Comparison of Bronchodilator Treatment Practices in Group E COPD Patients

COPD is a heterogeneous condition caused by airway (bronchitis/bronchiolitis) or alveolar (emphysema) abnormality, changes with chronic respiratory changes (dyspnea, dyspnoea, phlegm). It is characterized by persistent and frequently progressive airway obstruction. In COPD, which progresses with high mortality, non-pharmacological treatments are applied, as well as pharmacological treatments. They have an essential place in slowing down the progressive course of this treatment. However, despite the treatment administered to COPD patients, outdoor weather conditions, improper use of inhaler treatments, or comorbidities may cause acute exacerbation of COPD.

Dry air nebulizer devices use dry air from the central system in hospitals. This system, which converts bronchodilator drugs into nebulizers by creating high currents, works like classical nebulizers without an electrical system and can have a higher flow rate than jet nebulizer devices. This procedure, which can be applied to COPD patients without giving high-flow oxygen, prevents carbon dioxide retention. There is no study in the literature comparing the bronchodilator effectiveness of dry air, classical nebulizer, and jet nebulizer, and the investigators aimed to compare the efficacy of these three treatment modalities in our study.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD Exacerbation Acute
• Intervention / Treatment: Device: Comparison of bronchodilator effectiveness of nebulizer therapy devices

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Group E COPD patients

Exclusion Criteria:

• Recent MI
• Pulmonary embolism
• Cerebral aneurysm
• Active hemoptysis
• Pneumothorax
• Nausea, vomiting
• Recent thorax, abdominal, and eye surgery were identified in the patients before the pulmonary function test and were not included in the study.
• Mental retardation
• Pneumonia with acute exacerbation of COPD
• Patients with pulmonary edema due to congestive heart failure
• Patients with interstitial lung disease along with COPD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; jet nebulizer group; The Respirox® RNEB-18 device was used for the bronchodilator treatment given before the randomization of the patients and for the maintenance bronchodilator treatment given in Group 1 patients. After calibrating the device, it was determined that it performed nebulization with a flow of 6 lt/min.	Device: Comparison of bronchodilator effectiveness of nebulizer therapy devices; The Respirox® RNEB-18 device was used for the bronchodilator treatment given before the randomization of the patients and for the maintenance bronchodilator treatment given in Group 1 patients. After calibrating the device, it was determined that it performed nebulization with a flow of 6 lt/min. In Group 2 patients, a HAVELSAN® EHSİM brand nebulizer produced in our country, compatible with the central system of our hospital, was used as a dry air nebulizer. For classical nebulizer treatment in Group 3 patients, a nebulizer device compatible with our hospital's central oxygen system was used. In Group 2 and 3 patients, the flow system could be adjusted manually. To be consistent with Group 1 patients, bronchodilator treatment was administered at a 6 lt/min flow rate.
Active Comparator: Group 2; dry air nebulizer group; In Group 2 patients, a HAVELSAN® EHSİM brand nebulizer produced in our country, compatible with the central system of our hospital, was used as a dry air nebulizer.	Device: Comparison of bronchodilator effectiveness of nebulizer therapy devices; The Respirox® RNEB-18 device was used for the bronchodilator treatment given before the randomization of the patients and for the maintenance bronchodilator treatment given in Group 1 patients. After calibrating the device, it was determined that it performed nebulization with a flow of 6 lt/min. In Group 2 patients, a HAVELSAN® EHSİM brand nebulizer produced in our country, compatible with the central system of our hospital, was used as a dry air nebulizer. For classical nebulizer treatment in Group 3 patients, a nebulizer device compatible with our hospital's central oxygen system was used. In Group 2 and 3 patients, the flow system could be adjusted manually. To be consistent with Group 1 patients, bronchodilator treatment was administered at a 6 lt/min flow rate.
Active Comparator: Group 3; Classic nebülizer group; For classical nebulizer treatment in Group 3 patients, a nebulizer device compatible with our hospital's central oxygen system was used.	Device: Comparison of bronchodilator effectiveness of nebulizer therapy devices; The Respirox® RNEB-18 device was used for the bronchodilator treatment given before the randomization of the patients and for the maintenance bronchodilator treatment given in Group 1 patients. After calibrating the device, it was determined that it performed nebulization with a flow of 6 lt/min. In Group 2 patients, a HAVELSAN® EHSİM brand nebulizer produced in our country, compatible with the central system of our hospital, was used as a dry air nebulizer. For classical nebulizer treatment in Group 3 patients, a nebulizer device compatible with our hospital's central oxygen system was used. In Group 2 and 3 patients, the flow system could be adjusted manually. To be consistent with Group 1 patients, bronchodilator treatment was administered at a 6 lt/min flow rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the change in respiratory function test parameters after 5 days of nebulizer treatment applications.randomization on respiratory function tests	Measurement of % change in FVC, FEV1, RV, TLC level	5 days
Evaluation of the change in arterial blood gas parameters after 5 days of nebulizer treatment applications.randomization on respiratory function tests	Saturation %, measurement of change in partial oxygen and partial carbon dioxide levels in mm_Hg	5 days

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Estimated): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Bronchodilator Agents
• Other Study ID Numbers: B.30.2.ATA.0.01.00/122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No