BACKGROUND:Severe asthma exacerbation is treated with continuous albuterol. Little is known regarding the use of continuous albuterol during emergency medical transport. Our pediatric inter-facility transport service changed from using a large volume (LVN) to vibrating mesh (VMN) to administer continuous albuterol. The aim of this study was to evaluate the effect of the practice change on patient outcomes. We hypothesized that outcomes will be similar regardless of the device used. METHODS:A retrospective review of children with asthma treated with continuous albuterol during inter-facility transport from June 1, 2018, to June 30, 2023. Children were grouped by type of nebulizer (LVN or VMN) used during transport for continuous albuterol. Primary outcomes were hospital stay and duration of continuous aerosol therapy, compared between groups by median regression with weighting to account for differences between transport nebulizer groups. Secondary outcomes were use of respiratory support during continuous therapy, pediatric ICU, and intermediate care unit stay. RESULTS:Ninety-eight children were included in the analysis. Median age was 6 (3-9) years. Fifty-two (53%) and 46 (47%) children received continuous albuterol during transport with an LVN or VMN, respectively. Weighted differences between VMN and LVN in median hospital stay and duration of continuous albuterol were -0.72 days (P = .52) and -12.7 h (P = .052), respectively. High-flow nasal cannula was used more often during transport when the VMN was used (P < .001). Thirty-seven (80%) of children who utilized an LVN during transport were changed to a VMN upon admission. Their stay was longer than that of those who did not change to VMN. No adverse events were identified. CONCLUSIONS:Change in practice from an LVN to a VMN for administration of continuous albuterol during inter-facility transport was not associated with a change in stay or duration of continuous albuterol therapy.
BACKGROUND:Bubble humidification is often utilized with low-flow nasal cannulas despite a lack of evidence to support its use. The practice was discontinued in our children's hospital based on recommendations from the American Association for Respiratory Care clinical practice guideline for management of pediatric patients with oxygen in the acute care setting and other available literature. The aim of this study was to evaluate staff feedback post de-implementation of the practice. METHODS:Following staff and stakeholder communication, bubble humidification for low-flow oxygen therapy was discontinued in May 2024. Respiratory and nursing staff were invited to complete a post-de-implementation survey in August 2024. Domains included respondent demographics, clinical practice guideline familiarity, receipt of communication, agreement with the practice change, and patient concerns. Responses were collected electronically. RESULTS:Responses from 132 staff were analyzed. The majority were female (105, 79%), nurses (81, 61%), and had 5 years or less of work experience (49, 37%). Eighty-six (65%) reported familiarity with the guideline. Overall, 59 (45%) were indifferent to the practice change and 46 (35%) disagreed. More than half (75, 57%) were concerned about patients. Nurses were significantly younger (≤25 years, P = .052; 26-34 years, P = .005) and less experienced (0-5 years, P = .009) than respiratory therapists. There were no significant differences between disciplines for patient concern. Nasal irritation/dryness was the most common theme for the reason for disagreement and patient concern followed by epistaxis. CONCLUSIONS:Few nurses and respiratory therapists agreed with discontinuing bubble humidification despite clinical practice guideline recommendations, and many were concerned about patients. Prospective, randomized clinical trials for acute and chronic oxygen delivery are warranted.
RATIONALE:Change from baseline in FEV1 is a primary endpoint for many traditional clinical trials in cystic fibrosis (CF). Home spirometry holds promise as an endpoint for decentralized clinical trials, yet its cross sectional and longitudinal accuracy compared to office spirometry has never been evaluated prospectively in the research setting. OBJECTIVES:The primary objective was to estimate the accuracy of FEV1 measured by home compared to office spirometry using a repeated measures model. METHODS:Prospective, multicenter study comparing FEV1 measured by office vs. home spirometry in people with CF age ≥ 6. Over 3 months, participants performed office spirometry and home coached spirometry 3 times and home uncoached spirometry weekly. MEASUREMENTS AND MAIN RESULTS:115 participants were enrolled at 19 U.S. sites. Compared to office spirometry, estimated mean home coached percent predicted (pp) FEV1 at Visit 1 was 1.46% lower (95% CI -2.46. -0.37) and home uncoached slightly lower still (mean -3.31, 95% CI -4.54, -2.16). However, there was no significant difference in the estimated 3-month change in ppFEV1 between office and home coached or home uncoached spirometry: difference -0.22 (-1.54, 1.24) and 0.81 (-0.84, 2.57), respectively. CONCLUSIONS:Cross-sectionally, mean ppFEV1 by home spirometry is lower than office measurements, reinforcing that these measurements are not interchangeable. However, the change in ppFEV1 from baseline, which would be used to evaluate a treatment effect in a clinical trial, was not significantly different between home and office spirometry, suggesting that home spirometry may be a promising endpoint for decentralized trials in CF.
Rationale:Inhaled medications are the mainstay of chronic obstructive pulmonary disease (COPD) management. While consensus guidelines for pharmacological management in COPD are well-established, few guidelines exist regarding inhaled medication delivery systems. The COPD Foundation Nebulizer Consortium conducted a cross-sectional survey of patients with COPD and healthcare providers to understand their perceptions and utilization of nebulized medications. Methods:An online survey was conducted from February 7 through April 9, 2024. Patients completed a 42-question survey, including demographic information, tobacco use, symptoms severity, and the role of nebulizers in their treatment. Healthcare providers responded to a 17-question survey about their clinical experience with nebulized medications. Results:We analyzed responses from 347 patients and 39 healthcare providers. Among patients, 76.4% (265/347) were ≥65 years old, 72.0% (250/347) were female, 93.4% (324/347) were white, 90.5% (314/347) had a current or former smoking history, 77.6% (263/339) reported at least one exacerbation in the past year, and 70.8% (240/339) used some form of supplemental oxygen. Nebulizer use was reported by 84.1% (292/347) of patients. Among nebulizer users, 94.5% (276/292) used short-acting while only 22.3% (65/292) used long-acting nebulized medications. Patients reported that hand-held inhaler devices were easier to use (69.8%, 171/245), but nebulized therapy led to better symptom control (64.9%, 159/245) and had lower copays (67.8%, 166/245). Among prescribers surveyed, most (82.1%, 32/39) believed nebulizers were preferable for patients experiencing exacerbations. Impediments to wider use of nebulizers included difficulties with insurance coverage (69.2%, 27/39), cost (53.8%, 21/39), and lack of combination nebulized drugs (46.2%, 18/39). Two-thirds of providers thought that nebulizers were underused. Conclusion:We demonstrate that while patients and providers both perceive nebulizers as preferred in clinical management of COPD, there is discordance between patient and provider perception of nebulizer use on the basis of cost and feasibility of use.
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.
INTRODUCTION Serial lung function measurement is a critical aspect of monitoring lung health in pulmonary diseases. Traditionally, spirometry was only performed in-person but after the COVID pandemic the use of remote monitoring has increased and become more available. There are several low cost (<$200) devices available in the market that measure forced expiratory volume in 1 second (FEV1) and peak expiratory flow (PEF). Few also measure forced vital capacity (FVC). However, their accuracy and reproducibility are not well reported. METHODS Six new units of Somnol (pressure sensor), Microlife (turbine), and Spirolink (pressure sensor) and 10 new units of ZEPHYRx (turbine) home spirometers were evaluated under ambient temperature, pressure, saturated (ATPS) conditions. A calibrated Hans Rudolph series 1120 flow/volume simulator was used to generate standardized ATS waveforms #3 (FEV1=1,202 L & PEF=287.6 L/min), #7 (FEV1=1,052 L & PEF=150.4 L/min), and #17 (FEV1=2.81 L & PEF=350.5 L/min), for all devices and additionally #26 (FVC=5.27 L, FEV1=4.315 L & PEF=695.7 L/min) for ZEPHYRx. Each unit was tested in triplicate with each waveform. Percent variation from reference waveform (accuracy) and coefficient of variation (CV) of repeated measures (repeatability) were calculated. Outcomes were compared among the different devices using Kruskal Wallis followed by Dunn's when needed. A p value < 0.05 was considered statistically significant. RESULTS Summary data are presented in Table 1. Variation from waveform for FEV1 was as follows: waveform #3: Somnol > Spirolink and Microlife, and ZEPHYRx > Microlife; waveform #7 Somnol > ZEPHYRx, and Spirolink > ZEPHYRx; waveform #17 Somnol > Spirolink and Microlife, and Spirolink and Microlife > ZEPHYRx. Variation from waveform for PEF was as follows: waveform #3 Spirolink > Somnol and Microlife, and Somnol > Microlife; waveform #7 Microlife > Somnol, and Spirolink > Microlife; waveform 17 Spirolink > Somnol and Microlife. While most devices had a low CV (< 3%) for PEF, the CV for FEV1 was larger ranging from 0.4 to 26.6%. CONCLUSIONS Low-cost spirometers showed good repeatability and accuracy for PEF measurements. However, accuracy and repeatability of FEV1 measurements varied significantly among test tested devices.
Asthma is a heterogeneous disease characterized by variable, reversible airway obstruction and hyper-responsive airways. In the United States, it is estimated nearly 25 million adults and children have asthma with over 4 million being children. Despite national and global asthma management guidelines, 44% of children report poor asthma control, resulting in higher health care utilization, greater number of missed work/school days, and poorer quality of life, all contributing to the United States' economic burden of more than $80 billion annually. The landscape of health care is transforming rapidly as technology advancements accelerate integration of digital health technology into patient care and management. Digital health technology uses computing platforms, connectivity, software, artificial intelligence, machine learning, and sensors to manage illnesses and health risks and promote wellness with a strong emphasis around personalized health care. This includes wearable devices, mobile health, telehealth, health information technology, remote monitoring, and telemedicine. A literature search on electronic monitoring for pediatric asthma was done that also included wearable devices, smart inhaler, digihaler, smart spacer, smart nebulizer, adherence monitoring, home spirometry, and symptom monitoring. The aim of this article is to review literature on how digital health technology can impact asthma care by identifying and educating about environmental triggers, prompting earlier recognition of asthma symptoms, and improving medication adherence and inhaler device technique.
Background Adolescents with asthma are vulnerable to poor asthma outcomes due to inadequate self-management skills and nonadherence to medications. Mobile health (mHealth) apps have shown promise in improving asthma control, medication adherence, and self-efficacy. However, existing mHealth asthma apps lack personalization and real-time feedback and are not tailored for at-risk adolescents. Objective This study aimed to design, develop, and test a smartphone-based mHealth Asthma Action Plan for adolescents, called Pulmonary Education and Knowledge Mobile Asthma Action Plan (PEAK-mAAP), in preparation for a large-scale randomized controlled trial. Methods We employed user-centered design principles to develop our app, leveraging our previous work and following guidelines from the National Heart, Lung, and Blood Institute. The app consists of a patient-facing mobile app and a provider-facing portal. A convenience sample of 13 adolescents (aged 12‐20 years) was recruited from the Arkansas Children’s Research Institute database or direct health care provider referrals. Participants underwent a task-based usability assessment followed by the System Usability Scale assessment to measure user satisfaction, interface effectiveness, and overall system usability. Results PEAK-mAAP integrates 7 core modules supporting personalized asthma self-management, symptom monitoring, medication tracking, and real-time feedback. The mean System Usability Scale score was 83/100 (SD 5.54), indicating high user satisfaction and system usability. Notably, older adolescents (>17 years) reported higher usability scores (87.5) than younger users (77.5), suggesting potential age-related differences in app navigation and engagement. Conclusions The results demonstrate that PEAK-mAAP is a feasible and user-friendly mHealth intervention for adolescent asthma self-management. While the high usability score reflects a positive user experience, some participants encountered initial usability challenges, highlighting the need for minor refinements and user training materials. The integration of personalized self-management tools and real-time feedback distinguishes PEAK-mAAP from existing asthma apps, addressing key barriers to adherence and engagement. Moving forward, an ongoing randomized controlled trial will assess its clinical effectiveness, long-term engagement, and impact on asthma outcomes, providing further insights into its potential as a scalable solution for adolescent asthma care.
BACKGROUND:Lung disease is a major cause of morbidity and mortality in children with sickle cell disease (SCD), a condition that is more common in individuals of African American descent. Spirometry is utilized in monitoring lung health. Recently, the American Thoracic Society recommended the use of race-neutral predictive equations. We aimed to evaluate how the use of race-neutral equations may affect spirometry results and interpretation in children with SCD. METHODS:This retrospective study included children aged 5-21 years with SCD followed at Arkansas Children's Hospital (01/01/2000-06/30/2023) who had completed at least one spirometry. Percent predictive (pp) and z-score values were calculated using race-adjusted and race-neutral predictive equations. Absolute and relative differences were calculated. Percent of subjects with forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC) with z-score <-1.645 and pp < 80%, and FEV1/FVC z-score < -1.645 were compared. Severity of impairment based on z-score was compared. RESULTS:One hundred children completed 460 spirometries. Transitioning from race-adjusted to race-neutral equations resulted in [mean (SD)]: a decrease in ppFEV1 [-9.497% (2.8344)], FEV1 z-score [-0.723 (0.2286)], ppFVC [-10.08% (3.3440)], FVC z-score [-0.750 (0.2757)], FEV1/FVC z-score [-0.057 (0.05461)], and an increase in ppFEV1/FVC [0.2785 (0.3921)]. Transitioning from race-adjusted to race-neutral equations resulted in an increase of impairment for FVC and FEV1 and a threefold increase in subjects with abnormal values. CONCLUSIONS:Adoption of race-neutral reference equations resulted in a decrease in FEV1 and FVC values (z-scores and percent predicted) and an increase in severity of impairment.
BACKGROUND:The Global Lung Initiative (GLI) recently developed a race-neutral reference equation in 2022 (GLI-2022); however, the implications of its use in children with asthma, especially Latino children, have not been extensively studied. OBJECTIVE:To assess the difference in spirometry results, asthma severity, and airway obstruction classification for African American (AA), Latino, and White children with asthma after implementing GLI-2022. METHODS:This retrospective cross-sectional study evaluated the first spirometry performed by children with asthma aged 5 to 17 years between January 1, 2018, and December 31, 2023. z-Scores and percent-predicted (pp) values for forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and FEV1/FVC were calculated using GLI-2022 and race-adjusted GLI-2012 equations. RESULTS:A total of 7138 children (3543 AA, 2795 White, and 800 Latino) were included (median age = 10.3 years). FEV1 z-score median difference was -0.872, -0.360, and +0.267 in AA, Latino, and White children, respectively (P < .0001) after implementing GLI-2022. FVC z-scores, ppFEV1, and ppFVC values demonstrated similar patterns. Adopting GLI-2022 worsened asthma severity (based on ppFEV1) and degree of airway obstruction (based on FEV1 z-score) classifications in AA children, improved them in White children, and did not affect Latino children. CONCLUSION:Implementing GLI-2022 affected asthma severity and airway obstruction classifications and resulted in a lower FVC and FEV1 in AA and Latino children and greater values in White children. Using GLI-2022 may uncover more cases of underdiagnosed asthma in AA and Latino children, which may contribute to alleviating disparate asthma outcomes.
Asthma is a chronic respiratory condition affecting 6.5% of the pediatric population in the United States. Inhaled medications are the mainstay of treatment of asthma. Delivering inhaled medications to children with asthma has several challenges. Personalized device selection and education are paramount for successful asthma treatment. The complexity of drug delivery in pediatric asthma is potentiated by the anatomical, physiological, and behavioral differences present in children. In addition, aerosols are given for preventive and for rescue reasons. The latter might also occur in children receiving respiratory support. This article reviews patient- and device-related factors affecting inhaled drug delivery and deposition. It also provides a framework to understand variations of drug delivery that occur during transition between different respiratory support devices. This review also discusses clinical trial data comparing different devices. Finally, guidance on how to choose the right delivery device for each patient is provided.
BackgroundMobile health (mHealth) technology has the ability to integrate personalized health management into patients’ daily routines. In prior investigations of mHealth apps for asthma, patient satisfaction and acceptability have been high. However, rigorous randomized controlled trials (RCTs) examining their effectiveness are sparse; the majority of mHealth asthma apps lack personalization and real-time feedback and fail to include at-risk pediatric populations, and many previous studies are not randomized. ObjectiveThis full-scale RCT will examine the effectiveness of the Pulmonary Education and Asthma Knowledge Mobile Asthma Action Plan (PEAKmAAP), an interactive mHealth asthma action plan (mAAP) smartphone app, among adolescents compared to enhanced usual care (eUC). The study has 3 aims: (1) examine the effectiveness of PEAKmAAP in reducing asthma morbidity, as measured by the Asthma Control Test (ACT) score, health care use, medication use, and lung function; (2) examine the effectiveness of PEAKmAAP in asthma self-efficacy and medication adherence; and (3) examine the impact of sharing PEAKmAAP-generated data with the primary care provider (PCP) for a subset of enrolled subjects. We hypothesize that the PEAKmAAP groups will experience reduced asthma morbidity compared to the eUC group. Furthermore, we hypothesize that PCP data sharing is expected to enhance PCP prescribing patterns and that more adolescents in the Pulmonary Education and Asthma Knowledge Mobile Asthma Action Plan with data sharing (PEAKmAAP-DS) group will have sustained controlled at follow-up visits compared to PEAKmAAP alone or eUC. MethodsUsing a 3-arm RCT lasting 12 months, we will assess the effectiveness of PEAKmAAP in reducing morbidity among 432 adolescents (age 12-20 years). The study population includes adolescents with uncontrolled symptoms who receive primary care at the Arkansas Children’s Hospital (ACH) or asthma care at ACH specialty clinics. At baseline, participants are randomly assigned to 1 of 3 groups: (1) PEAKmAAP group, (2) PEAKmAAP-DS group, and (3) eUC group using a smartphone app with daily non–asthma-related notifications. Study procedures will include baseline, 3-month, and 12-month in-person visits and telephone visits at 6 and 9 months. In-person visits will measure the ACT score, lung function, and self-efficacy; telephone visits will measure the ACT score. Participants will complete monthly online surveys to assess health care use and medication use. ResultsRecruitment and data collection began in March 2019, and data collection concluded in May 2024. Full data analysis began in December 2024. ConclusionsThis RCT aims to examine the effectiveness of a mAAP with real-time feedback and PCP data sharing. The study addresses existing gaps in knowledge regarding implementation of a mAAP for high-risk adolescents and has the potential to serve as a model for other populations at high risk for asthma. Trial RegistrationClinicalTrials.gov NCT03842033; https://clinicaltrials.gov/study/NCT03842033 International Registered Report Identifier (IRRID)DERR1-10.2196/69903
As the integration of informatics into clinical research reshapes the landscape of decentralized studies, optimizing participant experience remains a key challenge. Although prior research has established foundations for decentralized study design, a more comprehensive understanding of participant perspectives is essential to ensure remote methods for data collection meet participant needs. This study contributes to a growing literature in participant-centered decentralized studies through an analysis of OUTREACH, a 3-month home spirometry study among individuals with cystic fibrosis. Through a qualitative analysis of 46 participant exit interviews, we identified three overarching categories that influenced participant experience: motivators, technological infrastructure, and human coordination. Our findings emphasize the value of reliable technology and comprehensive interpersonal support systems. These findings shed light upon the importance of sociotechnical elements for optimizing participant experience, which may enhance the quality of clinical study data through meaningful participant engagement.