Bacterial Lysate In Preventing Asthma
Respiratory Tract InfectionsPediatric Respiratory Diseases1 moreBronchiolitis is a common viral infection of the small airways of infants and some affected infants will require hospital admission. Severe bronchiolitis is a marker for greatly increased risk of developing both preschool wheeze and subsequent school age asthma. Since epidemiological studies suggest that exposure to microbial products protects against preschool wheeze, lysates of bacteria may prevent the development of wheeze after bronchiolitis, with long-term beneficial consequences. BLIPA is a phase 2b, randomised, double blind, placebo-controlled study, investigating the efficacy superiority of bacterial lysate (Broncho Vaxom) capsules over placebo, in reducing wheeze in infants after severe bronchiolitis. The primary end point of the study is parent-reported, healthcare-professional confirmed wheeze at 19-24 months. The study aims to test bacterial lysate capsules (3.5mg over 24 months) for safety, efficacy, and to advance mechanistic understanding of its action.
The Effect of Noise Pollution on Lung Sound Recognition by Medical Students
Lung SoundTitle: The Effect of White Noise on the Ability of a Medical Student to Recognise Correctly Adventitious Lung Sound. Methodology: Randomized, controlled trial, blind study. Study Duration: The estimated duration for the main protocol (e.g., from the start of screening to the last subject processed and finishing the study) is approximately 4 weeks. Study Centre: Lithuanian University of Health Sciences (LSMU) and Kaunas Hospital of LSMU. Objectives: Primary Objective: To evaluate the accuracy of second-year and third-year medical students in correctly identifying pathological and nonpathological lung sounds under different white noise levels. Number of Subjects: A group of 104 students will be exposed (EXP) to learning pathological and nonpathological sounds for 3 days. After 3 days students will take 3 tests with different levels of white noise pollution added ( signal-to-noise ratio (SNR) 20, 40 and none added). Diagnosis and Main Inclusion Criteria: Inclusion Criteria: male and female second and third-year LSMU students; 18-40 years old; in any distribution. Consent and compliance with all aspects of the study protocol, and methods, providing data during follow-up contact. Please, see the methods section for a full list of inclusion criteria. Exclusion Criteria: deafness; age over 40; conditions that prevent the student from using earphones. Please, see the methods section for a full list of exclusion criteria. Regimen: EXP group will receive 3-day training of 101 lung sounds. Statistical Methodology: Results will be analyzed with the SPSS (version 27) and Jamovi (version 2.3.21). A p-value < 0.05 will be considered statistically significant. The effect of 3 levels of white noise on the EXP group will be compared utilizing a one-way analysis of variance (ANOVA) statistical test. Though, if data does not adhere to a normal distribution then Kruskal - Wallis will be applied. McNemar's test will be used to compare if there was a statistical difference between second-year and third-year students.
Predicting Post Extubation Stridor After Maxillomandibular Fixation
StridorLarynx EdemaEndotracheal intubation can induce laryngotracheal injury which results in narrowing of the airway due to edema of the glottis. This can increase the risk of development of post-extubation stridor (PES)
Relationship Between Acoustic Breath Sounds and Spirometry
Asthma COPDThe goal of this clinical trial is to assess whether wheeze as assessed by a commercially available wheeze monitor is comparable to lung function as measured during a spirometry test. The main questions it aims to answer are whether measures of airflow obstruction (FEV1, FEV1/FVC, PEF) correlate with wheeze score (Tw/Ttot%). Participants consenting to take part will undergo wheeze measurement prior to and during a spirometry test and will be asked to complete a series of symptom questionnaires.
The Efficacy of Medical Students to Identify Pathological Lung Sound Over a Period of Time
Lung SoundTitle: The efficacy of medical students to correctly recognise pathological from non-pathological lung sounds over a period of time. Methodology: Randomised, controlled trial, blind study. Study Duration: The estimated duration for the main protocol (e.g., from the start of screening to the last subject processed and finishing the study) is approximately 6 months. Study Centre: Lithuanian University of Health Sciences (LSMU). Objectives: Primary Objective: To evaluate the accuracy of second-year & third-year students in correctly identifying pathological and not pathological lung sounds. Secondary Objectives: To evaluate the loss of the ability of the student to correctly identify pathological lung sounds over a period of time. Number of Subjects: 140 randomised students in two groups; the first group is the control group (CNT), and a second group (EXP) will be exposed to pathological and none pathological lung sounds. Diagnosis and Main Inclusion Criteria: Inclusion Criteria · Male and female second and third-year LSMU students, 18-40 years old, in any distribution. · Consent and compliance with all aspects of the study protocol, and methods, providing data during follow-up contact · See the methods section for the full list of inclusion criteria. Exclusion Criteria · Deafness · Age over 40 · Conditions that prevent the student from using earphones · See the methods section for a full list of exclusion criteria. Regimen: CNT group will not receive training. Whilst group will receive 3-day training for 21 patient cases (57% with pathological lung sounds). Statistical Methodology: Results will be analysed with the SPSS (version 27). A p-value < 0.05 will be considered statistically significant. The groups (CNT vs EXP) will be compared with the independent Student's t-test to see if there is a significant difference between the mean of the two groups. Though, if the data does not adhere to the parametric test's criteria a Mann-Whitney test will be applied. Whilst for the measurement made over 6 months of students' sensitivity, specificity, and accuracy (at intervals of 4, 10, 34, 184 -days) a one-way analysis of variance (ANOVA) statistical test will be applied for normally distributed data. Whilst, if data is not normally distributed a none parametric test will be applied such as Kruskal - Wallis method. McNemar's test will be applied to compare the performances of the same EXP students between their second- and third-year peers.
Respiratory Monitoring System Safety and Performance Study
Pulmonary Function TestTidal Volume3 moreThe goal of this observational study is collect data to evaluate the efficacy of the RMS system in monitoring, recording, and presenting respiratory function data to the user in participants scheduled for pulmonary function testing (PFT). Participants will complete: 60 episodes of data collection with a decreased tidal volume 30 episodes of data collection with an increased tidal volume 80 episodes with normal tidal volume breathing The TSS will continuously transmit sound data to an adjacent personal computer (PC) via Bluetooth Low-Energy (BLE). TSS trachea sound data will be recorded on the PC and then transmitted via a secure wireless network to an RTM cloud account that is HIPPA compliant. Reference breathing data will be simultaneously recorded using an FDA approved hospital ventilator (Hamilton Medical, HAMILTON-C1) with a calibrated pneumotach, capnometer, and a tight-fitting face mask. This system accurately measures and records a spontaneously breathing patient's RR, TV, MV, and end-tidal carbon dioxide concentration.
Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness
AsthmaWheezingThe primary objective of this study is to evaluate if Broncho-Vaxom® given to high risk infants for 10 days, monthly, for two consecutive years can increase time to occurrence of the first episode of wheezing lower respiratory tract illness (WLRI) during a three year observation period off therapy.
Measurement of Expiratory Flow Variability for the Detection of Bronchospasm in Infants Using the...
HealthyWheezing1 moreWheezing in infants and children less than 3 years of age children is a frequent feature that might be difficult to diagnose when only the caregivers reporting is available. Indeed, in this age group the usual reversible flow limitation measure during pulmonary function testing (PFT) is missing because PFT techniques require the full patient cooperation to perform respiratory tests. Infants PFTs have been developed to measure the same indexes than those measured in adults, but they are difficult to set-up and require medication- induced sleep during day time. However, when flow limitation is sufficient it can be detected during tidal breathing as measured during spirometry using pneumotachograph (PNT). In this test, the tidal breathing flow-volume (TBFV) loop is recorded and studied using different indices to assess the airflow limitation. But, there again, when addressing infants or very young children quiet breathing can only be achieved during sleep and medication- induced sleep necessary. Impedance pneumography (IP) is a method for measuring changes in the thoracic electrical impedance through skin electrodes, which varies as a function of lung aeration i.e. breathing. This technique has mainly been applied to monitor respiratory rate in intensive care settings, but recent technical advancements in IP signal processing and electrode placement strategy have enabled IP to be used for accurate non-invasive tidal flow signal measurement. Compared to direct PNT, high agreement in flow signal and TBFV indices has been demonstrated in young children as well as in infants, even during induced bronchoconstriction. Moreover, in overnight recordings at home, IP was found feasible for quantifying nocturnal TBFV variability in young children with lower respiratory symptoms. In this study, it was shown that preschool children with high risk of asthma present with increased variation of tidal flow profile shape, and momentarily lowered chaoticity, compared to children with lower risk of asthma. Recently a study in Tampere University Hospital (TAUH) Allergy centre (Tampere, Finland, PSHP ethical committee code R14027, ClinicalTrials.gov code NCT02164968) finished collecting overnight TBFV using impedance pneumography on 70 young children with suspected asthma. The preliminary analysis of this data shows that the effect of asthma treatment can be seen in TBFV variability, but to assess the diagnostic capacity of this new method, healthy control sample should be collected. The technology developed by the Finnish medical device company Revenio Research Oy enables to evaluate the variability of the expiratory flow-volume curve. It is calculate as the expiration variability index (EVI) which is decreased in case of bronchoconstriction. In order to explore very young children (less than 3 years of age) unable to participate to any awake lung function test, we set-up a study aiming to: 1) establish reference value for EVI in healthy children 2 months to 3 years old 2) test the variation of EVI in case of acute disease with or without wheezing in this age group children. In this observational prospective multicenter study, we will include 110 asymptomatic healthy subjects to compute reference values of EVI. We will also include 35 previously healthy subjects who have developed an acute non wheezing disease such as fever, rhinitis, otitis or bronchitis to compare their EVI to the reference values. And finally, we will recruit 35 young subjects with an acute wheezing episode. All measurements will be performed at home by the parents, except for some wheezy children who could be hospitalized. It will be proposed to record 2 consecutive nights in healthy asymptomatic children in order to evaluate the night-to-night variability which has already shown to be small in older children. In this multicentre study 120 children will be recruited by the present study in France and the remaining 60 children in another English centre using the same design and technology. It is expected that only children with acute wheezing episode will have a significantly low EVI compare to the reference values established by this study.
Pulmonary Epithelium, Immunology and Development of Asthma: Breathing Together
AsthmaWheezingThe investigators want to know why some babies wheeze and some of these go on to develop asthma. The investigators are going to find out if babies who develop wheeze and asthma have abnormal airway lining cells (taken from the nose) when they are born and what happens to these cells as they get older. The study will last three years. Parents will be asked to fill in a monthly health questionnaire. The tests on the babies are all in routine clinical use: a urine sample, a blood test from a heel or finger prick, swabs from the nose and throat to look at the microbiome, and a brushing of cells from the inside of the nose. These tests will be performed at 5-10 days old, and at one and three years. Parents will be asked to fill in online monthly health questionnaire. Some babies will have the swabs repeated at 3 and 6 months, and those who wheeze in the first 3 years of life, samples during the illness and after recovery.
VCSIP Follow-up Study
AsthmaPulmonary Function2 moreThe overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function and decrease wheeze at 5 years of age in their offspring. This is a continuation of the VCSIP trial, to follow the offspring through 5 years of age. The hypothesis for this protocol is an extension of the VCSIP trial that supplemental vitamin C in pregnant smokers can significantly improve their children's PFTs and decrease the incidence of wheeze.