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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease Exacerbation
• Interventions: Device: Non-invasive mechanical ventilation (NIMV); Device: EzPAP®

• Registration Number: NCT06561464
• Lead Sponsor: Ankara Etlik City Hospital

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.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-06-01
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-20
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-29
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: NIMV will be applied.	Non-invasive mechanical ventilation (NIMV)	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
Group A: EzPAP® will be applied	EzPAP®	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

Primary Outcome Measures

Name	Time	Method
Arterial blood gas and spirometry values will be examined before and after treatment administration to patients.	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.	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
Evaluation of the patient's mortalite after treatment.	The 30-day mortality of the patients will be evaluated.	- 30-day mortality of the patients will be evaluated.

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey