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

Ankara Etlik City Hospital

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease Exacerbation

Treatments: Device: Non-invasive mechanical ventilation (NIMV); Device: EzPAP®

Study type: Interventional

Funder types: Other

Identifiers

NCT06561464

ES-COPD

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group A: EzPAP® will be applied

Active Comparator group

Description:

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

Treatment:

Device: EzPAP®

Group B: NIMV will be applied.

Active Comparator group

Description:

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

Treatment:

Device: Non-invasive mechanical ventilation (NIMV)