Telemonitoring of Lung Function by Spirometry
Mo kle
Abstrè
Deskripsyon
Asthma is the most common respiratory disorder in children characterized by periodic airway obstruction, bronchial hyper-responsiveness, and airway inflammation. The symptoms of asthma may include cough, wheeze, or bronchoconstriction with airflow limitation. The severity of asthma may vary from mild to severe. Mild asthma is associated with rear events of short of breath. However, the exacerbation of the disease often leads to acute respiratory adverse events with severe hypoxia that requires hospitalization. The hospital care involves travel costs for the children and parents, school and work absenteeism.
The primary objective of the study is to investigate whether the annual occurrence of asthma exacerbation can be decreased by the use of the telespirometry system. Another objective is to determine which lung function parameters are best to predict asthma exacerbation.
To address these aims we plan to involve two groups (telemonitoring and control) of asthmatic children with GINA 2-5 stage under 18 years of age. Poor general condition, any disease which endangers the health of the volunteer or contraindicates the study and lack of parental consent are defined as the exclusion criteria.
The lung function in the children in both groups will be monitored by conventional spirometric assessment performed at the Department of Pediatrics and Pediatric Health Care Center of the University of Szeged. After each lung function assessments children will be asked to fill the Asthma Control Test (ACT).
Patients in the telemedicine group receive the home mobile controlled spirometer and trained by a pediatric pulmonologist for home examination. The spirometers are handed for 12 months, and children are asked to perform measurements minimum 4 times per week (at least one day a week in the morning and in the evening). In the case of asthma exacerbation, more frequent measurements repeated several times a day are required. Children in the telemedicine group complete the ACT after each measurement, which provides a numerical score related to the severity of asthma symptoms. Lung function parameters measured by children and the ACT test results are automatically uploaded to a clinical server where the pulmonologists and built-in algorithms are monitoring the quality of the data. In case of deterioration of the lung function parameters, the patients are called for a personal visit and their treatment can be revised.
Every three months, members of both groups come to the outpatient clinic for a personal visit, where the same examinations are performed.
Dat
Dènye verifye: | 02/29/2020 |
Premye Soumèt: | 06/16/2020 |
Enskripsyon Estimasyon Soumèt: | 06/23/2020 |
Premye afiche: | 06/24/2020 |
Dènye Mizajou Soumèt: | 06/23/2020 |
Dènye Mizajou afiche: | 06/24/2020 |
Dat aktyèl kòmanse etid la: | 06/29/2020 |
Dat Estimasyon Prensipal Estimasyon an: | 05/30/2021 |
Dat estime fini etid la: | 07/30/2021 |
Kondisyon oswa maladi
Entèvansyon / tretman
Device: Telemedicine arm
Faz
Gwoup bra
Bra | Entèvansyon / tretman |
---|---|
Experimental: Telemedicine arm | Device: Telemedicine arm Components of the system: Portable digital ultrasonic spirometer (Uscom SpiroSonic MOBILE), android mobile application, clinical web cloud application |
No Intervention: Control arm |
Kritè kalifikasyon yo
Laj ki kalifye pou etid | 6 Years Pou 6 Years |
Sèks ki kalifye pou etid | All |
Aksepte Volontè Healthy | Wi |
Kritè | Inclusion Criteria: - Younger than 18 years - signed ICF - asthmatic children with 2-5 GINA score - The children is open-minded for telespirometric measurements at home and is capable for those measurements - Parent understands and supports the investigation Exclusion Criteria: - Withdrawal of consent - Any disease which, by the investigators opinion, is a risk for the patients health and/or is contraindicating the participation in the study - Bad general condition |
Rezilta
Mezi Rezilta Prensipal yo
1. Incidence of asthma exacerbations per year [12 months]
Mezi Rezilta Segondè
1. expiratory Forced Vital Capacity (FVC), the maximum amount of air that can forcibly be blown out after full inspiration [12 months]
2. Forced Expiratory Volume in one second (FEV1), is the volume of air that can forcibly be blown out in first 1 second after full inspiration [12 months]
3. FEV1/FVC ratio (FEV1%) [12 months]
4. Peak Expiratory Flow (PEF), peak expiratory flow rate during expiration [12 months]
5. Forced Expiratory Flow at 25-75% of FVC (FEF25-75%), mean of forced expiratory flow over the middle half of the FVC [12 months]
6. The change of absenteeism days from work/school [12 months]