Comparison of Mesh Nebulizer and Compressor Nebulizer With Pulmonary Function Test in Pediatric Asthma Attacks

January 9, 2024 updated by: Berker Okay

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sultangazi
      • Istanbul, Sultangazi, Turkey, 34304
        • UHS Haseki Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Asthma attack patients who need inhaler therapy (salbutamol)
  • Patients aged 7-15 years and whose families gave consent for the study

Exclusion Criteria:

  • Patients with neuromotor impairment
  • Patients with underlying chronic disease (neurological disease such as epilepsy or congenital heart disease)
  • Patients with obesity or malnutrition (to equalize drug dose efficacy)
  • Patients with those receiving adrenaline, budesonide or ipratropium bromide therapy
  • Patients who have used a long-acting bronchodilator in the last 12 hours or a short-acting bronchodilator in the last 2 hours
  • Patients with fever above 37.5°C
  • Patients with a saturation value below 92% at the time of admission
  • Patients with severe asthma attack
  • Patients with respiratory failure
  • Patients who had problems in performing the test (such as mental retardation, patient incompatibility)
  • Patients with diseases involving the chest muscles and those with chronic lung diseases (such as cystic fibrosis, bronchiectasis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group receiving inhaled treatment with compressor nebulizer
Salbutamol inhaler, Omron® CompAIR Pro NE-C900 Compressor Nebulizer (Omron Healthcare Co., Ltd., Kyoto, Japan) was used in Group 1
Device: Group 1
Salbutamol inhaler, Omron® CompAIR Pro NE-C900 Compressor Nebulizer (Omron Healthcare Co., Ltd., Kyoto, Japan) was used in Group 1
Active Comparator: Group receiving inhaled treatment with mesh nebulizer
Salbutamol inhaler, Mesh nebulizer (Aerogen Solo®, Aerogen Ltd, Galway, Ireland) was used in Group 2
Device: Group 2
Salbutamol inhaler, Mesh nebulizer (Aerogen Solo®, Aerogen Ltd, Galway, Ireland) was used in Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mesh nebulizer improves pulmonary function test results more effectively in children
Time Frame: 1 hour

Pulmonary function test results in children using mesh nebulizers may be improving more effectively.

To compare mesh and compressor nebulizers, we planned to compare FEV1, FVC, FEV1/FVC, FEF 25-75 and PEF in pulmonary function testing.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berker Okay

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

July 15, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

December 25, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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