Evaluation of the Efficacy of Different Nebulization Techniques

August 17, 2022 updated by: Erdem Cevik, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Sultan Abdülhamid Han Research and Training Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Vibrating MESH nebulizer
Medication will be applied with Vibrating MESH nebulizer
Device: Vibrating MESH nebulizer (Aerogen Ultra)
Medication will be applied with Vibrating MESH nebulizer
ACTIVE_COMPARATOR: Jet nebulizers
Medication will be applied with Jet nebulizers
Device: Jet nebulizers (Philips Respironics)
Medication will be applied with Jet nebulizers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of spirometric measurement
Time Frame: Change from pretreatment spirometric measurements at first hour.
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)
Time Frame: 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
Change from pretreatment IPI at first hour.
VAS score change of dyspnea
Time Frame: Change from pretreatment VAS score at first hour.
0 is no dyspnea and 10 is the biggest dyspnea attacks
Change from pretreatment VAS score at first hour.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nebulization time
Time Frame: Measured with each nebulization treatment at first hour
time from start to end of nebulization treatment will measured in minutes
Measured with each nebulization treatment at first hour
patient satisfaction
Time Frame: Measured after each nebulization application at first hour.
Satisfaction of nebulization treatment ( 5 Lincert scale)
Measured after each nebulization application at first hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2022

Primary Completion (ANTICIPATED)

September 15, 2022

Study Completion (ANTICIPATED)

September 25, 2022

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (ACTUAL)

August 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ecevik1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol will be shared but Our clinical datas' are not available for sharig considering ethical problems.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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