Evaluation of the Efficacy of Different Nebulization Techniques

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507060
• Other study ID #: Ecevik1
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: September 25, 2022

Study information

• Verified date: August 2022
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: Erdem Cevik, MD
• Phone: +905054515930
• Email: cevikerdem[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: September 25, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD Exacerbation

Intervention

Device:
• Vibrating MESH nebulizer (Aerogen Ultra)
Medication will be applied with Vibrating MESH nebulizer
• Jet nebulizers (Philips Respironics)
Medication will be applied with Jet nebulizers

Locations

Country	Name	City	State
Turkey	Sultan Abdulhamid Han Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Ashraf S, McPeck M, Cuccia AD, Smaldone GC. Comparison of Vibrating Mesh, Jet, and Breath-Enhanced Nebulizers During Mechanical Ventilation. Respir Care. 2020 Oct;65(10):1419-1426. doi: 10.4187/respcare.07639. Epub 2020 Jul 21. — View Citation

Dailey PA, Shockley CM. Review of aerosol delivery in the emergency department. Ann Transl Med. 2021 Apr;9(7):591. doi: 10.21037/atm-20-4724. Review. — View Citation

Dogan NÖ, Varol Y, Köktürk N, Aksay E, Alpaydin AÖ, Çorbacioglu SK, Aksel G, Baha A, Akoglu H, Karahan S, Sen E, Ergan B, Bayram B, Yilmaz S, Gürgün A, Polatli M. 2021 Guideline for the Management of COPD Exacerbations: Emergency Medicine Association of Turkey (EMAT) / Turkish Thoracic Society (TTS) Clinical Practice Guideline Task Force. Turk J Emerg Med. 2021 Oct 29;21(4):137-176. doi: 10.4103/2452-2473.329630. eCollection 2021 Oct-Dec. — View Citation

Gerde P, Nowenwik M, Sjöberg CO, Selg E. Adapting the Aerogen Mesh Nebulizer for Dried Aerosol Exposures Using the PreciseInhale Platform. J Aerosol Med Pulm Drug Deliv. 2020 Apr;33(2):116-126. doi: 10.1089/jamp.2019.1554. Epub 2019 Oct 15. — View Citation

Kocak AO, Cakir Z, Akbas I, Gur STA, Kose MZ, Can NO, Sengun E, Gemis OF. Comparison of two scores of short term serious outcome in COPD patients. Am J Emerg Med. 2020 Jun;38(6):1086-1091. doi: 10.1016/j.ajem.2019.158376. Epub 2019 Jul 27. — View Citation

Sweeney L, McCloskey AP, Higgins G, Ramsey JM, Cryan SA, MacLoughlin R. Effective nebulization of interferon-? using a novel vibrating mesh. Respir Res. 2019 Apr 3;20(1):66. doi: 10.1186/s12931-019-1030-1. — View Citation

Watz H, Tetzlaff K, Magnussen H, Mueller A, Rodriguez-Roisin R, Wouters EFM, Vogelmeier C, Calverley PMA. Spirometric changes during exacerbations of COPD: a post hoc analysis of the WISDOM trial. Respir Res. 2018 Dec 13;19(1):251. doi: 10.1186/s12931-018 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of spirometric measurement	Change of FEV 1%, FVC %, FEV1 / FVC %, FEF 50 %, FEF 2575 %	Change from pretreatment spirometric measurements at first hour.
Primary	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.
Primary	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	nebulization time	time from start to end of nebulization treatment will measured in minutes	Measured with each nebulization treatment at first hour
Secondary	patient satisfaction	Satisfaction of nebulization treatment ( 5 Lincert scale)	Measured after each nebulization application at first hour.

External Links

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