Clinical trial NCT06561464: Evaluation of Oxygen Delivery Methods in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Official title: Reflections of Oxygen Delivery Methods Applied in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) on Blood Gas and Spirometer Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Exacerbation
Keywords: Non-invasive ventilation
EzPAP®
Respiratory Failure
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Arterial blood gas and spirometry values will be examined before and after treatment administration to patients.
timeFrame: 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.
measure: Evaluation of the patient's mortalite after treatment.
timeFrame: The 30-day mortality of the patients will be evaluated.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
Study officials:
affiliation: Ankara Etlik City Hospital
name: Ahmet Burak Erdem
role: STUDY_DIRECTOR
References:
citation: Iberl G, Bornitz F, Schellenberg M, Wiebel M, Herth FJ, Kreuter M. [Respiratory therapy with Ez-PAP for treatment of dynamic hyperinflation in patients with severe COPD and emphysema]. Pneumologie. 2014 Sep;68(9):604-12. doi: 10.1055/s-0034-1377483. Epub 2014 Sep 9. German.
citation: Rieg AD, Stoppe C, Rossaint R, Coburn M, Hein M, Schalte G. [EzPAP(R) therapy of postoperative hypoxemia in the recovery room : experiences with the new compact system of end-expiratory positive airway pressure]. Anaesthesist. 2012 Oct;61(10):867-74. doi: 10.1007/s00101-012-2083-4. Epub 2012 Sep 27. German.