Comparison of Bronchodilator Treatment Practices in Group E COPD Patients

NCT06178068 | Unknown

• 1 other identifier: B.30.2.ATA.0.01.00/122
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COPD Exacerbation Acute

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Group 1; jet nebulizer group

ACTIVE COMPARATOR

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

Group 2; dry air nebulizer group

ACTIVE COMPARATOR

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

Group 3; Classic nebülizer group

ACTIVE COMPARATOR

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

Interventions

Comparison of bronchodilator effectiveness of nebulizer therapy devices DEVICE

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.

Group 1; jet nebulizer group; Group 2; dry air nebulizer group; Group 3; Classic nebülizer group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group E COPD patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 20, 2023
• Study Start: January 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-12