Enhancing Congenital Cardiac Postprocedural Care: A QR Code-Enabled Medical Bracelet Pilot Study.

The study aimed to evaluate the feasibility of using QR code-enabled medical bracelets for congenital heart disease (CHD) patients after hospital discharge to ensure quick communication of vital information to other medical personnel in emergency situations. A prospective study was conducted where QR code-enabled medical bracelets were given to families of postoperative pediatric cardiac patients. The QR code linked to a secure medical information sheet detailing the patient's cardiac history. Post-study surveys were completed by providers and families to assess their experiences with the bracelet. Of the 20 participants enrolled, 65% used the QR bracelet when seeking medical care. 55% found the bracelet useful, and 70% rated their experience as either "positive" or "very positive". Additionally, 80% recommended the bracelet for other patients undergoing cardiac procedures. The use of QR code bracelets for postoperative CHD patients has shown high levels of satisfaction from families and providers, potentially reducing medical errors and treatment delays.

The novel LESS (low-cost entrainment syringe system) O2 blender for use in modified bubble CPAP circuits: a clinical study of safety.

Background: Bubble continuous positive airway pressure (bCPAP) is used in resource-limited settings for children with respiratory distress. Low-cost modifications of bCPAP use 100% oxygen and may cause morbidity from oxygen toxicity. We sought to test a novel constructible low-cost entrainment syringe system (LESS) oxygen blender with low-cost modified bCPAP in a relevant clinical setting. Methods: We conducted a clinical trial evaluating safety of the LESS O2 blender among hospitalized children under five years old in rural Cambodia evaluating the rate of clinical failure within one hour of initiation of the LESS O2 blender and monitoring for any other blender-related complications. Findings: Thirty-two patients were included. The primary outcome (clinical failure) occurred in one patient (3.1%, 95% CI = 0.1-16.2%). Clinical failure was defined as intubation, death, transfer to another hospital, or two of the following: oxygen saturation <85% after 30 min of treatment; new signs of respiratory distress; or partial pressure of carbon dioxide ≥60 mmHg and pH <7.2 on a capillary blood gas. Secondary outcomes included average generated FiO2's with blender use, which were 59% and 52% when a 5 mm entrainment was used vs. a 10 mm entrainment port with 5-7 cm H2O of CPAP and 1-7 L/min (LPM) of flow; and adverse events including loss of CPAP bubbling (64% of all adverse events), frequency of repair or adjustment (44%), replacement (25%), and median time of respiratory support (44 h). Interpretation: Overall the LESS O2 blender was safe for clinical use. The design could be modified for improved performance including less repair needs and improved nasal interface, which requires modification for the blender to function more consistently.

Postoperative use and early discontinuation of intravenous lidocaine in spine patients.

PURPOSE: Our institution employs a multimodal approach to manage postoperative pain after spine surgery. It involves continuous intravenous (IV) lidocaine until the morning of postoperative day two. This study aimed to determine the rate and reasons for early discontinuation of IV lidocaine in our spine patients. METHODS: We conducted a retrospective chart review and included pediatric patients who underwent ≥ 3-level spine surgery and received postoperative IV lidocaine from November 2019 to September 2022. For each case, we recorded the side effects of IV lidocaine, adverse events, time to discontinuation, and discontinuation rate. Subsequently, we used the same methodology to generate an adult cohort for comparison. RESULTS: We included 52 pediatric (18M:34F) and 50 (21M:29F) adult patients. The pediatric cohort's mean age was 14 years (8-18), and BMI 23.9 kg/m2 (13.0-42.8). The adult cohort's mean age was 61 years (29-82), and BMI 28.8 kg/m2 (17.2-44.1). IV lidocaine was discontinued prematurely in 21/52 (40.4%) of the pediatric cases and 26/50 (52.0%) of the adult cases (RR = 0.78, p = 0.2428). The side effects noted in the pediatric cases vary, including numbness, visual disturbance, and obtundation, but no seizures. The most common adverse events were fever and motor dysfunction. CONCLUSION: The early discontinuation rate of IV lidocaine use after spine surgery for children in our institution does not differ significantly from that of adults. The nature of the side effects and the reasons for discontinuation between the groups were similar. Thus, the safety profile of IV lidocaine for pediatric spine patients is comparable to adults.

Diagnosing and Managing Linear Scleroderma in a Low-Resource Setting.

Background: Linear scleroderma is one of the five forms of scleroderma, but it is the most common form of localized scleroderma in childhood. If left untreated, it can lead to severe disfigurement and functional impairment. The typical appearance is a linear streak with cutaneous induration on the face or head in association with various ophthalmological and neurological signs and symptoms. Treatment typically includes corticosteroids and/or methotrexate with life-long monitoring for recurrence. Case Presentation. A 12-year-old girl presented to our clinic in northern rural Cambodia with a history of a linear streak on her forehead that was growing down her nasal bridge. She denied any tenderness or family history of rheumatic disease. Her history was significant for strabismus as a child. A visiting pediatric rheumatologist assisted us with the appropriate diagnosis and treatment plan. Conclusion: In our case report, we present a child with linear scleroderma who fortunately came to medical attention early and received appropriate treatment before the onset of complications. She was treated with systemic immunosuppression as well as topical steroids. After treatment, she had no further progression on her face and continued to follow up with us to monitor for disease activity. To summarize, linear scleroderma is an uncommon diagnosis for general pediatricians and should be recognized early to provide appropriate treatment and follow-up.

Reported Complications of Bubble Continuous Positive Airway Pressure Systems in Low-Resource Settings: An International Survey.

Lower respiratory tract infections (LRTIs) are the leading cause of death in young children globally. Most of the global burden of mortality from LRTIs occurs in low-resource settings (LRSs), where obtaining and maintaining respiratory support devices such as commercial bubble continuous positive airway pressure (bCPAP) can be prohibitive. Low-cost bCPAP devices exist, such as the homemade WHO-style bCPAP design, but the safety of this design has been called into question. Based on our team's experience with homemade bCPAP, the side effects of the high pressures described in recent studies are not commonly encountered. Therefore, we sought feedback via an international survey about various complications including pneumothorax from practitioners in LRSs who use two forms of homemade bCPAP. In our qualitative survey, we did not find a convincing pattern in the recall of complications between commercial bCPAP and homemade bCPAP with narrow- or wide-bore expiratory limb in neonates or older children.

Prolonged Elevations of Factor VIII and von Willebrand Factor Antigen After Multisystem Inflammatory Syndrome in Children.

Multisystem Inflammatory Syndrome in Children (MIS-C) is a late systemic inflammatory response to a recent mild or asymptomatic coronavirus disease of 2019 infection. The pathophysiology is incompletely understood but it often features significant coagulopathy along with cardiac and endothelial dysfunction. Endothelial inflammation has been primarily described in acute coronavirus disease of 2019 infection, with less characterization in MIS-C. Here we describe novel findings of nearly universal severe and prolonged factor VIII (FVIII) and von Willebrand factor antigen elevations in an institutional cohort of patients with MIS-C ages younger than or 21 years old (N=31). All patients had elevated acute phase reactants and D-dimer at presentation and met published criteria for MIS-C. FVIII was high at presentation in 97% of patients but continued to rise during the ensuing weeks of treatment to a mean 429%, peaking on median day 17 of illness as an outpatient. FVIII levels were >600% in multiple patients. von Willebrand factor antigen was measured less frequently but showed similar trends. These escalations occurred amidst resolving cardiac dysfunction and acute phase reactant normalization and despite patients receiving multimodal anti-inflammatory treatments and aspirin and enoxaparin thromboprophylaxis. No thrombotic events occurred. Endothelial dysfunction represented by very elevated FVIII levels may persist longer than other acute phase reactants may reflect.

Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience.

BACKGROUND: Timely trial start-up is a key determinant of trial success; however, delays during start-up are common and costly. Moreover, data on start-up metrics in pediatric clinical trials are sparse. To expedite trial start-up, the Trial Innovation Network piloted three novel mechanisms in the trial titled Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE), a multi-site, randomized, double-blind, placebo-controlled trial in the pediatric intensive care setting. METHODS: The three novel start-up mechanisms included: 1) competitive activation; 2) use of trial start-up experts, called site navigators; and 3) supplemental funds earned for achieving pre-determined milestones. After sites were activated, they received a web-based survey to report perceptions of the DOSE start-up process. In addition to perceptions, metrics analyzed included milestones met, time to start-up, and subsequent enrollment of subjects. RESULTS: Twenty sites were selected for participation, with 19 sites being fully activated. Across activated sites, the median (quartile 1, quartile 3) time from receipt of regulatory documents to site activation was 82 days (68, 113). Sites reported that of the three novel mechanisms, the most motivating factor for expeditious activation was additional funding available for achieving start-up milestones, followed by site navigator assistance and then competitive site activation. CONCLUSION: Study start-up is a critical time for the success of clinical trials, and innovative methods to minimize delays during start-up are needed. Milestone-based funds and site navigators were preferred mechanisms by sites participating in the DOSE study and may have contributed to the expeditious start-up timeline achieved. CLINICALTRIALS: gov #: NCT03938857.

A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits: Results from Design Feasibility Workshops.

Bubble CPAP is used in low-resource settings to support children with pneumonia. Low-cost modifications of bubble CPAP using 100% oxygen introduces the risk of hyperoxia. Our team developed a low-cost, readily constructible oxygen blender to lower the oxygen concentration. The next step in development was to test its construction among new users and ascertain three outcomes: construction time, outflow oxygen concentration, and an assessment of the user experience. Workshops were conducted in two countries. Instructions were delivered using a live demonstration, a video, and written instructions in the respective native language. Twelve volunteers participated. Average construction times were 24 minutes for the first attempt and 15 minutes for the second. The oxygen concentrations were 53-63% and 41-51% for the 5 and 10 mm entrainment ports, respectively. This novel, low-cost oxygen blender for bubble CPAP can be constructed among new users with reliable performance across devices.

Non-invasive Neurally Adjusted Ventilatory Assist (NAVA) in the pediatric ICU: assessing optimal Edi compliance.

BACKGROUND: Bronchiolitis patients are supported with non-invasive conventional modalities (HFNC, CPAP and BiPAP). Neurally Adjusted Ventilatory Assist (NAVA) is a newer mode which supports based on electrical activity of the diaphragm (Edi). It is unclear if non-invasive NAVA is used within optimal operational parameters. The study aim was to evaluate Edi compliance. METHODS: A retrospective chart review of bronchiolitis patients admitted to the PICU from January 2015 to January 2018 was undertaken. NAVA compliance within optimal parameters (defined as Edi peak values between 5-15 µV and Edi min < 1µV) was assessed as the primary outcome. Secondary outcomes included PICU length of stay (LOS), duration to minimal respiratory support (defined as 4 L/min or less on HFNC) and intubation rate in the conventional (non-NAVA) and non-invasive NAVA. RESULTS: Sixty-three patients with a mean age of 6.89 months with 30 on NAVA and 33 on non-NAVA support were analyzed. Compliance with optimal Edi peak and Edi min was 50.4% (±37.5%) and 33.8% (±26.2%) respectively. Regression models for PICU LOS with minimal respiratory support and for 1L/kg of HFNC showed adjusted R2= 0.96 and 0.92, respectively. The mean PICU stay for NAVA was 146.00 hrs. (±66.26) versus 69.58 hrs. (±57.69) for the non-NAVA group (p<0.001). Duration to minimal respiratory support was 125.40 hrs. (±54.90) for NAVA versus 58.03 hrs. (±58.97) for non-NAVA group (p<0.001). A higher intubation rate was found in the NAVA group (13.33% versus 3.03%, p=0.296). CONCLUSIONS: We found suboptimal compliance with operational parameters with non-invasive NAVA support. There was longer PICU LOS, time to minimal respiratory support in the NAVA compared to the non-NAVA support.

Implementation of a Critical Asthma Protocol in a Pediatric ICU.

BACKGROUND: Protocol-driven therapy has been successful in managing patients with asthma on pediatric wards, but there is wide variability in ICU-level management that is often provider-dependent. This study aimed to determine if a standardized protocol for critical asthma treatment could improve clinical outcomes. METHODS: A pre-intervention cohort consisting of subjects age 2-18 y, excluding patients with airway obstruction that was not felt to be due to asthma, who were admitted to the ICU for critical asthma. Demographics and data along with medication administration information were gathered using the hospital electronic medical record. A post-intervention cohort was obtained over 13 months in an identical manner. The primary end point was time on continuous albuterol. Subjects adhering to the protocol were examined as a subset. RESULTS: 71 post-intervention subjects were compared with a historical cohort of 52 pre-intervention subjects over a similar time frame. There were no significant differences in demographic characteristics. Median time on continuous albuterol (14.4 h vs 8.1 h, P = .14) and secondary end points of median ICU length of stay (LOS), hospital LOS, and time from discontinuing continuous albuterol to transfer out of ICU were not significantly reduced in the post-intervention cohort. Overall adherence to the clinical protocol through completion was 42%. When comparing the pre-intervention cohort with the protocol-adherent subjects, significant reductions were seen in time on continuous albuterol (14.4 h vs 3.0 h, P < .001), ICU LOS (38.7 h vs 21.0 h, P < .001), and hospital LOS (2.8 d vs 1.7 d, P = .005). CONCLUSIONS: Implementation of an asthma protocol in the pediatric ICU did not result in significant improvements in time on continuous albuterol or hospital and pediatric ICU LOS, likely due to low adherence to the protocol. However, in subjects who did adhere to the protocol there were significant reductions in the outcome measures.

Treatment of Hypothermic Cardiac Arrest in the Pediatric Drowning Victim, a Case Report, and Systematic Review.

OBJECTIVES: Drowning is the second leading cause of death in children. Extracorporeal membrane oxygenation (ECMO) has become the criterion standard therapy to resuscitate the hypothermic drowning victim in cardiac arrest. We present our own experience treating 5 children with hypothermic cardiac arrest in conjunction with a systematic review to analyze clinical features predictive of survival. METHODS: Our search resulted in 55 articles. Inclusion criteria were as follows: (1) younger than 18 years, (2) ECMO therapy, and (3) drowning. Ten articles met our inclusion criteria. We included studies using both central and peripheral ECMO and salt or fresh water submersions. We compared clinical features of survivors to nonsurvivors. RESULTS: A total of 29 patients from the 10 different studies met our criteria. Data analyzed included presenting cardiac rhythm, time to initiation of ECMO, submersion time, pH, potassium, lactate, duration of chest compressions, and survival. There was a significant increase in mortality for presenting rhythm of asystole and with hyperkalemia (P < 0.05). CONCLUSIONS: Extracorporeal membrane oxygenation is an important resuscitation tool for the hypothermic drowning victim. Hyperkalemia and presenting cardiac rhythm correlate with survival although they are not reasons to end resuscitation. More studies are needed to compare the outcomes in using ECMO for the hypothermic drowning victim.

Design and evaluation of a portable negative pressure hood with HEPA filtration to protect health care workers treating patients with transmissible respiratory infections.

BACKGROUND: To mitigate potential exposure of healthcare workers (HCWs) to SARS-CoV-2 via aerosol routes, we have developed a portable hood which not only creates a barrier between HCW and patient, but also utilizes negative pressure with filtration of aerosols by a high-efficiency particulate air filter. MATERIAL AND METHODS: The hood has iris-port openings for access to the patient, and an opening large enough for a patient's head and upper torso. The top of the hood is a high-efficiency particulate air filter connected to a blower to apply negative pressure. We determined the aerosol penetration from outside to inside in laboratory experiments. RESULTS: The penetration of particles from within the hood to the breathing zones of HCWs outside the hood was near 10-4 (0.01%) in the 200-400 nm size range, and near 10-3 (0.1%) for smaller particles. Penetration values for particles in the 500 nm-5 µm range were below 10-2 (1%). Fluorometric analysis of deposited fluorescein particles on the personal protective equipment of an HCW revealed that negative pressure reduces particle deposition both outside and inside the hood. CONCLUSIONS: We find that negative pressure hoods can be effective controls to mitigate aerosol exposure to HCWs, while simultaneously allowing access to patients.

Regional Planning for Extracorporeal Membrane Oxygenation Allocation During Coronavirus Disease 2019.

Health systems confronting the coronavirus disease 2019 (COVID-19) pandemic must plan for surges in ICU demand and equitably distribute resources to maximize benefit for critically ill patients and the public during periods of resource scarcity. For example, morbidity and mortality could be mitigated by a proactive regional plan for the triage of mechanical ventilators. Extracorporeal membrane oxygenation (ECMO), a resource-intensive and potentially life-saving modality in severe respiratory failure, has generally not been included in proactive disaster preparedness until recently. This paper explores underlying assumptions and triage principles that could guide the integration of ECMO resources into existing disaster planning. Drawing from a collaborative framework developed by one US metropolitan area with multiple adult and pediatric extracorporeal life support centers, this paper aims to inform decision-making around ECMO use during a pandemic such as COVID-19. It also addresses the ethical and practical aspects of not continuing to offer ECMO during a disaster.

3-Dimensional nature-based therapeutics in pediatric patients with total pancreatectomy and islet auto-transplant.

BACKGROUND: Virtual Reality (VR) has been increasingly employed as a therapeutic means to help patients reduce stress, anxiety, and pain. While it has been shown to be effective in multiple settings, there is still scant literature referencing its use in the pediatric intensive care unit (ICU) and none using VR longitudinally as a vehicle for mindful focus utilizing natural environments. OBJECTIVES: This proof of concept study aims to demonstrate that the use of 3-D Nature-Based Therapy (NBT) glasses will lead to a reduction in pain, nausea, and anxiety in children and adolescents undergoing Total Pancreatectomy Islet Auto-Transplant (TPIAT). METHODS: Six pediatric patients (8-18 yr.) scheduled to receive TPIAT were recruited over a one-year period. Patients rated their symptoms using various scoring methods, including a novel nature-based anxiety scale. If VR was used prior to a physical therapy session, this was also noted. Patients then utilized the Oculus ™ VR device and re-scored their symptoms. Interviews were performed at entry to study, post-ICU, and at hospital discharge. RESULTS: Four of six recruited patients utilized the VR device, three of whom completed pre- and post-use scores during 11 encounters, though many other encounters occurred without scoring. Of the two patients not utilizing the device, one chose to use other means of distraction and the other reported nausea and chose not to use device. Of the patients who utilized the device, there was a net decrease in symptom scores after use, including the use of the nature-based scale which mimicked both validated scales. On survey results, all patients who utilized the device found it to be "enjoyable" and "helpful", either "would" or "might use" it again, and "would recommend it to others" for use. CONCLUSIONS: In this proof of concept study, children in a critical care setting were able to utilize VR devices for NBT after extensive surgical procedures. Initial quantitative scoring systems suggest overall improvement in symptom management, and reactions by both patients and their parents were overall positive.

Use of virtual reality for pre-surgical planning in separation of conjoined twins: A case report.

We describe the use of virtual reality technology for surgical planning in the successful separation of thoracopagus conjoined twins. Three-dimensional models were created from computed tomography angiograms to simulate the patient's anatomy on a virtual stereoscopic display. Members of the surgical teams reviewed the anatomical models to localize an interatrial communication that allowed blood to flow between the two hearts. The surgical plan to close the 1-mm interatrial communication was significantly modified based on the pre-procedural spatial awareness of the anatomy presented in the virtual visualization. The virtual stereoscopic display was critical for the surgical team to successfully separate the twins and provides a useful case study for the use of virtual reality technology in surgical planning. Both twins survived the operation and were subsequently discharged from the hospital.

A model for overcoming challenges in academic pediatric medical device innovation.

Technological advancements in medical devices developed for adults far outpace the development of technologies designed for pediatric patients in the USA and other countries. This technology lag was previously reflected in a lack of pediatric-specific innovation within our academic institution. To address the institutional deficit of device innovation around pediatric patients, we formed unique partnerships both within our university and extending to the medical device industry, and developed novel programmatic approaches. The Pediatric Device Innovation Consortium (PDIC) bridges the medical device community and the University of Minnesota. Since 2014, the PDIC has supported 22 pediatric medical technology innovation projects, provided funds totaling more than $500,000, licensed two technologies, and advanced two technologies to patient use. Here, we describe the PDIC model and method, the PDIC approach to common challenges that arise in the development of small-market medical technologies at an academic institution, and iterations to our collaborative, multidisciplinary approach that have matured throughout our experience. The PDIC model continues to evolve to reflect the special needs of innovation for smaller markets and the unique role of clinician innovators. Our approach serves as a successful model for other institutions interested in creating support mechanisms for pediatric or small-market technology development.

Effects of an Ex Vivo Pediatric Extracorporeal Membrane Oxygenation Circuit on the Sequestration of Mycophenolate Mofetil, Tacrolimus, Hydromorphone, and Fentanyl.

OBJECTIVES: With the expanding use of extracorporeal membrane oxygenation (ECMO), understanding drug pharmacokinetics has become increasingly important, particularly in pediatric patients. This ex vivo study examines the effect of a pediatric Quadrox-iD ECMO circuit on the sequestration and binding of mycophenolate mofetil (MMF), tacrolimus, and hydromorphone hydrochloride, which have not been extensively studied to date in pediatric ECMO circuits. Fentanyl, which has been well studied, was used as a comparator. METHODS: ECMO circuits were set up using Quadrox-iD pediatric oxygenators and centrifugal pumps. The circuit was primed with whole blood and a reservoir was attached to represent a 5-kg patient. Fourteen French venous and 12 French arterial ECMO cannulas were inserted into the sealed reservoir. Temperature, pH, PO2, and PCO2 were monitored and corrected. MMF, tacrolimus, hydromorphone, and fentanyl were injected into the ECMO circuit. Serial blood samples were taken from a postoxygenator site at intervals over 12 hours, and levels were measured. RESULTS: Hydromorphone hydrochloride was not as significantly sequestered by the ex vivo pediatric ECMO circuit when compared with fentanyl. Both mycophenolic acid and tacrolimus serum concentrations were stable in the circuit over 12 hours. CONCLUSIONS: Hydromorphone may represent a useful medication for pain control for pediatric patients on ECMO due to its minimal sequestration. Mycophenolic acid and tacrolimus also did not show significant sequestration in the circuit, which was unexpected given their lipophilicity and protein-binding characteristics, but may provide insight into unexplored pharmacokinetics of particular medications in ECMO circuits.

Use of a modified bubble continuous positive airway pressure (bCPAP) device for children in respiratory distress in low- and middle-income countries: a safety study.

Background: While bubble continuous positive airway pressure (bCPAP) is commonly used in low- and middle-income countries (LMIC) to support neonates with respiratory distress, there are limited non-invasive support options for non-neonatal children. Aim: To demonstrate safety of a new device designed to support children during respiratory distress in LMIC. Methods: A paediatric bCPAP device was designed called SEAL-bCPAP (Simplified Ear-plug Adapted-bCPAP). SEAL-bCPAP is constructed from inexpensive, easily obtainable materials. The nasal prong interface was modified from previously described neonatal bCPAP set-ups using commercial ear-plug material to improve nasal seal. A prospective interventional study was conducted to evaluate safety in children with respiratory distress treated with SEAL-bCPAP. Patients aged 30 days to 5 years presenting to a hospital in northern Uganda from July 2015 to June 2016 were screened. Those with moderate-severe respiratory distress and/or hypoxia despite nasal cannula oxygen were eligible for study. Enrolled patients were supported with SEAL-bCPAP until respiratory improvement or death. Complications attributable to SEAL-bCPAP were recorded. Clinical outcomes were compared with historical control pre-trial data. Results: Eighty-three of 87 enrolled patients were included in the final analysis. No patients had significant SEAL-bCPAP complications. Five patients had mild complications which resolved (four with nasal irritation and one with abdominal distention). Trial patients had significant (p < 0.0001) improvement in their TAL score, respiratory rate and O2sat after 2 h of SEAL-bCPAP. Fifty-two of 64 patients (62.7%) with severe illness at Time1 did not have severe illness at Time2 (after 2 h of SEAL-bCPAP) (p < 0.0001). Unadjusted mortality rates were 12.2% (6/49) and 9.6% (8/83), respectively, for pre-trial (historical control) and trial patients (p = 0.64); the study was not powered to show efficacy. Conclusions: The SEAL-bCPAP device is safe for treatment of respiratory distress in non-neonatal children in LMIC. There is a trend toward decreased mortality that should be evaluated with adequately powered clinical trials.