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

NCT06561464 | Completed

• 1 other identifier: ES-COPD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation

Keywords

Non-invasive ventilation; EzPAP®; Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• 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

  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.

Study Arms (2)

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) * 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®

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) * 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)

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.

Group A: EzPAP® will be applied

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

Group B: NIMV will be applied.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 38000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 25203820 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.

  PMID: 23011043 BACKGROUND

• 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.

  PMID: 40596843 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ahmet Burak Erdem

  Ankara Etlik City Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: August 20, 2024
• Study Start: November 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)