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.

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.

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.

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.

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.

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.

Fulminant Mycoplasma Infection Requiring ECMO in a Previously Healthy Child: Case Report and Review.

Mycoplasma pneumoniae is a common cause of pneumonia and rarely requires hospitalization. We present a case of a 12-year-old girl who developed acute respiratory distress syndrome requiring extracorporeal membrane oxygenation (ECMO). Eight cases of Mycoplasma infection requiring ECMO reported to the Extracorporeal Life Support Organization and 16 cases reported in the literature are summarized with 72.7% survival cumulatively.

Continuous Antithrombin III Administration in Pediatric Veno-Arterial Extracorporeal Membrane Oxygenation.

The purpose of this retrospective case-control study is to determine the effect of continuous antithrombin III (ATIII) infusion on extracorporeal membrane oxygenation (ECMO) coagulation. All ECMO patients within the pediatric intensive care unit from January 2012 to July 2014 were included. Comparison was made between those who received continuous infusion ATIII through a standardized replacement protocol with historic controls receiving intermittent ATIII doses. Patients receiving the continuous infusion ATIII protocol spent more time in goal ACT range (71.9% vs 52.2%, p < 0.0001). Mean daily ATIII activity was also increased in study group (77.3% versus 68.6%, p = 0.04). No statistical differences in number of heparin dose changes per day (3 versus 3.22, p = 0.90) were present between the 2 groups. Only 28% of the historic controls receiving intermittent ATIII doses achieved normal ATIII activity as compared with 80% of study patients (p = 0.24). Maximum heparin dose was also lower in continuous infusion protocol group (p < 0.01). Compared with nonprotocolized intermittent dosing, the use of a continuous infusion ATIII protocol demonstrated increased time within goal ACT range at a lower heparin dose, no increase in hemostatic complications, and trends toward fewer heparin changes and lower blood product usage.

Gallbladder disease in patients undergoing laparoscopic adjustable gastric banding.

BACKGROUND: Patients undergoing weight loss surgery may have an increased incidence of subsequent gallbladder disease. Management options include treatment of symptomatic disease only, preoperative ultrasonography and concurrent cholecystectomy in presence of stones, routine concurrent cholecystectomy, and choleretic therapy postoperatively. Here we report our approach to patients undergoing laparoscopic adjustable gastric banding (LAGB) and subsequent outcomes. METHODS: A retrospective review of all consecutive patients undergoing LAGB at our institution was performed. Only symptomatic patients were preoperatively evaluated for cholelithiasis and underwent concurrent cholecystectomy. No choleretics were used postoperatively. Weight loss data were collected when patients returned for band adjustments. All band adjustments were patient-driven and performed under fluoroscopic guidance. RESULTS: Between November 2001 and July 2004, 324 patients underwent LAGB. Mean starting weight was 143.6 kg (range, 92.3 to 250.5 kg), and mean body mass index was 50.5 kg/m(2) (range, 35.6 to 80 kg/m(2)). Fifty-six patients had undergone previous cholecystectomy, and 7 other patients underwent concurrent cholecystectomy. Average follow-up was 12.5 months (range, 1.3 to 31 months). Absolute weight loss for all patients ranged from - 2.7 to 102.3 kg. Of the remaining patients, 3 underwent subsequent uneventful laparoscopic cholecystectomy for symptomatic cholelithiasis. No independent predictors for post-LAGB gallbladder disease were identified. CONCLUSION: Despite significant weight loss, few patients require cholecystectomy after LAGB. Routine preoperative ultrasonography, empiric cholecystectomy, and choleretic therapy are of questionable value in LAGB patients. Considering the magnitude of weight loss in our patients, empiric cholecystectomy for all bariatric procedures may merit further investigation.