Comparison of Bronchodilator Treatment Practices in Group E COPD Patients

COPD Exacerbation Acute Clinical Trial

Official title:

Comparison of Bronchodilator Treatment Practices in Group E COPD Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06178068
• Other study ID #: B.30.2.ATA.0.01.00/122
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: January 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD Exacerbation Acute

Intervention

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® EHSIM 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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