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Comparison of Mesh Nebulizer and Compressor Nebulizer on Pulmonary Function Test in Children Presenting With Asthma Attack: A Double-Blind Randomized Comparative Clinical Trial
Asthma is a worldwide health problem and is one of the most common chronic diseases of childhood in most countries. Symptoms begin before the age of 5 years in 80% of children with asthma, but the diagnosis is not always easy. The National Asthma Education and Prevention Program (NAEPP) expert panel recommends spirometry testing for children over 5 years of age. Spirometry measurements include forced vital capacity (FVC) and the forced expiratory volume in first second (FEV1). Airflow obstruction is defined as FEV1 reduced to less than 80 percent predicted and an FEV1/FVC ratio of less than 0.85 (85 percent). Reference values are based on age, height, sex, and race. Forced expiratory flow between 25 and 75 percent of vital capacity (FEF25-75) less than 65 percent correlates with reversible airflow obstruction in children with normal FEV1 and may be a useful measure in this subgroup. In the spirometry test, FEV1, FVC, FEF 25-75% values are valuable for the follow-up of asthma. While the FEV1/FVC ratio is above 80% in healthy children, it may decrease below 75% in diseases such as asthma. Likewise, FEV1 and FEF can be found to be low in 50-75% of asthma patients. In addition, these values can be used to determine the effectiveness of the inhaler given with the nebulizer given during the attack. Spirometry should be performed before and after administration of a bronchodilator to assess for reversibility (bronchodilator response \[BDR\]) even in children with a normal baseline FEV1 because many of these children will still have a BDR (both within the normal range and sometimes also supranormal) after treatment. Significant reversibility is indicated by an increase in FEV1 of ≥12 percent from baseline after administration of a short-acting bronchodilator. This definition for BDR positivity was established primarily in adults. An increase in FEV1 of ≥8 percent may be a better definition for BDR in children. Inhaled short-acting beta-2 agonists, particularly albuterol (salbutamol), are the standard emergent treatment for acute asthma exacerbations in all patients based upon adult data. It is recommended to be given every 20 minutes in case of need for repeated doses in mild and moderate asthma attacks. Different types of nebulizers can be used for inhaler therapy; they can convert drugs into vapor form with sound waves, compressed air or by using electrical energy. While compressor nebulizers convert the liquid drug into aerosol form with compressed air, mesh nebulizers convert the drug into aerosol form with the vibrations they create with the help of electrical energy. Mesh nebulizers are more effective than other types of nebulizers, and the amount left in the chamber is less than other models, and it can decompose the drug into smaller particles and reach the more extreme branches of the lung. In our study, the investigators aimed to determine which nebulizer type is more effective by comparing the effects of mesh nebulizer and compressor nebulizer on spirometry test in children presenting with asthma attack. Thus, the investigators planned to find the most comfortable and effective method for patients by determining the appropriate nebulization technique for patients.
Age
7 - 15 years
Sex
ALL
Healthy Volunteers
No
UHS Haseki Training and Research Hospital
Istanbul, Sultangazi, Turkey (Türkiye)
Start Date
August 1, 2022
Primary Completion Date
July 15, 2023
Completion Date
August 1, 2023
Last Updated
January 18, 2024
80
ACTUAL participants
Group 1
DEVICE
Group 2
DEVICE
Lead Sponsor
Berker Okay
NCT02327897
NCT07219173
NCT07486401
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