Evaluation of the Efficacy of Different Nebulization Techniques

NCT05507060 | Unknown

• 1 other identifier: Ecevik1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Keywords

COPD; nebulizers

Outcome Measures

Primary Outcomes (3)

• change of spirometric measurement

  Change of FEV 1%, FVC %, FEV1 / FVC %, FEF 50 %, FEF 2575 %

  Change from pretreatment spirometric measurements at first hour.

• 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.

• 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 Outcomes (2)

• nebulization time

  Measured with each nebulization treatment at first hour

• patient satisfaction

  Measured after each nebulization application at first hour.

Study Arms (2)

Vibrating MESH nebulizer

ACTIVE COMPARATOR

Medication will be applied with Vibrating MESH nebulizer

Device: Vibrating MESH nebulizer (Aerogen Ultra)

Jet nebulizers

ACTIVE COMPARATOR

Medication will be applied with Jet nebulizers

Device: Jet nebulizers (Philips Respironics)

Interventions

Vibrating MESH nebulizer (Aerogen Ultra) DEVICE

Medication will be applied with Vibrating MESH nebulizer

Vibrating MESH nebulizer

Jet nebulizers (Philips Respironics) DEVICE

Medication will be applied with Jet nebulizers

Jet nebulizers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who need NIMW or intubation.
• Covid 19 or suspected patients
• cognitive disorders

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan Abdulhamid Han Research and Training Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 32694180 BACKGROUND

• 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.

  PMID: 34849428 BACKGROUND

• 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.

  PMID: 33987289 BACKGROUND

• 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.

  PMID: 31613690 BACKGROUND

• 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.

  PMID: 30943978 BACKGROUND

• 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.

  PMID: 31378412 BACKGROUND

• 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.

  PMID: 30545350 RESULT

Related Links

• KOAH alevlenme ile acil servis'e başvuran hastalarda, spirometrik ölçümler, ciddiyet skorları ve laboratuvar parametrelerinin prognozu öngörmedeki değeri

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Erdem Cevik, MD

CONTACT

+905054515930; cevikerdem@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 18, 2022
• Study Start: August 1, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 25, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)