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Effects of flow rate on transnasal pulmonary aerosol delivery of bronchodilators via high-flow nasal cannula for patients with COPD and asthma: protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Both in vitro and in vivo radiolabelled studies on nebulisation via high-flow nasal cannula showed that inhaled dose decreases as the administered gas flow increases. In our previous in vitro study, we investigated the effects of the ratio of gas flow to subject's peak inspiratory flow (GF:IF) on the aerosol deposition, which increased as the GF:IF decreased, with an optimal GF:IF between 0.1 and 0.5 producing a stable 'lung' deposition in both quiet and distressed breathing. Thus, we aim to validate our in vitro findings in subjects with reversible airflow limitations by assessing their response to inhaled bronchodilator. METHODS AND ANALYSIS:This is a single-centre, randomised controlled trial. Subjects with chronic obstructive pulmonary disease or asthma with positive response to 400?g albuterol via metered dose inhaler and valved holding chamber will be enrolled and consented. After a washout period (1-3 days), subjects will be randomly assigned to inhale albuterol with one of three gas flows: 50?L/min, GF:IF=1.0 and GF:IF=0.5. In each arm, subjects will inhale 2?mL saline, followed by escalating doubling doses (0.5, 1, 2 and 4?mg) of albuterol in a fill volume of 2?mL, delivered by a vibrating mesh nebuliser via heated nasal cannula set up at 37°C. An interval of 30?min between each dose of albuterol, with spirometry measured at baseline and after each inhalation. Titration will be terminated if forced expiratory volume in 1 s improvement is <5%, or adverse event is observed. ETHICS AND DISSEMINATION:This trial has been approved by the Ethic Committee of People's Liberation Army General Hospital, Beijing, China (no. S2018-200-01). The results will be disseminated through peer-reviewed journals, national and international conferences. TRIAL REGISTRATION NUMBER:NCT03739359; Pre-results.

SUBMITTER: Li J

PROVIDER: S-EPMC6597746 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Effects of flow rate on transnasal pulmonary aerosol delivery of bronchodilators via high-flow nasal cannula for patients with COPD and asthma: protocol for a randomised controlled trial.

Li Jie J Luo Jian J Chen Yibing Y Xie Lixing L Fink James B JB

BMJ open 20190624 6

<h4>Introduction</h4>Both in vitro and in vivo radiolabelled studies on nebulisation via high-flow nasal cannula showed that inhaled dose decreases as the administered gas flow increases. In our previous in vitro study, we investigated the effects of the ratio of gas flow to subject's peak inspiratory flow (GF:IF) on the aerosol deposition, which increased as the GF:IF decreased, with an optimal GF:IF between 0.1 and 0.5 producing a stable 'lung' deposition in both quiet and distressed breathing ...[more]

PMID: 31239304

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Project description:Background: High flow nasal cannula (HFNC) is commonly used as non-invasive respiratory support in critically ill children. There are limited data to inform consensus on optimal device parameters, determinants of successful patient response, and indications for escalation of support. Clinical scores, such as the respiratory rate-oxygenation (ROX) index, have been described as a means to predict HFNC non-response, but are limited to evaluating for escalations to invasive mechanical ventilation (MV). In the presence of apparent HFNC non-response, a clinician may choose to increase the HFNC flow rate to hypothetically prevent further respiratory deterioration, transition to an alternative non-invasive interface, or intubation for MV. To date, no models have been assessed to predict subsequent escalations of HFNC flow rates after HFNC initiation. Objective: To evaluate the abilities of tree-based machine learning algorithms to predict HFNC flow rate escalations. Methods: We performed a retrospective, cohort study assessing children admitted for acute respiratory failure under 24 months of age placed on HFNC in the Johns Hopkins Children's Center pediatric intensive care unit from January 2019 through January 2020. We excluded encounters with gaps in recorded clinical data, encounters in which MV treatment occurred prior to HFNC, and cases electively intubated in the operating room. The primary study outcome was discriminatory capacity of generated machine learning algorithms to predict HFNC flow rate escalations as compared to each other and ROX indices using area under the receiver operating characteristic (AUROC) analyses. In an exploratory fashion, model feature importance rankings were assessed by comparing Shapley values. Results: Our gradient boosting model with a time window of 8 h and lead time of 1 h before HFNC flow rate escalation achieved an AUROC with a 95% confidence interval of 0.810 ± 0.003. In comparison, the ROX index achieved an AUROC of 0.525 ± 0.000. Conclusion: In this single-center, retrospective cohort study assessing children under 24 months of age receiving HFNC for acute respiratory failure, tree-based machine learning models outperformed the ROX index in predicting subsequent flow rate escalations. Further validation studies are needed to ensure generalizability for bedside application.

Project description:IntroductionThe clinical benefit of high-flow nasal cannula (HFNC) on factors related to pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) patients remains unclear. This meta-analysis aimed at synthesizing the available evidence on the efficacy of HFNC on exercise capacity, lung function, and other factors related to pulmonary rehabilitation in COPD patients.MethodsElectronic databases (MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science) were searched for randomized trials comparing with conventional oxygen therapy (COT) or noninvasive ventilation (NIV). Primary outcomes were respiratory rate, FEV1, tidal volume, oxygen partial pressure, total score of St. George's respiratory questionnaire, 6-minute walk test, and exercise endurance time.ResultsTen trials met the criteria for inclusion. Combined data from six studies showed that HFNC showed a lower respiratory rate in COPD patients [mean difference -1.27 (95% CI: -1.65-(-0.89)]. Combined data from three studies showed a lower forced expiratory volume in one second (FEV1) in the group of HFNC. No difference in tidal volume was showed between the HFNC and control groups in COPD patients. No significant oxygen improvement between the HFNC groups and control groups. The total score of St. George's respiratory questionnaire was improved by the subgroup analysis of HFNC versus COT but no NIV. Two multicenter RCTs showed the six-minute walk test, and statistical results showed that the length of the six-minute walk capacity was increased after usage of HFNC compared to the control group [mean difference -8.65 (95% CI: -9.12-(-8.19)]. No increase of exercise capacity after usage of HFNC (mean difference -12.65).ConclusionIn the first meta-analysis of the area, the current evidence did not show so much positive effect on tidal volume or oxygen improvement in COPD patients. Length of the six-minute walk capacity was increased after using HFNC, while other pulmonary rehabilitation parameters, namely, the score of St. George's respiratory questionnaire and exercise capacity show no increase in the group of HFNC. The variance in the quality of the evidence included in this meta-analysis highlights the need for this evidence to be followed up with further high-quality and more randomized trials.

Project description:Rationale: The long-term effects of using a high-flow nasal cannula for chronic hypercapnic respiratory failure caused by chronic obstructive pulmonary disease remain unclear. Objectives: To assess whether long-term high-flow nasal cannula use reduces the number of exacerbations and improves other physiological parameters in patients with chronic hypercapnic respiratory failure caused by chronic obstructive pulmonary disease. Methods: We enrolled 104 participants (aged ⩾40 yr) with daytime hypercapnia (Global Initiative for Chronic Obstructive Lung Disease stages 2-4) receiving long-term oxygen therapy (⩾16 h/d for ⩾1 mo) and randomly assigned them to high-flow nasal cannula/long-term oxygen therapy and long-term oxygen therapy groups. The primary endpoint was the moderate or severe exacerbation rate. We compared changes from baseline in arterial blood gas values, peripheral oxygen saturation, pulmonary function, health-related quality-of-life scores, and the 6-minute-walk test. Measurements and Main Results: High-flow nasal cannula use significantly reduced the rate of moderate/severe exacerbations (unadjusted mean count 1.0 vs. 2.5, a ratio of the adjusted mean count between groups [95% confidence interval] of 2.85 [1.48-5.47]) and prolonged the duration without moderate or severe exacerbations. The median time to first moderate or severe exacerbation in the long-term oxygen therapy group was 25 (14.1-47.4) weeks; this was not reached in the high-flow nasal cannula/long-term oxygen therapy group. High-flow nasal cannula use significantly improved health-related quality of life scores, peripheral oxygen saturation, and specific pulmonary function parameters. No safety concerns were identified. Conclusions: A high-flow nasal cannula is a reasonable therapeutic option for patients with stable hypercapnic chronic obstructive pulmonary disease and a history of exacerbations. Clinical trial registered with www.umin/ac.jp (UMIN000028581) and www.clinicaltrials.gov (NCT03282019).

Dataset Information

Effects of flow rate on transnasal pulmonary aerosol delivery of bronchodilators via high-flow nasal cannula for patients with COPD and asthma: protocol for a randomised controlled trial.

Publications

Effects of flow rate on transnasal pulmonary aerosol delivery of bronchodilators via high-flow nasal cannula for patients with COPD and asthma: protocol for a randomised controlled trial.

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