Evaluation of the Efficacy of Different Nebulization Techniques
NCT ID: NCT05507060
Last Updated: 2022-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
96 participants
INTERVENTIONAL
2022-08-01
2022-09-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Vibrating MESH nebulizer
Medication will be applied with Vibrating MESH nebulizer
Vibrating MESH nebulizer (Aerogen Ultra)
Medication will be applied with Vibrating MESH nebulizer
Jet nebulizers
Medication will be applied with Jet nebulizers
Jet nebulizers (Philips Respironics)
Medication will be applied with Jet nebulizers
Interventions
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Vibrating MESH nebulizer (Aerogen Ultra)
Medication will be applied with Vibrating MESH nebulizer
Jet nebulizers (Philips Respironics)
Medication will be applied with Jet nebulizers
Eligibility Criteria
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Inclusion Criteria
* Being over 18 years old,
* Being able to read and to understand the spoken language and give consent.
Exclusion Criteria
* Covid 19 or suspected patients
* cognitive disorders
18 Years
ALL
No
Sponsors
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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
OTHER
Responsible Party
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Erdem Cevik
Associate Prof.
Locations
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Sultan Abdulhamid Han Research and Training Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Dogan NO, Varol Y, Kokturk N, Aksay E, Alpaydin AO, Corbacioglu SK, Aksel G, Baha A, Akoglu H, Karahan S, Sen E, Ergan B, Bayram B, Yilmaz S, Gurgun 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.
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.
Gerde P, Nowenwik M, Sjoberg 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.
Sweeney L, McCloskey AP, Higgins G, Ramsey JM, Cryan SA, MacLoughlin R. Effective nebulization of interferon-gamma using a novel vibrating mesh. Respir Res. 2019 Apr 3;20(1):66. doi: 10.1186/s12931-019-1030-1.
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.
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/s12931-018-0944-3.
Related Links
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KOAH alevlenme ile acil servis'e başvuran hastalarda, spirometrik ölçümler, ciddiyet skorları ve laboratuvar parametrelerinin prognozu öngörmedeki değeri
Other Identifiers
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Ecevik1
Identifier Type: -
Identifier Source: org_study_id
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