Evaluation of the Efficacy of Different Nebulization Techniques

NCT ID: NCT05507060

Last Updated: 2022-08-18

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-09-25

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.

Detailed Description

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Conditions

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COPD Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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

Study Groups

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Vibrating MESH nebulizer

Medication will be applied with Vibrating MESH nebulizer

Group Type ACTIVE_COMPARATOR

Vibrating MESH nebulizer (Aerogen Ultra)

Intervention Type DEVICE

Medication will be applied with Vibrating MESH nebulizer

Jet nebulizers

Medication will be applied with Jet nebulizers

Group Type ACTIVE_COMPARATOR

Jet nebulizers (Philips Respironics)

Intervention Type DEVICE

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

Intervention Type DEVICE

Jet nebulizers (Philips Respironics)

Medication will be applied with Jet nebulizers

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Erdem Cevik

Associate Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sultan Abdulhamid Han Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Erdem Cevik, MD

Role: CONTACT

+905054515930

Facility Contacts

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Erdem Cevik, MD

Role: primary

+905054515930

Melih Arınc, MD

Role: backup

+905385192804

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.

Reference Type BACKGROUND
PMID: 32694180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34849428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33987289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31613690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30943978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31378412 (View on PubMed)

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.

Reference Type RESULT
PMID: 30545350 (View on PubMed)

Related Links

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https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp

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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