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.

Development of an Approach to Assessing Pediatric Fellows' Transport Medical Control Skills.

BACKGROUND AND OBJECTIVE: Pediatric interfacility transport teams facilitate access to subspecialty care, and physicians often guide management remotely as transport medical control (TMC). Pediatric subspecialty fellows frequently perform TMC duties, but tools assessing competency are lacking. Our objective was to develop content validity for the items required to assess pediatric subspecialty fellows' TMC skills. METHODS: We conducted a modified Delphi process among transport and fellow education experts in pediatric critical care medicine, pediatric emergency medicine, neonatal-perinatal medicine, and pediatric hospital medicine. The study team generated an initial list of items on the basis of a literature review and personal experience. A modified Delphi panel of transport experts was recruited to participate in 3 rounds of anonymous, online voting on the importance of the items using a 3-point Likert scale (marginal, important, essential). We defined consensus for inclusion as ≥80% agreement that an item was important/essential and consensus for exclusion as ≥80% agreement that an item was marginal. RESULTS: The study team of 20 faculty drafted an initial list of items. Ten additional experts in each subspecialty served on the modified Delphi panel. Thirty-six items met the criteria for inclusion, with widespread agreement across subspecialties. Only 1 item, "discussed bed availability," met the criteria for inclusion among some subspecialties but not others. The study team consolidated the final list into 26 items for ease of use. CONCLUSIONS: Through a consensus-based process among transport experts, we generated content validity for the items required to assess pediatric subspecialty fellows' TMC skills.

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.

The Pediatric Bougie for the First Tracheal Intubation Attempt in Critically Ill Children.

STUDY OBJECTIVE: Bougie use during emergency tracheal intubation has not been well studied in children. METHODS: This was a 10-year observational study of pediatric intubations (<18 years of age) in the emergency department (ED) of an academic institution. Bougie training and use are standard in our ED, including for emergency medicine residents. Study data were collected by a combination of charts and video reviews. We compare first-attempt intubation success and procedural complications between pediatric patients with and without bougie use during tracheal intubation in the ED. In addition, we evaluate the independent association of bougie use with first-attempt intubation success using multivariable logistic regression. RESULTS: We collected data on intubation success and bougie use for 195 pediatric patients over more than 10 years. On the first tracheal intubation attempt, a pediatric bougie was used in 126 patients (65%). Median patient age was 5 years (interquartile range 1.7 to 9) in the bougie group and 1.7 years (interquartile range 0.2 to 5) in the no bougie group. Intubation was successful on the first attempt in 72% of intubations with a bougie versus 78% without a bougie (absolute difference -6%, 95% confidence interval [CI] -19 to 6%); the adjusted odds of first-attempt success with a bougie were 0.54 (95% CI 0.24 to 1.19). A procedural complication occurred for 38% of patients in the bougie group versus 51% in the no bougie group (-13%, 95% CI -27% to 2%). Two neonates, one in each group, experienced a potential injury to the airway or lower respiratory tract. CONCLUSION: In an academic ED where the bougie is commonly used, bougie use in children was not associated with procedural success or complications. Our study suggests that a randomized clinical trial is needed to determine the effect of bougie use during emergency pediatric intubation.

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.

Transport Medical Control Education for Pediatric Critical Care Fellows: A National Needs Assessment Study.

OBJECTIVES: Characterize transport medical control education in Pediatric Critical Care Medicine fellowship. DESIGN: Cross-sectional survey study. SETTING: Pediatric Critical Care Medicine fellowship programs in the United States. SUBJECTS: Pediatric Critical Care Medicine fellowship program directors. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We achieved a 74% (53/72) response rate. A majority of programs (85%) require fellows to serve as transport medical control, usually while carrying out other clinical responsibilities and sometimes without supervision. Fellows at most programs (80%) also accompany the transport team on patient retrievals. Most respondents (72%) reported formalized transport medical control teaching, primarily in a didactic format (76%). Few programs (25%) use a standardized assessment tool. Transport medical control was identified as requiring all six Accreditation Council for Graduate Medical Education competencies, with emphasis on professionalism and interpersonal and communication skills. CONCLUSIONS: Transport medical control responsibilities are common for Pediatric Critical Care Medicine fellows, but training is inconsistent, assessment is not standardized, and supervision may be lacking. Fellow performance in transport medical control may help inform assessment in multiple domains of competencies. Further study is needed to identify effective methods for transport medical control education.

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.

Pediatric Critical Care in Resource-Limited Settings-Overview and Lessons Learned.

Pediatric critical care is an important component of reducing morbidity and mortality globally. Currently, pediatric critical care in low middle-income countries (LMICs) remains in its infancy in most hospitals. The majority of hospitals lack designated intensive care units, healthcare staff trained to care for critically ill children, adequate numbers of staff, and rapid access to necessary medications, supplies and equipment. In addition, most LMICs lack pediatric critical care training programs for healthcare providers or certification procedures to accredit healthcare providers working in their pediatric intensive care units (PICU) and high dependency areas. PICU can improve the quality of pediatric care in general and, if properly organized, can effectively treat the severe complications of high burden diseases, such as diarrhea, severe malaria, and respiratory distress using low-cost interventions. Setting up a PICU in a LMIC setting requires planning, specific resources, and most importantly investment in the nursing and permanent medical staff. A thoughtful approach to developing pediatric critical care services in LMICs starts with fundamental building blocks: training healthcare professionals in skills and knowledge, selecting resource appropriate effective equipment, and having supportive leadership to provide an enabling environment for appropriate care. If these fundamentals can be built on in a sustainable manner, an appropriate critical care service will be established with the potential to significantly decrease pediatric morbidity and mortality in the context of public health goals as we reach toward the sustainable development goals.

Diagnosis of Systemic Capillary Leak Syndrome in a Young Child Treated with Intravenous Immunoglobulin in the Acute Phase.

Systemic capillary leak syndrome (SCLS) is a potentially life-threatening disorder characterized by distributive shock, hypoalbuminemia, and hemoconcentration. It is exceedingly rare in children with less than 20 cases reported to date. The underlying cause for this syndrome remains largely unknown and acute treatment has remained mainly supportive. Prophylaxis with intravenous immunoglobulin (IVIG) has been shown to successfully prevent further episodes in both adults and children. We present a case of a 2-year-old previously healthy male admitted to the pediatric intensive care unit with a clinical course consistent with SCLS. His shock was refractory to aggressive fluid and vasopressor support. Reversal of SCLS with IVIG given in the acute phase had been described in three adult subjects, and for this reason, the decision was made to administer IVIG. Within an hour of administration, hemodynamics stabilized and vasopressor support could be weaned. He has had no further episodes on prophylactic infusions of IVIG. Although the exact mechanism of IVIG in SCLS is unknown, it has proven to be an effective and safe prophylactic therapy, and in our patient, it drastically reversed the acute capillary leak. We suggest that IVIG should be considered as acute therapy in pediatric patients with refractory shock and a clinical course suggestive of SCLS.