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The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:The "Age of Blood in Children in Pediatric Intensive Care Unit" (ABC PICU) study is a randomized controlled trial (RCT) that aims to determine if red blood cell (RBC) unit storage age affects outcomes in critically ill children. While RBCs can be stored for up to 42 days in additive solutions, their efficacy and safety after long-term storage have been challenged. Preclinical and clinical observational evidence suggests loss of efficacy and lack of safety of older RBC units, especially in more vulnerable populations such as critically ill children. Because there is a belief that shorter storage will improve outcomes, some physicians and institutions systematically transfuse fresh RBCs to children. Conversely, the standard practice of blood banks is to deliver the oldest available RBC unit (first-in, first-out policy) in order to decrease wastage. METHODS/DESIGN:The ABC PICU study, is a double-blind superiority trial comparing the development of "New or Progressive Multiple Organ Dysfunction Syndrome" (NPMODS) in 1538 critically ill children randomized to either transfusion with RBCs stored for ??7 days or to standard-issue RBCs (oldest in inventory). Patients are being recruited from 52 centers in the US, Canada, France, Italy, and Israel. DISCUSSION:The ABC PICU study should have significant implications for blood procurement services. A relative risk reduction of 33% is postulated in the short-storage arm. If a difference is found, this will indicate that fresher RBCs do improve outcomes in the pediatric intensive care unit population and would justify that use in critically ill children. If no difference is found, this will reassure clinicians and transfusion medicine specialists regarding the safety of the current system of allocating the oldest RBC unit in inventory and will discourage clinicians from preferentially requesting fresher blood for critically ill children. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT01977547 . Registered on 6 November 2013.

SUBMITTER: Tucci M

PROVIDER: S-EPMC6064163 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial.

Tucci Marisa M Lacroix Jacques J Fergusson Dean D Doctor Allan A Hébert Paul P Berg Robert A RA Caro Jaime J Josephson Cassandra D CD Leteurtre Stéphane S Menon Kusum K Schechtman Kenneth K Steiner Marie E ME Turgeon Alexis F AF Clayton Lucy L Bockelmann Tina T Spinella Philip C PC

Trials 20180728 1

<h4>Background</h4>The "Age of Blood in Children in Pediatric Intensive Care Unit" (ABC PICU) study is a randomized controlled trial (RCT) that aims to determine if red blood cell (RBC) unit storage age affects outcomes in critically ill children. While RBCs can be stored for up to 42 days in additive solutions, their efficacy and safety after long-term storage have been challenged. Preclinical and clinical observational evidence suggests loss of efficacy and lack of safety of older RBC units, e ...[more]

PMID: 30055634

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Project description:BackgroundTelemedicine has been deployed to address issues in intensive care delivery, as well as to improve outcome and quality of care. Implementation of this technology has been characterized by high variability. Tele-intensive care unit (ICU) interventions involve the combination of multiple technological and organizational components, as well as interconnections of key stakeholders inside the hospital organization. The extensive literature on the benefits of tele-ICUs has been characterized as heterogeneous. On one hand, positive clinical and economical outcomes have been shown in multiple studies. On the other hand, no tangible benefits could be detected in several cases. This could be due to the diverse forms of organizations and the fact that tele-ICU interventions are complex to evaluate. The implementation context of tele-ICUs has been shown to play an important role in the success of the technology. The benefits derived from tele-ICUs depend on the organization where it is deployed and how the telemedicine systems are applied. There is therefore value in analyzing the benefits of tele-ICUs in relation to the characteristics of the organization where it is deployed. To date, research on the topic has not provided a comprehensive overview of literature taking both the technology setup and implementation context into account.ObjectiveWe present a protocol for a scoping review of the literature on telemedicine in the ICU and its benefits in intensive care. The purpose of this review is to map out evidence about telemedicine in critical care in light of the implementation context. This review could represent a valuable contribution to support the development of tele-ICU technologies and offer perspectives on possible configurations, based on the implementation context and use case.MethodsWe have followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist and the recommendations of the Joanna Briggs Institute methodology for scoping reviews. The scoping review and subsequent systematic review will be completed by spring 2021.ResultsThe preliminary search has been conducted. After removing all duplicates, we found 2530 results. The review can now be advanced to the next steps of the methodology, including literature database queries with appropriate keywords, retrieval of the results in a reference management tool, and screening of titles and abstracts.ConclusionsThe results of the search indicate that there is sufficient literature to complete the scoping review. Upon completion, the scoping review will provide a map of existing evidence on tele-ICU systems given the implementation context. Findings of this research could be used by researchers, clinicians, and implementation teams as they determine the appropriate setup of new or existing tele-ICU systems. The need for future research contributions and systematic reviews will be identified.International registered report identifier (irrid)DERR1-10.2196/19695.

Project description:BACKGROUND:Every year, about 15 million of the world's infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [320/7] to 336/7 weeks) and late preterm (340/7 to 366/7 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs. METHODS:We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study. DISCUSSION:Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.

Project description:BACKGROUND:Healthcare-associated infections (HAIs) represent serious complications for patients within pediatric cardiac intensive care units (CICU). HAIs are associated with increased morbidity, mortality and resource utilization. There are few studies describing the epidemiology of HAIs across the entire spectrum of patients (surgical and nonsurgical) receiving care in dedicated pediatric CICUs. METHODS:Retrospective analyses of 22,839 CICU encounters from October 2013 to September 2016 across 22 North American CICUs contributing data to the Pediatric Cardiac Critical Care Consortium clinical registry. RESULTS:HAIs occurred in 2.4% of CICU encounters at a rate of 3.3 HAIs/1000 CICU days, with 73% of HAIs occurring in children <1 year. Eighty encounters (14%) had ?2 HAIs. Aggregate rates for the 4 primary HAIs are as follows: central line-associated blood stream infection, 1.1/1000 line days; catheter-associated urinary tract infections, 1.5/1000 catheter days; ventilator-associated pneumonia, 1.9/1000 ventilator days; surgical site infections, 0.81/100 operations. Surgical and nonsurgical patients had similar HAIs rates/1000 CICU days. Incidence was twice as high in surgical encounters and increased with surgical complexity; postoperative infection occurred in 2.8% of encounters. Prematurity, younger age, presence of congenital anomaly, Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery Congenital Heart Surgery Mortality Categories (STAT) 4-5 surgery, admission with an active medical condition, open sternum and extracorporeal membrane oxygenation were independently associated with HAIs. In univariable analysis, HAI was associated with longer hospital length of stay and durations of urinary catheter, central venous catheter and ventilation. Mortality was 24.4% in patients with HAIs versus 3.4% in those without, P < 0.0001. CONCLUSIONS:We provide comprehensive multicenter benchmark data regarding rates of HAIs within dedicated pediatric CICUs. We confirm that although rare, HAIs of all types are associated with significant resource utilization and mortality.

Project description:Staff in the paediatric intensive care unit work with children and their families in an area of high acuity, mortality, and morbidity. There is complexity due to technological advancements and confronting psychosocial situations. With increasing reports of the threat of burnout to healthcare professionals it is imperative to understand the prevalence of burnout and the determinants of risk factors for staff to work in the paediatric intensive care unit (PICU) in order to inform interventions that reduce risk and support growth and wellbeing of this specialised workforce. We conducted electronic searches of PUBMED, Medline, CINAHL and PsychINFO. Studies meeting eligibility inclusion criteria comprised English text, publication dates 1995 to 2019, use of standardized measures to assess prevalence and risk factors for burnout where the PICU staff data was reported separately and contained sample sizes ≥10 PICU staff. Two reviewers independently identified and extracted citations and assessed the quality of papers using two standardised reporting tools. Twenty studies were included in the final review. Due to the heterogeneity of the included studies a descriptive account of the studies was developed. Outcomes reported included prevalence and levels of burnout reported across professional disciplines, reported scoring criteria for burnout, risk and protective factors for burnout, comparative populations, systems and social context associated with burnout and study strengths and limitations. Most studies were cross-sectional, used a single measure of burnout and focussed on either physicians or nurses. Of the 20 studies reported 62% reported high burnout, 19% moderate burnout, and 19% reported low levels of burnout. Inconsistency was identified in adherence to recommended cut-off scores or reporting for the categorisation of burnout, which contributed to a lack of clarity in the interpretation of prevalence and severity. Reports of factors associated with increased risk and likely protective factors for burnout were often contradictory suggesting that burnout may be situational; dependent upon personal, environmental, leadership, cultural and patient factors within the PICU. This review revealed that determining levels and risk of burnout in PICU staff remains problematic. Further research which examines the experiences of all members of the multidisciplinary team and identification of factors that affect the development of burnout, including those which are protective, is required.

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The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial.

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The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial.

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