Evaluation of the Efficacy of Different Nebulization Techniques

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status: Enrolling

Conditions: COPD Exacerbation

Treatments: Device: Jet nebulizers (Philips Respironics); Device: Vibrating MESH nebulizer (Aerogen Ultra)

Study type: Interventional

Funder types: Other

Identifiers

NCT05507060

Ecevik1

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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96 participants in 2 patient groups

Vibrating MESH nebulizer

Active Comparator group

Description:

Medication will be applied with Vibrating MESH nebulizer

Treatment:

Device: Vibrating MESH nebulizer (Aerogen Ultra)

Jet nebulizers

Active Comparator group

Description:

Medication will be applied with Jet nebulizers

Treatment:

Device: Jet nebulizers (Philips Respironics)