IHCA incidence rate across all CICU admissions (IHCA events divided by all admissions). Results: The bundle was activated in 2664 of 10 510 CAP hospital admissions (25.3%); admission characteristics were similar across study periods. There was a 30% relative reduction in risk-adjusted IHCA incidence rate at CAP hospitals (intervention period: 2.6%; 95% CI, 2.2-2.9; baseline: 3.7%; 95% CI, 3.1-4.0), but no change at control hospitals (intervention period: 2.7%; 95% CI, 2.3-2.9; baseline: 2.7%; 95% CI, 2.2-3.0). DID analysis confirmed significantly reduced odds of IHCA among all admissions at CAP hospitals compared with control hospitals during the intervention period vs baseline (odds ratio, 0.72; 95% CI, 0.56-0.91; P = .01). DID odds ratios were 0.72 (95% CI, 0.53-0.98) for the surgical subgroup, 0.74 (95% CI, 0.48-1.14) for the medical subgroup, and 0.72 (95% CI, 0.50-1.03) for the high-risk admission subgroup at CAP hospitals after intervention. All-cause risk-adjusted mortality rate did not change after intervention. Conclusions and Relevance: Implementation of this CAP bundle led to significant IHCA reduction across multiple pediatric CICUs. Future studies may determine if this bundle can be effective in other critically ill populations.

Vasopressin rescue for in-pediatric intensive care unit cardiopulmonary arrest refractory to initial epinephrine dosing: a prospective feasibility pilot trial.

OBJECTIVES: To assess the feasibility of a large, randomized controlled trial of combination epinephrine-arginine vasopressin for in-pediatric intensive care unit cardiopulmonary arrest refractory to initial epinephrine dosing. DESIGN: Prospective, pilot, matched controlled clinical trial using exception from informed consent. SETTING: Pediatric intensive care unit in a university-affiliated tertiary care children's hospital. PATIENTS: All patients <18 yrs of age admitted to the pediatric intensive care unit with cardiopulmonary arrest requiring chest compressions and epinephrine (0.01 mg/kg) were eligible. INTERVENTIONS: Patients who remained in cardiopulmonary arrest despite an initial dose of epinephrine received arginine vasopressin (0.8 U/kg) rescue as the second vasopressor, followed by additional epinephrine if needed. MEASUREMENTS AND MAIN RESULTS: Outcome variables included return of spontaneous circulation (≥20 min), survival at 24 hrs, survival to hospital discharge, and neurologic status at discharge. Favorable neurologic status was defined as Pediatric Cerebral Performance Categories 1, 2, and 3, or no change from admission. Data were compared to a retrospective, matched cohort of patients who experienced cardiopulmonary arrest requiring ≥ two doses of vasopressor, and did not receive arginine vasopressin (n = 20). Of 2,654 patients admitted to the pediatric intensive care unit, 29 (1.1%) had refractory cardiopulmonary arrest: five patients were excluded, 14 missed for inclusion, and ten were enrolled. There was increased 24-hr survival (80% vs. 30%, odds ratio 9.33, 95% confidence interval 1.51-57.65) in arginine vasopressin patients. There was no significant difference in return of spontaneous circulation, survival to hospital discharge, or favorable neurologic status at discharge. CONCLUSIONS: These pilot data provide support for a larger randomized controlled trial of arginine vasopressin therapy during cardiopulmonary resuscitation for in-hospital pediatric cardiac arrest.

Effectiveness of the informed consent process for a pediatric resuscitation trial.

OBJECTIVE: When prospective informed consent is not feasible, clinical research that presents more than minimal risk can proceed only with an exception from informed consent. Our objectives were (1) to describe the in-hospital community consultation and public disclosure process for a clinical trial and (2) to evaluate our in-hospital public disclosure process. METHODS: Community consultation included parents, providers, and administrators in a PICU via focus groups, conferences, and other methods. Public disclosure consisted of a brochure and a poster in all PICU waiting rooms. These materials described risks and benefits of the trial, that no consent would be sought, how to "opt out," and how to provide feedback. A verbal questionnaire was administered to parents of potential patients during the trial to evaluate the public disclosure process. RESULTS: Eighty-one percent of 93 parents were aware of the ongoing trial. Seventy-six of 93 remembered seeing the brochure; of these, 26% did not read, 39% read quickly, and 35% read carefully. Thirty-seven of 93 parents remembered seeing the poster; of these, 51% did not read, 32% read quickly, and 17% read carefully. Sixty-seven percent reported that they would want to participate in the study, 9% would not, and 24% were undecided. Of the 7 parents who did not want to participate, 3 had opted out and 4 were unaware that they could opt out. CONCLUSIONS: Parents endorsed resuscitation research with an exception from informed consent. Public disclosure yielded >80% parental awareness. Efforts should be made to ensure awareness of the ability to opt out.