scholarly journals Lung Function Variability in Children and Adolescents With and Without Asthma (LUV Study): Protocol for a Prospective, Nonrandomized, Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Eirini-Sofia Frima ◽  
Ilias Theodorakopoulos ◽  
Dimos Gidaris ◽  
Nikolaos Karantaglis ◽  
Grigorios Chatziparasidis ◽  
...  

BACKGROUND Variability analysis of peak expiratory flow (PEF) and forced expiratory volume at 1 second (FEV1) has been used in research to predict exacerbations in adults with asthma. However, there is a paucity of data regarding PEF and FEV1 variability in healthy children and adolescents and those with asthma. OBJECTIVE The objective of this study is the assessment of PEF and FEV1 variability in (1) healthy children and adolescents, to define the normal daily fluctuation of PEF and FEV1 and the parameters that may influence it, and (2) children and adolescents with asthma, to explore the differences from healthy subjects and reveal any specific variability changes prior to exacerbation. METHODS The study will include 100 healthy children and adolescents aged 6-18 years (assessment of normal PEF and FEV1 variability) and 100 children and adolescents of the same age with diagnosed asthma (assessment of PEF and FEV1 variability in subjects with asthma). PEF and FEV1 measurements will be performed using an ultraportable spirometer (Spirobank Smart; MIR Medical International Research) capable of smartphone connection. Measurements will be performed twice a day between 7 AM and 9 AM and between 7 PM and 9 PM and will be dispatched via email to a central database for a period of 3 months. PEF and FEV1 variability will be assessed by detrended fluctuation and sample entropy analysis, aiming to define the normal pattern (healthy controls) and to detect and quantify any deviations among individuals with asthma. The anticipated duration of the study is 24 months. RESULTS The study is funded by the “C. Caratheodory” Programme of the University of Patras, Greece (PN 47014/24.9.2018). It was approved by the Ethics Committee (decision 218/19-03-2019) and the Scientific Board (decision 329/02-04-2019) of the University Hospital of Patras, Greece. Patient recruitment started in January 2020, and as of June 2020, 100 healthy children have been enrolled (74 of them have completed the measurements). The anticipated duration of the study is 24 months. The first part of the study (assessment of lung function variability in healthy children and adolescents) will be completed in August 2020, and the results will be available for publication by October 2020. CONCLUSIONS Healthy children and adolescents may present normal short- and long-term fluctuations in lung function; the pattern of this variability may be influenced by age, sex, and environmental conditions. Significant lung function variability may also be present in children and adolescents with asthma, but the patterns may differ from those observed in healthy children and adolescents. Such data would improve our understanding regarding the chronobiology of asthma and permit the development of integrated tools for assessing the level of control and risk of future exacerbations. CLINICALTRIAL ClinicalTrials.gov NCT04163146; https://clinicaltrials.gov/ct2/show/NCT04163146 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20350

10.2196/20350 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e20350
Author(s):  
Eirini-Sofia Frima ◽  
Ilias Theodorakopoulos ◽  
Dimos Gidaris ◽  
Nikolaos Karantaglis ◽  
Grigorios Chatziparasidis ◽  
...  

Background Variability analysis of peak expiratory flow (PEF) and forced expiratory volume at 1 second (FEV1) has been used in research to predict exacerbations in adults with asthma. However, there is a paucity of data regarding PEF and FEV1 variability in healthy children and adolescents and those with asthma. Objective The objective of this study is the assessment of PEF and FEV1 variability in (1) healthy children and adolescents, to define the normal daily fluctuation of PEF and FEV1 and the parameters that may influence it, and (2) children and adolescents with asthma, to explore the differences from healthy subjects and reveal any specific variability changes prior to exacerbation. Methods The study will include 100 healthy children and adolescents aged 6-18 years (assessment of normal PEF and FEV1 variability) and 100 children and adolescents of the same age with diagnosed asthma (assessment of PEF and FEV1 variability in subjects with asthma). PEF and FEV1 measurements will be performed using an ultraportable spirometer (Spirobank Smart; MIR Medical International Research) capable of smartphone connection. Measurements will be performed twice a day between 7 AM and 9 AM and between 7 PM and 9 PM and will be dispatched via email to a central database for a period of 3 months. PEF and FEV1 variability will be assessed by detrended fluctuation and sample entropy analysis, aiming to define the normal pattern (healthy controls) and to detect and quantify any deviations among individuals with asthma. The anticipated duration of the study is 24 months. Results The study is funded by the “C. Caratheodory” Programme of the University of Patras, Greece (PN 47014/24.9.2018). It was approved by the Ethics Committee (decision 218/19-03-2019) and the Scientific Board (decision 329/02-04-2019) of the University Hospital of Patras, Greece. Patient recruitment started in January 2020, and as of June 2020, 100 healthy children have been enrolled (74 of them have completed the measurements). The anticipated duration of the study is 24 months. The first part of the study (assessment of lung function variability in healthy children and adolescents) will be completed in August 2020, and the results will be available for publication by October 2020. Conclusions Healthy children and adolescents may present normal short- and long-term fluctuations in lung function; the pattern of this variability may be influenced by age, sex, and environmental conditions. Significant lung function variability may also be present in children and adolescents with asthma, but the patterns may differ from those observed in healthy children and adolescents. Such data would improve our understanding regarding the chronobiology of asthma and permit the development of integrated tools for assessing the level of control and risk of future exacerbations. Trial Registration ClinicalTrials.gov NCT04163146; https://clinicaltrials.gov/ct2/show/NCT04163146 International Registered Report Identifier (IRRID) DERR1-10.2196/20350


2020 ◽  
Author(s):  
Eirini Sofia Frima ◽  
Ilias Theodorakopoulos ◽  
Dimos Gidaris ◽  
Nikolaos Karantaglis ◽  
Grigorios Chatziparasidis ◽  
...  

Abstract Background Variability analysis of peak expiratory flow (PEF) and forced expiratory volume at 1 s (FEV1) has been used in research to predict exacerbations in adult individuals with asthma. However, there is a paucity of data regarding PEF and FEV 1 variability in healthy or asthmatic children and adolescents. The objective of the present study is the assessment of PEF and FEV 1 variability in: a) healthy children and adolescents, to define the normal daily fluctuation of PEF and FEV 1 and the parameters that may influence it, and b) children and adolescents with asthma, to explore the differences from healthy subjects and reveal any specific variability changes prior to exacerbation.Methods The study will include 100 healthy children and adolescents aged 6 to 18 years (assessment of normal PEF and FEV 1 variability) and 100 children and adolescents of the same age with diagnosed asthma (assessment of PEF and FEV 1 variability in asthmatics). PEF and FEV1 measurements will be performed using an ultra-portable spirometer (MIR Spirobank Smart) capable to smartphone connection. Measurements will be performed twice a day between 07:00-09:00 and 19:00-21:00 hours and will be dispatched via email to a central database for a period of 3 months. PEF and FEV1 variability will be assessed by detrended fluctuation and sample entropy analysis, aiming to define the normal pattern (healthy controls) and to detect and quantify any deviations (asthmatics). The anticipated duration of the study is 24 months.Discussion Healthy children and adolescents may present normal short- and long-term fluctuations in lung function; the pattern of this variability may be influenced by age, sex and environmental conditions. Significant lung function variability may also be present in children and adolescents with asthma, but the patterns may differ from those observed in healthy children and adolescents. Such data would improve our understanding regarding the chronobiology of asthma and permit the development of integrated tools for assessing the level of control and risk of future exacerbations.Trial registration ClinicalTrials.gov, NCT04163146. Registered on 14 November 2019


Respiration ◽  
2021 ◽  
pp. 1-10
Author(s):  
Marina Aiello ◽  
Marianna Ghirardini ◽  
Laura Marchi ◽  
Annalisa Frizzelli ◽  
Roberta Pisi ◽  
...  

<b><i>Background:</i></b> Alpha-1 antitrypsin deficiency (AATD) is a hereditary disorder involving lungs, characterized by low serum concentration of the protein alpha-1 antitrypsin (AAT) also called proteinase inhibitor (PI). Asthma is common in AATD patients, but there are only few data on respiratory function in asthmatic patients with AATD. <b><i>Objectives:</i></b> The aim of the study was to evaluate lung function in asthmatic outpatients with mutation in the <i>SERPINA1</i> gene coding for AAT versus asthmatic subjects without mutation. <b><i>Methods:</i></b> We performed the quantitative analysis of the serum concentration of AAT in 600 outpatients affected by mild to moderate asthma from the University Hospital of Parma, Italy. Fifty-seven of them underwent the genetic analysis subsequently; they were subdivided into mutated and non-mutated subjects. All the mutated patients had a heterozygous genotype, except 1 (PI*SS). We assessed the lung function through a flow-sensing spirometer and the small airway parameters through an impulse oscillometry system. <b><i>Results:</i></b> The values of forced vital capacity (% predicted) and those of the residual volume to total lung capacity ratio (%) were, respectively, lower and higher in patients mutated versus patients without mutation, showing a significantly greater air trapping (<i>p =</i> 0.014 and <i>p =</i> 0.017, respectively). Moreover, patients with mutation in comparison to patients without mutation showed lower forced expiratory volume in 3 s (% predicted) and forced expiratory volume in 6 s (L) spirometric values, reflecting a smaller airways contribution. <b><i>Conclusions:</i></b> In asthmatic patients, heterozygosity for AAT with PI*MZ and PI*MS genotypes was associated with small airway dysfunction and with lung air trapping.


Author(s):  
Tobias Hauge ◽  
Dag T Førland ◽  
Hans-Olaf Johannessen ◽  
Egil Johnson

Summary At our hospital, the main treatment for resectable esophageal cancer (EC) has since 2013 been total minimally invasive esophagectomy (TMIE). The aim of this study was to present the short- and long-term results in patients operated with TMIE. This cross-sectional study includes all patients scheduled for TMIE from June 2013 to January 2016 at Oslo University Hospital. Data on morbidity, mortality, and survival were retrospectively collected from the patient administration system and the Norwegian Cause of Death Registry. Long-term postoperative health-related quality of life (HRQL) and level of dysphagia were assessed by patients completing the following questionaries: EORTC QLQ-OG25, QLQ-C30, and the Ogilvie grading scale. A total of 123 patients were included in this study with a median follow-up time of 58 months (1–88 months). 85% had adenocarcinoma, 15% squamous cell carcinoma. Seventeen patients (14%) had T1N0M0, 68 (55%) T2-T3N0M0, or T1-T2N1M0 and 38 (31%) had either T3N1M0 or T4anyNM0. Ninety-eight patients (80%) received neoadjuvant (radio)chemotherapy and 104 (85%) had R0 resection. Anastomotic leak rate and 90-days mortality were 14% and 2%, respectively. The 5-year overall survival was 53%. Patients with tumor free resection margins of &gt;1 mm (R0) had a 5-year survival of 57%. Median 60 months (range 49–80) postoperatively the main symptoms reducing HRQL were anxiety, chough, insomnia, and reflux. Median Ogilvie score was 0 (0–1). In this study, we report relatively low mortality and good overall survival after TMIE for EC. Moreover, key symptoms reducing long-term HRQL were identified.


2021 ◽  
Author(s):  
Yoko Azuma ◽  
Atsushi Sano ◽  
Takashi Sakai ◽  
Satoshi Koezuka ◽  
Hajime Otsuka ◽  
...  

Abstract Background: Chronic obstructive pulmonary disease (COPD) is an important risk factor for postoperative complications and mortality. The utility of several perioperative bronchodilators in patients with COPD requiring surgery for lung cancer has been reported, but the most suitable agent and its specific effect on postoperative long-term prognosis remain unclear. To determine the effects of perioperative combination therapy, using a long-acting muscarinic antagonist (LAMA) and a long-acting β2 agonist (LABA), on preoperative lung function, postoperative morbidity and mortality, and long-term outcome in COPD patients.Methods: Between January 2005 and October 2019, 130 consecutive patients with newly diagnosed COPD underwent surgery for lung cancer. We conducted a retrospective review of their medical records. Patients were divided into 3 groups according to perioperative management: LAMA/LABA (n=64), LAMA (n=23) and rehabilitation only (no bronchodilator) (n=43). Results: Patients who received preoperative LAMA/LABA therapy showed significant improvement in lung function before surgery (p<0.001 for both forced expiratory volume in 1 second (FEV1) and percentage of predicted forced expiratory volume in 1 second (FEV1 %pred). Compared with patients who received preoperative LAMA therapy, patients with LAMA/LABA therapy had significantly improved lung function (ΔFEV1, 223.1 mL vs 130.0 mL, ΔFEV1 %pred, 10.8% vs 6.8%; both p<0.05). There was a trend toward a lower incidence of postoperative complications in the LAMA/LABA group compared with the LAMA and rehabilitation-only groups. In patients with moderate to severe air flow limitation (n=61), those who received LAMA/LABA therapy had significantly longer overall survival and disease-free survival compared with patients in the other groups. Perioperative LAMA/LABA therapy was also associated with lower recurrence rates. Conclusions: Patients who receive perioperative LAMA/LABA for moderate to severe COPD have improved prognosis and better pulmonary function with surgery for lung cancer. We believe this treatment combination is optimal for patients with lung cancer and COPD.


2019 ◽  
Vol 7 ◽  
pp. 205031211882461 ◽  
Author(s):  
Gashaw Garedew Woldeamanuel ◽  
Teshome Gensa Geta

Background: Chronic consumption of khat affects many organ systems and leads to various health disturbances in the chewers. Few studies examined the acute effects of khat ingestion on lung function parameters. However, studies which assessed the long-term effects of khat chewing on pulmonary function parameters and oxygen saturation are lacking. Objective: The aim of this study was to assess the impact of chronic Khat chewing on pulmonary function parameters and oxygen saturation among chronic Khat chewers in Wolkite, Ethiopia. Methods: A community-based comparative cross-sectional study was conducted in Wolkite, Ethiopia from 1 June 2018 to 15 August 2018. A total of 324 participants, 162 khat chewers and 162 non-chewers were included in the study. The data were collected through face-to-face interview by trained data collectors. British Medical Research Council respiratory questionnaire was used to assess respiratory symptoms. A spirometer was used to assess various lung function parameters. Moreover, oxygen saturation of hemoglobin was measured using pulse oximeter. Data were entered into CSPro version 6.2 and analyzed using SPSS version 23. Results: This study showed statistically significant (p < 0.05) reduction in the mean values of forced vital capacity, forced expiratory volume in first second and maximum ventilation volume among khat chewers as compared to non-chewers. There was no significant difference in the mean values of other lung function parameters between the two groups. Similarly, there was no significant difference (p = 0.642) in mean oxygen saturation of hemoglobin (SaO2) across the two groups. Conclusion: It is evident from this study that long-term khat consumption is associated with decreased mean forced vital capacity, forced expiratory volume in first second and maximum ventilation volume. Hence, there is a need for further study to strengthen the current findings and to explore the mechanisms of khat chewing effect on lung function parameters.


Author(s):  
Vanessa Rentrop ◽  
Johanna Sophie Schneider ◽  
Alexander Bäuerle ◽  
Florian Junne ◽  
Nora Dörrie ◽  
...  

Abstract Due to the SARS CoV-2-virus (COVID-19), anxiety, distress, and insecurity occur more frequently. In particular, infected individuals, their relatives, and medical staff face an increased risk of high psychological distress as a result of the ongoing pandemic. Thus, structured psychosocial emergency concepts are needed. The University hospital of Essen has taken up this challenge by creating the PEC concept to reduce psychosocial long-term consequences for infected patients, relatives, and medical staff at the university hospital. The concept includes professional medical as well as psychological support to convey constructive coping strategies and the provision of adequate tools such as the low-threshold online training program (CoPE It), which is accessible via the webpage www.cope-corona.de.


2019 ◽  
Vol 8 (4) ◽  
pp. 562
Author(s):  
Hung-Yu Huang ◽  
Chun-Yu Lo ◽  
Lan-Yan Yang ◽  
Fu-Tsai Chung ◽  
Te-Fang Sheng ◽  
...  

Negative pressure ventilation (NPV), when used as an adjuvant to pulmonary rehabilitation, improves lung function, increases exercise capacity, and reduces exacerbations. The aim of this study was to determine whether maintenance NPV improves long-term clinical outcomes and reduces mortality in patients with chronic obstructive pulmonary disease (COPD). Between 2003 and 2009, 341 patients were treated for COPD either with or without hospital-based NPV. We measured forced expiratory volume in one second (FEV1), 6-min walking distance (6MWD), and oxygen saturation by pulse oximetry (SpO2) during a 6-min walk test (6MWT) every 3–6 months. Desaturation (D) during the 6MWT was defined as a reduction in SpO2 of ≥10% from baseline. The NPV group had a better survival outcome than the Non-NPV group. The 8-year survival probabilities for the NPV and Non-NPV groups were 60% and 20%, respectively (p < 0.01). Baseline desaturation was a significant risk factor for death, and the risk of death increased with desaturation severity (SpO2 80~89: hazard ratios (HR) 2.7, 95% confidence interval (CI) 1.4–5.3; SpO2 < 80: HR 3.1, 95% CI 1.3–7.4). The NPV group had a slower decline in lung function and 6MWD. The NPV + D and Non-NPV+D had a threefold and fourfold increase in the risks of all-cause mortality compared with the NPV-ND, respectively. Maintenance non-invasive NPV reduced long-term mortality in COPD patients. The desaturating COPD patients had an increased mortality risk compared with non-desaturating COPD patients.


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