Evaluation of Oxygen Delivery Methods in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Ankara Etlik City Hospital100 enrolled

Overview

To examine the effects of oxygen therapy methods applied as indicated in COPD acute exacerbations on blood gas results and spirometric measurements.

Patients requiring non-invasive ventilation will be divided into two groups: one group will receive NIMV in the form of Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP). The other group will receive EzPAP® (a non-invasive positive airway pressure device). For both groups, blood gas results and hand-held spirometer parameters, including Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), and Forced Expiratory Volume in one second (FEV1), will be evaluated before and after the application.It is aimed to evaluate the effect of COPD noninvasive treatment methods on hospitalization and mortality processes.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation

Interventions

EzPAP®DEVICE

EzPAP® is a portable, single-use respiratory exercise device that provides positive expiratory pressure during expiration while supporting respiration during inspiration. Its use has been increasing in recent years as an oxygenation device. It is portable, single-use, easy to use, well-tolerated, and cost-effective. EzPAP® helps increase functional capacity in the lungs and reduces atelectasis. With EzPAP®, an oxygen flow of 5-8 L/min reaches the patient as 35-42% fractionated oxygen, thus quadrupling the oxygen flow.

Non-invasive mechanical ventilation (NIMV)DEVICE

NIMV provides respiratory support during both expiration and inspiration through continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP). Treatment success can be monitored within the first 2 hours by the improvement in oxygenation and reduction in pCO2 levels

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with acute exacerbation of COPD, * Those without a history of trauma, * Patients who have not undergone any lung surgery previously, * Patients capable of providing written and verbal consent. Exclusion Criteria: * Patients without acute exacerbation of COPD, * Pregnancy, suspected pregnancy, * Those who have undergone any lung surgery previously, * Patients with a history of trauma, * Intubated patients and those not compliant with treatments, * Patients unable to provide written and verbal consent.

Locations (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Outcomes

Primary Outcomes

Arterial blood gas and spirometry values will be examined before and after treatment administration to patients.

Patients meeting the inclusion criteria will be enrolled in the study after obtaining informed consent. 1. Before treatment, the following parameters will be assessed: * Blood pressure (mmHg) * Oxygen Saturation (%) * Respiratory rate /min, * Heart rate/min * pH * pCO2-mmHg * PaO2-mmHg * HCO3-mEq/L * Lactate-mmol/L * FEV1-Liter * FVC-Liter * \- PEF-L/min 2. After treatment, the following parameters will be assessed: * Blood pressure (mmHg) * Oxygen Saturation (%) * Respiratory rate /min, * Heart rate/min * pH * pCO2-mmHg * PaO2-mmHg * HCO3-mEq/L * Lactate-mmol/L * FEV1-Liter * FVC-Liter * PEF-L/min

Time frame: Patients will receive 2-hour treatment (EzPAP and NIMV) and then measurements will be taken 30 minutes after the completion of treatment in both groups.

Evaluation of the patient's mortalite after treatment.

\- 30-day mortality of the patients will be evaluated.

Time frame: The 30-day mortality of the patients will be evaluated.

Data from ClinicalTrials.gov

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