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

Reflections of Oxygen Delivery Methods Applied in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) on Blood Gas and Spirometer Measurements

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease Exacerbation
• Intervention / Treatment: Device: EzPAP®; Device: Non-invasive mechanical ventilation (NIMV)

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 38000
      • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: EzPAP® will be applied; 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); Moderate to severe dyspnea leading to the use of accessory respiratory muscles and paradoxical abdominal movements,; Tachypnea (respiratory rate > 25 breaths per minute),; Arterial blood gas (ABG) results with pH < 7.35, pCO2 > 45 mmHg, or; PaO2/FiO2 < 200 mmHg	Device: EzPAP®; 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.
Active Comparator: Group B: NIMV will be applied.; 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); Moderate to severe dyspnea leading to the use of accessory respiratory muscles and paradoxical abdominal movements,; Tachypnea (respiratory rate > 25 breaths per minute),; Arterial blood gas (ABG) results with pH < 7.35, pCO2 > 45 mmHg, or; PaO2/FiO2 < 200 mmHg	Device: Non-invasive mechanical ventilation (NIMV); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.; Before treatment, the following parameters will be assessed:Blood pressure (mmHg)Oxygen Saturation (%)Respiratory rate /min,Heart rate/minpHpCO2-mmHgPaO2-mmHgHCO3-mEq/LLactate-mmol/LFEV1-LiterFVC-Liter- PEF-L/min; After treatment, the following parameters will be assessed:Blood pressure (mmHg)Oxygen Saturation (%)Respiratory rate /min,Heart rate/minpHpCO2-mmHgPaO2-mmHgHCO3-mEq/LLactate-mmol/LFEV1-LiterFVC-LiterPEF-L/min	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.

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital
• Investigators: Study Director: Ahmet Burak Erdem, Ankara Etlik City Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Non-invasive ventilation; Respiratory Failure; EzPAP®
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Disease Progression; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ES-COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A decision will be made after the study is written up as an article.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No