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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Exacerbation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

EzPAP®

Intervention Type 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 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

Group Type ACTIVE_COMPARATOR

Non-invasive mechanical ventilation (NIMV)

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes