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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: EzPAP® will be applied | Active Comparator | This group, selected randomly and allocated to non-invasive ventilation (NIV) indication, will receive EzPAP® as a single-blind randomized trial. Non-Invasive Indications for Acute Exacerbations of COPD: (At least two of the following parameters must be present)
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| Group B: NIMV will be applied. | Active Comparator | This group, selected randomly and allocated to non-invasive ventilation (NIMV) as a single-blind randomized trial, NIMV provides respiratory support during both expiration and inspiration with either continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP), which operates with intermittent positive pressure. Non-Invasive Indications for Acute Exacerbations of COPD: (At least two of the following parameters must be present)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 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. | The 30-day mortality of the patients will be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Burak Erdem | Ankara Etlik City Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Ankara | Yenimahalle | 38000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25203820 | Background | 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. | |
| 23011043 | Background | 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. |
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A decision will be made after the study is written up as an article.
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| 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 |
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| 40596843 | Derived | Sarcan E, Erdem AB, Yazla M, Uysal SB, Celikel E. Comparison of positive expiratory pressure device versus non-invasive ventilation on outcomes in acute exacerbation of chronic obstructive pulmonary disease in the emergency department. BMC Emerg Med. 2025 Jul 1;25(1):110. doi: 10.1186/s12873-025-01267-z. |