Evaluation of the Efficacy of Different Nebulization Techniques

Study Overview
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Brief Summary
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COPD is the 3rd most common cause of death in the world, and the most common places of admission in our country with exacerbation of COPD are emergency services. β-2 agonists and/or short-acting anticholinergic drugs use is recommended in patients with COPD Salbutamol is known to cause significant improvement in dyspnea, quality of life and FEV1 in patients with COPD. Various techniques are used to administer drugs, one of which is the nebulization technique and is frequently used in emergency departments. There are limited clinical studies comparing different nebulization techniques, and the aim of this study is to compare the efficacy of Vibrating MESH nebulizer versus Jet nebulizers in a COPD exacerbation patient. Patients who applied to the Emergency Department of Sultan Abdulhamid Han Training and Research Hospital with the complaint of shortness of breath and were diagnosed with COPD exacerbation according to the Gold Guidelines and to be treated with nebulization will be included in the study. Patients who agreed to participate in the study will be divided into two groups and assigned sequentially according to the simple randomization schedule. Medication will be applied to one group with Jet nebulizers (Philips Respironics) and to the other group with Vibrating MESH nebulizer (Aerogen Ultra). Vital signs, IPI, spirometric measurements (FEV 1, FVC, FEV1 / FVC, FEF 50, FEF 2575), and dyspnea VAS score will be recorded at admission and re-measured after 1hour of treatment . In addition, single dose nebulization time will be measured and patient satisfaction will be measured with a 5-linkert scale. Demographic data will be recorded. The measurements will be recorded in the patient file and the groups will be coded so that the researcher evaluating the data will be blinded to the groups. The patient could not be blinded because of the different shape of devices.

Official Title
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Evaluation of the Efficacy of Different Nebulization Techniques in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Patients, Randomized, Single-blind, Clinical Trial

Conditions
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COPD Exacerbation

Intervention / Treatment
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* Device: Vibrating MESH nebulizer (Aerogen Ultra)
* Device: Jet nebulizers (Philips Respironics)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute exacerbation of COPD according to GOLD guidline, Being over 18 years old, Being able to read and to understand the spoken language and give consent. Exclusion Criteria: Patients who need NIMW or intubation. Covid 19 or suspected patients cognitive disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vibrating MESH nebulizer<br>Medication will be applied with Vibrating MESH nebulizer | Device: Vibrating MESH nebulizer (Aerogen Ultra)<br>* Medication will be applied with Vibrating MESH nebulizer<br>|
| Active Comparator: Jet nebulizers<br>Medication will be applied with Jet nebulizers | Device: Jet nebulizers (Philips Respironics)<br>* Medication will be applied with Jet nebulizers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of spirometric measurement | Change of FEV 1%, FVC %, FEV1 / FVC %, FEF 50 %, FEF 2575 % | Change from pretreatment spirometric measurements at first hour. | 
| Change of Integrated pulmonary index( IPI) | IPI will measured by Capnostream™ 35 Portable Respiratory Monitor. The device can give single digit, 1-10. 10 is normal and 1-2 is need immediately intervention | Change from pretreatment IPI at first hour. | 
| VAS score change of dyspnea | 0 is no dyspnea and 10 is the biggest dyspnea attacks | Change from pretreatment VAS score at first hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nebulization time | time from start to end of nebulization treatment will measured in minutes | Measured with each nebulization treatment at first hour | 
| patient satisfaction | Satisfaction of nebulization treatment ( 5 Lincert scale) | Measured after each nebulization application at first hour. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, nebulizers