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Evaluation of the Efficacy of Different Nebulization Techniques

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05507060
Enrollment
96
Registered
2022-08-18
Start date
2022-08-01
Completion date
2022-09-25
Last updated
2022-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

Keywords

COPD, nebulizers

Brief summary

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.

Interventions

DEVICEVibrating MESH nebulizer (Aerogen Ultra)

Medication will be applied with Vibrating MESH nebulizer

DEVICEJet nebulizers (Philips Respironics)

Medication will be applied with Jet nebulizers

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change of spirometric measurementChange from pretreatment spirometric measurements at first hour.Change of FEV 1%, FVC %, FEV1 / FVC %, FEF 50 %, FEF 2575 %
Change of Integrated pulmonary index( IPI)Change from pretreatment IPI at first hour.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
VAS score change of dyspneaChange from pretreatment VAS score at first hour.0 is no dyspnea and 10 is the biggest dyspnea attacks

Secondary

MeasureTime frameDescription
nebulization timeMeasured with each nebulization treatment at first hourtime from start to end of nebulization treatment will measured in minutes
patient satisfactionMeasured after each nebulization application at first hour.Satisfaction of nebulization treatment ( 5 Lincert scale)

Countries

Turkey (Türkiye)

Contacts

Primary ContactErdem Cevik, MD
cevikerdem@yahoo.com+905054515930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026