Smartphone-based vs paper-based asthma action plans for adolescents.

BACKGROUND: Adolescents with asthma are at risk of poor outcomes and are traditionally difficult to reach. OBJECTIVE: To examine adolescents' use of and asthma outcomes associated with smartphone- vs paper-based asthma action plans (AAPs). METHODS: We conducted a 6-month randomized clinical trial with adolescents (12-17 years old) with persistent asthma. Participants used their respective smartphone or paper AAPs for medication instructions and peak flow or asthma symptoms logging. AAP use was measured electronically for smartphone users and via mail-in diaries for the paper group. Changes in Asthma Control Test (ACT) and self-efficacy scores were examined. RESULTS: Thirty-four adolescents participated in this study (median age, 15.4 years). Participants were mostly African American (62%) with state-issued insurance (71%). Adolescents in the smartphone group accessed the AAP a median of 12.17 times per week or 4.36 days per week but only recorded medications or symptoms and peak flow data in the electronic diary a median of 10 days per month during the 6-month period. Participants in the paper group recorded data a median of 23.5 days per month on their paper diaries. Overall, there were no changes in ACT and self-efficacy scores between groups. Adolescents with uncontrolled asthma (baseline ACT score ≤19) had an improvement in ACT for the smartphone group (before, 11; after, 20) ([P = .04) compared with no change in the paper group (before, 17; after, 17) (P = .64). Adolescent satisfaction with the application was high, with 100% stating they would recommend the smartphone AAP to a friend. CONCLUSION: Adolescents were frequent and highly satisfied users of the smartphone AAP with a subset of participants with uncontrolled asthma demonstrating possible clinical benefit. Findings suggest a need for larger-scale studies to determine the effectiveness of smartphone-based AAPs among high-risk patients with asthma. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02091869.

Predictors and outcome of low initial forced expiratory volume in 1 second measurement in children with cystic fibrosis.

OBJECTIVE: To identify the characteristics of children with cystic fibrosis with low initial forced expiratory volume in 1 second (FEV1) % predicted and to investigate their outcome. STUDY DESIGN: Patients were categorized into low or high initial FEV1 groups using cluster analysis. Comparisons of the demographic and clinical data were performed between the 2 groups. RESULTS: From 122 children, 21 clustered into the low and 101 into the high FEV1 group. The mean FEV1 was 69% ± 12% predicted for the low and 95% ± 12% predicted for the high FEV1 group (P < .001). The low FEV1 group had lower body mass index percentiles (P = .003), were hospitalized more frequently (P = .001), and had been on dornase alfa longer (P = .006). Low FEV1 group had more patients with positive cultures for Pseudomonas aeruginosa (P = .002) and Stenotrophomonas maltophilia (P < .001) and had more total number of cultures positive for mucoid P. aeruginosa (P = .009) and methicillin resistant Staphylococcus aureus + P. aeruginosa (P = .005). The low FEV1 group continued to have low FEV1 measurements, their FEV1 declined slower, required more hospitalizations per year (P = .01), and had more cultures for mucoid (P = .003) and nonmucoid P. aeruginosa (P = .02) ± methicillin resistant S. aureus (P = .002) in comparison with the high FEV1 group. Poor adherence was associated with lower initial FEV1 values in females, and early, rapid decline of FEV1 in males. CONCLUSIONS: Some children with cystic fibrosis may present with poor lung function early in life and continue to have subnormal lung function associated with reduced body mass index, more frequent hospitalization, and higher rates of infection. Such children may benefit from careful evaluation and close follow-up.

Delivery Efficiency of Albuterol Pressurized Metered Dose Inhaler Through Small Size Laryngeal Mask Airways in an Infant and Child Model.

BACKGROUND: Intraoperative bronchospasm in pediatric patients supported through laryngeal mask airways (LMAs) is commonly treated with pressurized metered-dose inhaler (pMDI) albuterol. The aim of the study was to evaluate delivery of pMDI albuterol through LMAs under different conditions in a model of infant/child supported with a ventilator. METHODS: We compared drug delivery efficiency of 4 actuations of albuterol pMDI (captured on a filter placed between the LMA and a test lung), drug deposition in the circuit (elbow) and in the LMA under different experimental conditions. Outcomes were expressed of percentage of nominal dose. We compared devices (valved holding chamber [VHC] and adapter), timing of administration (inspiration and expiration), tidal volumes (50 mL and 100 mL), mode of actuation (single and multiple), and LMA sizes (1, 1.5, and 2). Multiple regression analysis was used to evaluate the contribution of each to these components to the outcomes. P < .05 was considered statistically significant. RESULTS: Results are expressed as median (interquartile range) of pooled data. Drug delivery efficiency was 0% (0-1.1) and 6.3% (3.2-14.7) for adapter and VHC, respectively. Elbow deposition was 25.8% (19.2-63.3) and 2.9% (1.4-6.4) for adapter and VHC, respectively. LMA deposition was 2.6% (1.3-4.6) and 4.6% (2.9-6.1) for adapter and VHC, respectively. Multiple regression analysis showed that device, timing of actuation, and LMA size explained 33%, 17%, and 8% of the observed variation in delivery efficiency (R2 0.63), respectively. Multiple regression analysis showed that device and timing of actuation explained 52% and 16% of the observed variation, respectively (R2 0.70). Multiple regression analysis poorly explained factors associated with LMA deposition (R2 0.22). CONCLUSIONS: Using a VHC, actuating the pMDI during exhalation, and using a small LMA size increased drug delivery efficiency. The adapter was an inefficient add-on device for aerosol delivery with a pMDI through an LMA that caused significant circuit deposition.

Effect of Disinfection Method and Testing Methodology on the Performance of a Breath-Enhanced Jet Nebulizer.

National guidelines for cystic fibrosis recommend cleaning and disinfecting nebulizers after each use. We tested two groups of five reusable breath-enhanced nebulizers after 0, 5, 10, 15, 20, 30, 60, 90, 120, 150, and 180 sterilization (baby bottle sterilizer) or cleaning cycles. The nebulizers were operated for 7 min (6 L/min) after loading albuterol (2.5 mg/3 mL), and they were evaluated with and without breathing simulation after cleaning/sterilization (0-180 and 0-60 cycles, respectively). Over the course of 180 cleaning/sterilization cycles, the mean (SD) solution output was 1.33 mL (0.12 mL)/1.29 mL (0.08 mL); the nebulizer mass remaining in the nebulizer was 61.5% (5.2%)/63% (4%); sputtering time was 4.7 min (0.8 min)/4.8 s (0.6 min); inspiratory filter was 19% (3%)/18.5% (2.4%); expiratory filter was 6.7% (1.1%)/6.7% (0.8%); and difference in drug output calculated using the solution output and nebulizer mass was 6.8% (4%)/5.2% (2.9%). Thermal disinfection with a baby-bottle sterilizer did not alter the performance of a reusable breath-enhanced nebulizer. The nebulizer test performed without breathing simulation underestimated its performance. The calculation of the drug output based on the solution output resulted in its overestimation.

Albuterol Delivery During Invasive Mechanical Ventilation via In-Line Intrapulmonary Percussive Ventilation in a Pediatric Lung Model.

BACKGROUND: Patients receiving mechanical ventilation often require airway clearance and inhaled therapies. Intrapulmonary percussive ventilation (IPV) combines a high-frequency percussive ventilator with a jet nebulizer. Data on aerosol delivery efficiency of the device are scarce. We evaluated albuterol delivery efficiency while using an IPV in-line adapter under different conditions. METHODS: A pediatric lung model of invasive mechanical ventilation was used. The following independent variables were evaluated: lung condition (normal vs ARDS), ventilator mode (adaptive pressure ventilation vs pressure control), percent opening of adapter (0% vs 25% vs 50%), IPV driving pressure (25 psi vs 40 psi), IPV percussion setting (easy vs hard), and endotracheal tube (ETT) size (3.5 mm vs 5.5 mm). Albuterol delivery efficiency (mass captured in the filter expressed as percentage of loading dose) was selected as the dependent variable. Albuterol was captured on a filter at the tip of the ETT and quantified via spectrophotometry (276 nm). RESULTS: Albuterol delivery efficiency ranged from 0-2.89%. Median (interquartile range) and 95% CI around the median were 0.54% (0.37-1.00) and 0.50-0.63%, respectively. The coefficient of determination (R2) for the model including all variables was 0.363. The 2 main contributors were percent of adapter opening (R2 0.30) and IPV setting (R2 0.039). CONCLUSIONS: Albuterol delivery during invasive mechanical ventilation via in-line IPV in a pediatric lung model was inefficient. Alternative methods of delivering bronchodilators and other inhaled medications should be considered when IPV is used.

Home Spirometry in Children with Cystic Fibrosis.

We report the implementation of a pediatric home spirometry program at our institution. A respiratory therapist provided either a virtual or an in-person initiation visit that included a coached spirometry session. Families were instructed to perform daily uncoached spirometry sessions for 5 days. The program's quality assurance component was deemed not to be human research by the local IRB. In total, 52 subjects completed an initiation visit (34 with at least 3 additional uncoached spirometry sessions). The clinic spirometry and coached (same-day) sessions and uncoached (same-week) sessions were completed by 12 and 17 subjects, respectively. The median (99% CI) coefficients of variation for FEV1% of the uncoached maneuvers were 3.5% (2.9-5.9%). The median (IQR) FEV1% and FEV1 (mL) absolute differences between coached and uncoached home spirometry were -2% (-4 and +3%) and -25 mL (-93 and +93 mL), respectively. The median (IQR) absolute differences in FEV1% and FEV1 (mL) between coached or uncoached home spirometry and clinic spirometry were -6% (-10 and -2%) and -155 mL (-275 and -88 mL), and -4% (-10 and +5%), and -110 mL (-280 and +9 mL), respectively. Differences in absolute FEV1 (L) and FEV1% were found among different modalities of spirometry performed by people with cystic fibrosis. Understanding the variability of uncoached home spirometry and the differences among coached and uncoached home spirometry, hospital and coached home spirometry, and hospital and uncoached home spirometry for any given individual is crucial to effectively utilize this tool in clinical care.

Curriculum and Competency Evaluation in Respiratory Therapy Entry-to-Practice Programs.

BACKGROUND: Essential skills for respiratory therapists extend beyond the traditional scope of therapy. Respiratory therapists are expected to communicate effectively, deliver bedside education, and practice within interprofessional teams. Respiratory therapy entry-to-practice program accreditation standards require evaluation of student competence in communication and interprofessional practice. This study aimed to determine if entry into practice programs include curriculum and competency evaluation for oral communication, patient education, telehealth, and interprofessional activities. METHODS: The primary objective was to identify the curriculum and method of competency evaluation. The secondary objective was to compare degree programs. Directors of accredited respiratory therapy programs were invited to complete an anonymous survey with regard to degree program type, oral communication, patient education, learning strategies, telehealth, and interprofessional activities. Degree programs were classified as associate's of science 2 year, associate's of science < 2 year, or bachelor's of science. RESULTS: Of 370 invited programs, respondents in 136 programs (37%) completed the survey. Oral communication competence was evaluated by 82%. Patient education curriculum and competency evaluation were reported by 86% and 73%, respectively. Telehealth was rarely included or evaluated. Interprofessional activities were included by 74%, of whom 67% evaluated competency. Bachelor's of science programs were more likely to include a specific patient education course (P = .004), evaluate oral communication competency with unpaid preceptors (P = .036), and evaluate interprofessional competence through formal interprofessional programs (P = .005). Associate's degree 2-year programs used laboratory proficiency for patient education competency evaluation more often than other programs (P = .01). associate's of science < 2-year programs were more likely to include simulation experiences that involved motivational interviewing (P = .01). CONCLUSIONS: Differences exist among program types for curriculum and competency evaluation. Telehealth was rarely included or evaluated at any degree level. Programs should evaluate the need for enhanced patient education and telehealth instruction.

Implementation of a Respiratory Therapist-Driven Protocol for Spirometry and Asthma Education in a Pediatric Out-Patient Primary Care Setting.

BACKGROUND: Best practice guidelines for asthma management recommend education and spirometry at specific intervals. A written asthma action plan with education and spirometry is ordered at the discretion of physicians at our institution. An initial chart review revealed that asthma education and spirometry were not consistently ordered in the pediatric primary care clinics. This quality improvement study aimed to increase frequency of spirometry and asthma education in children with asthma seen in pediatric primary care through use of a respiratory therapist (RT)-driven protocol. METHODS: The protocol established that spirometry and education would be done annually for children ≥ 6 y of age with intermittent asthma and every 6 months for persistent asthma. RTs identified eligible subjects and placed the electronic medical record orders before the clinic visit. Physicians were invited to complete a questionnaire before and after protocol implementation to assess barriers and protocol satisfaction. RESULTS: Nine hundred and thirty-two children were included. Prior to protocol implementation, spirometry and education were completed in 64.9% and 62.6% of eligible children, respectively. Following protocol implementation, spirometry and education were significantly increased to 92.7% (P < .001) and 88.5% (P < .001), respectively. Physicians identified interruption in clinic flow as the primary barrier for ordering spirometry and were satisfied with the protocol. Physicians stated that communication with RT improved through use of this protocol. CONCLUSIONS: Implementation of an RT-driven protocol in an out-patient pediatric primary care setting significantly increased utilization of spirometry and education for children with asthma. RTs working in the pediatric out-patient primary care setting played a vital role in achieving best practices for asthma management. The implementation of the protocol enhanced interdisciplinary communication.

Aerosol therapy in adult critically ill patients: a consensus statement regarding aerosol administration strategies during various modes of respiratory support.

BACKGROUND: Clinical practice of aerosol delivery in conjunction with respiratory support devices for critically ill adult patients remains a topic of controversy due to the complexity of the clinical scenarios and limited clinical evidence. OBJECTIVES: To reach a consensus for guiding the clinical practice of aerosol delivery in patients receiving respiratory support (invasive and noninvasive) and identifying areas for future research. METHODS: A modified Delphi method was adopted to achieve a consensus on technical aspects of aerosol delivery for adult critically ill patients receiving various forms of respiratory support, including mechanical ventilation, noninvasive ventilation, and high-flow nasal cannula. A thorough search and review of the literature were conducted, and 17 international participants with considerable research involvement and publications on aerosol therapy, comprised a multi-professional panel that evaluated the evidence, reviewed, revised, and voted on recommendations to establish this consensus. RESULTS: We present a comprehensive document with 20 statements, reviewing the evidence, efficacy, and safety of delivering inhaled agents to adults needing respiratory support, and providing guidance for healthcare workers. Most recommendations were based on in-vitro or experimental studies (low-level evidence), emphasizing the need for randomized clinical trials. The panel reached a consensus after 3 rounds anonymous questionnaires and 2 online meetings. CONCLUSIONS: We offer a multinational expert consensus that provides guidance on the optimal aerosol delivery techniques for patients receiving respiratory support in various real-world clinical scenarios.

Discontinuation versus continuation of hypertonic saline or dornase alfa in modulator treated people with cystic fibrosis (SIMPLIFY): results from two parallel, multicentre, open-label, randomised, controlled, non-inferiority trials.

BACKGROUND: Reducing treatment burden is a priority for people with cystic fibrosis, whose health has benefited from using new modulators that substantially increase CFTR protein function. The SIMPLIFY study aimed to assess the effects of discontinuing nebulised hypertonic saline or dornase alfa in individuals using the CFTR modulator elexacaftor plus tezacaftor plus ivacaftor (ETI). METHODS: The SIMPLIFY study included two parallel, multicentre, open-label, randomised, controlled, non-inferiority trials at 80 participating clinics across the USA in the Cystic Fibrosis Therapeutics Development Network. We included individuals with cystic fibrosis aged 12-17 years with percent predicted FEV1 (ppFEV1) of 70% or more, or those aged 18 years or older with ppFEV1 of 60% or more, if they had been taking ETI and either (or both) mucoactive therapies (≥3% hypertonic saline or dornase alfa) for at least 90 days before screening. Participants on both hypertonic saline and dornase alfa were randomly assigned to one of the two trials, and those on a single therapy were assigned to the applicable trial. All participants were then randomly assigned 1:1 to continue or discontinue therapy for 6 weeks using permuted blocks of varying size, stratified by baseline ppFEV1 (week 0; ≥90% or <90%), single or concurrent use of hypertonic saline and dornase alfa, previous SIMPLIFY study participation (yes or no), and age (≥18 or <18 years). For participants randomly assigned to continue their therapy during a given trial, this therapy was instructed to be taken at least once daily according to each participant's pre-existing, clinically prescribed regimen. Hypertonic saline concentration was required to be at least 3%. The primary objective for each trial was to determine whether discontinuing was non-inferior to continuing, measured by the 6-week change in ppFEV1 in the per-protocol population. We established a non-inferiority margin of -3% for the difference between groups in the 6-week change in ppFEV1. Safety outcomes were analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT04378153. FINDINGS: From Aug 25, 2020, to May 25, 2022, a total of 672 unique participants were screened for eligibility for one or both trials, resulting in 847 total random assignments across both trials with 594 unique participants. 370 participants were randomly assigned in the hypertonic saline trial and 477 in the dornase alfa trial. Participants across both trials had an average ppFEV1 of 96·9%. Discontinuing treatment was non-inferior to continuing treatment with respect to the absolute 6-week change in ppFEV1 in both the hypertonic saline trial (-0·19% [95% CI -0·85 to 0·48] in the discontinuation group [n=133] vs 0·14% [-0·51 to 0·78] in the continuation group [n=140]; between-group difference -0·32% [-1·25 to 0·60]) and dornase alfa trial (0·18% [-0·38 to 0·74] in the discontinuation group [n=199] vs -0·16% [-0·73 to 0·41] in the continuation group [n=193]; between-group difference 0·35% [-0·45 to 1·14]), with consistent results in the intention-to-treat populations. In the hypertonic saline trial, 64 (35%) of 184 in the discontinuation group versus 44 (24%) of 186 participants in the continuation group and, in the dornase alfa trial, 89 (37%) of 240 in the discontinuation group versus 55 (23%) of 237 in the continuation group had at least one adverse event. INTERPRETATION: In individuals with cystic fibrosis on ETI with relatively well preserved pulmonary function, discontinuing daily hypertonic saline or dornase alfa for 6 weeks did not result in clinically meaningful differences in pulmonary function when compared with continuing treatment.

Survey of aerosol delivery techniques to spontaneously breathing tracheostomized children.

BACKGROUND: Therapeutic inhaled aerosols are often delivered to spontaneously breathing tracheostomized children. Although aerosol delivery can be affected by several factors, no recommendations for device/drug formulation choice are available. We hypothesized that practice modalities will vary among different institutions. METHODS: The respiratory care departments in institutions in the United States that train pediatric pulmonologists were surveyed regarding their practices of delivering aerosols to spontaneously breathing tracheostomized children. Characteristics of the institution; use of metered-dose inhalers (MDIs), nebulizers, and dry powder inhalers; use of a resuscitation bag to aid aerosol delivery (assisted); types of medication used; and factors affecting choice of delivery method were recorded. RESULTS: Of the invited institutions, 81% (38/47) participated, with 68% of them being freestanding children's hospitals. MDIs were used by 92% of the institutions surveyed, with similar use of unassisted (32%, with 83% of them using spacers), assisted (34%, with 100% of them using non-valved spacers), and both techniques (34%). Nebulizers were used by 97% of the institutions surveyed, with all using unassisted and 32% also using assisted technique. Tracheostomy aerosol mask was the most commonly used interface (89%). Assisted technique for either MDI or nebulizer was used by 68% of the institutions surveyed, with similar use of flow-inflating bag, self-inflating bag, and both devices. Types of inhaled medications utilized by surveyed institutions included aerosolized antibiotics (82%), corticosteroids (100%), short-acting ß agonists (100%), combination therapy (32%), and mucolytics (84%). Dry powders were not used. Patient cooperation was the most frequent and single most important factor influencing the choice of delivery method. CONCLUSIONS: A wide variation in practice of delivering aerosols to spontaneously breathing tracheostomized children was noted. In-vivo and in-vitro studies are needed to support clinical recommendations.

In Vitro Characterization of Aerosolized Albuterol Generated by a Jet Nebulizer and Delivered through a Heated Flow Nasal Cannula System.

Pediatric patients receiving respiratory support with heated flow nasal cannula (HFNC) systems frequently receive inhaled medications. Most available data have been obtained with vibrating mesh nebulizers that are expensive. Data are lacking regarding the feasibility of using less expensive devices such as continuous output jet nebulizers. The characteristics of the aerosols generated by jet nebulizers operated at different conditions (6 and 9 L/min) were studied alone and connected to a HFNC system and different size cannulas using a cascade impactor and spectrophotometry (276 nm). Aerosol characteristics changed while traveling through the HFNC system. Initial size selection occurred at the exit of the circuit (before connecting to the cannula) with all aerosol <5 µm. Nasal cannula size further selected aerosols and reduced drug delivery. The operating flow of the nebulizer did not affect the delivered mass but higher flows generated smaller particle size aerosols. The addition of supplemental flow significantly reduced the delivered mass. The measured aerosol characteristics would likely result in intrapulmonary deposition. The delivery of aerosolized albuterol generated by a continuous output nebulizer placed in the inlet of a HFNC system and connected to large or XXL cannulas is feasible.

Evaluating Drug Deposition Patterns from Turbuhaler® in Healthy and Diseased Lung Models of Preschool Children.

The efficacy of pediatric oral drug delivery using dry powder inhalers, such as Turbuhaler®, is dependent on the age and health of the test subjects. The available clinical data for these studies is scant and rarely provide correlations between the health condition and the regional lung deposition. In particular, the data and the correlations for pre-school children are minimal. Deposition simulations were performed using the newly developed Quasi-3D whole lung model to analyze the effect of health conditions on the regional lung deposition from the Turbuhaler® in 3-year-old children. The healthy lung model was created from CT scan data. Cystic-fibrosis models were created by uniformly constricting the airways to various degrees. The simulated drug deposition outcomes were validated against the available experimental data. The results show that, while the dose deposited in the lungs exhibits minor variations, the Peripheral:Central (P/C) ratio is strongly affected by both the health condition and the inflow variations. The above ratio is reduced by ~30% for the severely diseased case, compared to its healthy counterpart, for the same inhalation profile. This indicates that lower doses reach the peripheral lung, in pediatric cystic-fibrosis subjects, thus requiring a larger therapeutic dose.

Safe and Effective Use of Score-Based Continuous Albuterol Therapy in a Pathway for Treatment of Pediatric Asthma Exacerbation.

BACKGROUND: Standardized acute asthma management with score-based, respiratory therapist (RT)-driven pathways and protocols improves outcomes including decreased length of stay (LOS) and time on continuous albuterol therapy. Limited data are available for the safety of continuous albuterol used outside of pediatric ICU (PICU). We use a modified pediatric asthma score (PAS) for the asthma pathway at our institution. The safety and effectiveness of using PAS to initiate/stop continuous albuterol as part of a score-based, RT-driven asthma pathway were evaluated. METHODS: A retrospective review of children ≥ 2 y admitted for asthma exacerbation to the PICU and step-down unit who received continuous albuterol as part of the asthma pathway during 2017-2019 was completed. Demographic and clinical data were extracted including PAS, dose and duration of continuous albuterol, LOS, and complications. Outcomes of subjects admitted to the PICU and step-down unit were compared. RESULTS: Results are expressed as median (interquartile range). The study included 412 children (61% male, 59.9% Black, 92.7% non-Hispanic, 44.9% moderate persistent asthma) with age and weight of 6.4 (4.0-10.0) y and 24.8 (17.3-39.5) kg, respectively. Most children were admitted to step-down unit (71.1%). Initial albuterol dose, duration, and LOS were 15 (10-20) mg/h, 9.1 (5.7-16.0) h, and 1.4 (0.9-2.3) d, respectively. Respiratory support was required by 29% of subjects. Need to restart therapy (2.9%), transfer to PICU (1.7%), and intubation (0.5%) were infrequent. No pneumothoraces or deaths were reported. Emergency department visits (3.9%) or readmissions (0.7%) within 30 d of discharge were low. Subjects admitted to the PICU were sicker and required more therapies and respiratory support than those admitted to the step-down unit. CONCLUSIONS: Use of an RT-driven, score-based pathway for initiation and discontinuation of continuous albuterol for treatment of pediatric asthma exacerbation was safe and effective in the PICU and step-down unit.

In Vitro Comparison of Different Nebulizers Delivering 7% Hypertonic Saline.

BACKGROUND: Nebulized 7% hypertonic saline is used to treat patients with cystic fibrosis. Clinical trials supporting its use were conducted with breath-enhanced nebulizers (BEN). It is not uncommon for the specific nebulizer used in studies or prescribed by a physician to be unavailable to patients. The investigator compared the aerosol characteristics of hypertonic saline delivered by nebulizers of different operating principles. METHODS: A continuous-output nebulizer (CON), a breath-actuated (BAN) jet nebulizer, and 2 brands of BEN (Pari LC Plus and Sidestream Plus) were tested. Airway delivery and aerosol characteristics of nebulizers loaded with 7% hypertonic saline were determined with 3 breathing simulations (ie, infant, child, and adult breathing patterns) and cascade impaction, respectively. Solutes were analyzed with freezing point osmometry. RESULTS: Aerosols generated with the BEN and BAN had similar mass median aerodynamic diameters (3.43-3.67 µm), geometric standard deviations (2.12-2.34), percentage of particles < 5 µm (63.1-68.9%), and percentage of particles 1-3 µm (35.9-37%). The CON produced a larger aerosol than BEN and BAN. The 2 BENs had similar airway delivery values that were greater than those for both CON and BAN. CONCLUSIONS: Hypertonic saline aerosols generated with the BEN and BAN devices were similar, while that generated with the CON was different. Airway delivery was similar between the BEN devices, but higher than that observed with the BAN and CON devices.

Effects of Shake-Actuation Delay on Delivered Dose and Aerosol Characteristics of an Albuterol Suspension From a Pressurized Metered-Dose Inhaler.

BACKGROUND: Suspensions delivered via a pressurized metered-dose inhaler (pMDI) require shaking the canister before actuation to prevent drug sedimentation. We hypothesized that a shake-actuation delay of an albuterol hydrofluoroalkane (HFA) pMDI will increase and decrease delivered dose (DOSE) at the beginning and end of the canister's life, respectively, and that aerosol characteristics will remain unchanged with the delay. METHODS: Albuterol HFA pMDIs (90 µg/actuation, 200 doses) operated with and without a 30-s shake-actuation delay, and with and without a valved holding chamber (VHC), were studied. Ten puffs, with a 30-s interval between puffs and 5s of shaking, were actuated into a drug-recovery apparatus. Inhalers were studied throughout their entire life (from 200 doses to 0 remaining doses). Particle size analysis was performed with cascade impaction at the beginning, middle, and end of the canister's life. Albuterol mass was determined via spectrophotometry (276 nm). RESULTS: Mean (99% CI) delivered dose without shake-actuation delay was 100.4% (98.1-102.9%) of the nominal dose. Mean (99% CI) delivered dose with a VHC without a shake-actuation delay was 48.6% (46.2-50.9%) of the nominal dose. The shake-actuation delay increased and decreased delivered dose at the beginning and end of the canister's life, respectively, irrespective of VHC use. Decline in delivered dose began when 110-120 doses remained in the canister. Aerosol characteristics remained constant throughout the canister's life except for the amount of drug captured by the impactor for the pMDI with delay and the pMDI/VHC with delay. Adding a VHC to a pMDI operated with a delay increased fine-particle fraction and decreased the amount of drug captured by the impactor at the middle and at the end of the canister's life. CONCLUSIONS: A 30-s shake-actuation delay of an albuterol HFA pMDI increased and decreased delivered dose at the beginning and end of canister's life, respectively. Particle size characteristics at the end of the canister's life changed when the pMDI and pMDI/VHC were operated with a shake-actuation delay. Patients should re-shake the pMDI if it is not actuated immediately after shaking the canister.

Nutritional status between 5-10 years is associated with cystic fibrosis-related diabetes in adolescence.

BACKGROUND: Cystic fibrosis-related diabetes (CFRD) is a risk factor for adverse clinical outcomes including poor nutritional status, deterioration in lung functions, and increased mortality. The association between nutritional status between 5 and 10 years of age and later diagnosis of CFRD is not known. METHODS: A retrospective chart review was performed for our patients with CF between 10 and 18 years. Data was collected at age 5 and 10 years. Comparison made between patients with and without CFRD. RESULTS: Two groups were comparable for age and sex. At age 5, groups had no differences in weight, height, and body mass index. At age 10, the CFRD group had a lower body mass index (40.2 ± 24.7 vs. 61.5 ± 22.5 percentile, p = 0.02). Spirometry was similar between groups at 5 and 10 years. Patients with CFRD had lower growth velocity (5 ± 0.9 vs. 5.7 ± 0.9 cm/year, p = 0.03) and reduced weight gain rate (2.2 ± 0.9 vs. 3.2 ± 1.2 kg/year, p = 0.03) compared to patients without CFRD between 5 and 10 years. Patients with a weight gain less than 2.5 kg/year between 5 and 10 years were nine times more likely to develop CFRD in adolescence (Unadjusted Odds Ratio: 8.9; 95% CI:1.4, 47.2; p = 0.01). CONCLUSION: Patients who later developed CFRD had significantly lower weight gain rate and height growth between 5 and 10 years of age than those without diabetes. Close monitoring of nutritional status in before age 10 years may help identify CF patients at-risk of developing CFRD.

AARC Clinical Practice Guideline: Management of Pediatric Patients With Oxygen in the Acute Care Setting.

Oxygen therapy is one of the most important therapeutics offered in the clinical management of pediatric patients with cardiopulmonary disease. As the medical community seeks to ensure evidence-based management of clinical interventions, we conducted a systematic review with the goal of providing evidence-based clinical practice guidelines to answer questions surrounding the use of simple oxygen therapy to improve oxygenation, including a comparison of delivery devices, the efficacy of humidification, comparison of flows, and goals for use in children. Using a modification of the RAND/UCLA Appropriateness Method, we developed 4 recommendations to assist clinicians in the utilization of oxygen therapy in hospitalized children: (1) the use of an oxygen hood or tent in lieu of a low-flow oxygen device for consistent oxygen delivery is not recommended; (2) the use of high-flow nasal cannula therapy is safe and more effective than low-flow oxygen to treat infants with moderate to severe bronchiolitis; (3) the application of humidification with low-flow oxygen delivery is not recommended; (4) targeting [Formula: see text] 90-97% for infants and children with bronchiolitis is recommended; however, no specific target can be recommended for pediatric patients with respiratory diseases outside of bronchiolitis, and establishing a patient/disease oxygen therapy target upon admission is considered best practice.

Cystic Fibrosis Foundation Nebulizer and Compressor Accessibility Survey.

BACKGROUND: Although guidelines for inhaled therapies for individuals with cystic fibrosis (CF) are available, recommendations for compressors/nebulizers to optimize care are lacking. The CF Foundation (CFF) convened a multidisciplinary task force to assess the use, durability, accessibility, and cost burden of compressors/nebulizers. METHODS: Online surveys were developed and distributed to 287 CFF programs and adults with CF and parents of children with CF (adults with CF/parents). RESULTS: Health care providers from 38 states completed the survey (59% response rate). Respiratory therapists were mostly responsible to coordinate ordering nebulizers and compressors. Durable medical equipment companies were the most common source of acquisition of compressors (71.8%) and nebulizers (45.9%). A majority of health care providers did not feel the compressors were durable (51.1%) or that they could get enough nebulizers to their patients (69.2%). Barriers to procure compressors were reported. The survey was completed by 734 adults with CF/parents from 48 states. Most adults with CF/parents rated their compressor as durable (65.8%); however, 85.5% of respondents reported some user-experience problem(s). "Hoses popping off" and "increased nebulization time" were most commonly reported. Almost 20% of respondents did not have access to a compressor at some point in the previous year. Most adults with CF/parents did not change compressor filters per manufacturer's recommendation (40% never). Adults with CF/parents reported performing a median of 4 inhaled treatments per day. Median use of nebulizers was 6 months. Most adults with CF/parents thought they had enough nebulizers (53.7%). Individuals with CF doing more inhaled treatments reported more compressor malfunctions. The median out-of-pocket expense was $75-99 and $50-74 for compressors and nebulizers, respectively. CONCLUSIONS: Although the perceptions of health care providers and adults with CF/parents differed to a certain extent, the surveys uncovered several significant issues that may compromise quality of care. Improvement in access to devices and education are needed.

Albuterol delivery via intrapulmonary percussive ventilator and jet nebulizer in a pediatric ventilator model.

BACKGROUND: In-line administration of bronchodilators is widely used in pediatric patients receiving mechanical ventilation. We compared the amount of albuterol captured at the end of the endotracheal tube (ETT) with an intrapulmonary percussive ventilator (IPV) versus a Salter 8900 jet nebulizer placed in-line in a pediatric ventilator model, under various operating conditions. We hypothesized that the type of aerosol generator, tidal volume (V(T)), and position in the ventilator circuit would influence the albuterol delivery. METHODS: We connected a ventilator to a heated-wire ventilator circuit (heated to 37°C), to a cuffed 5.5-mm inner-diameter ETT, to a lung model, and ran the ventilator at pediatric ventilation settings: pressure-regulated volume-control mode, respiratory rate 20 breaths/min, PEEP 5 cm H(2)O, F(IO2) 0.4, inspiratory time 0.75 s, inspiratory rise time 0.15 s, and flow-triggering at 3 L/min. We collected aerosol with a filter at the distal end of the ETT (ie, between the ETT and the lung model). We tested 3 IPV units run on central O(2) at 50-PSI, with a drive pressure of 25 cm H(2)O, and 3 Salter 8900 units run on central O(2) at 6 L/min. We diluted 5 mg of albuterol in saline, and nebulized 3 mL with the jet nebulizer and 10 mL with the IPV. We studied V(T) (100 mL vs 200 mL), position in the circuit (at the humidifier vs at the Y-piece), and the IPV's "easy" and "hard" percussion settings. RESULTS: When positioned at the humidifier, the IPV delivered significantly less albuterol than the jet nebulizer (3.1-3.9-fold difference, P = .002). When the IPV was moved to the Y-piece, the albuterol delivery was similar to that of the jet nebulizer at either position. Neither increasing the V(T) nor increasing the IPV settings increased the albuterol delivery. CONCLUSIONS: The IPV delivered less albuterol than the jet nebulizer when placed at the humidifier. IPV was equivalent to jet nebulizer when placed at the Y-piece. Doubling the V(T) did not increase aerosol delivery.