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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06561464
Enrollment
100
Registered
2024-08-20
Start date
2023-11-01
Completion date
2024-06-01
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation

Keywords

Non-invasive ventilation, EzPAP®, Respiratory Failure

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.

Interventions

DEVICEEzPAP®

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.

DEVICENon-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

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026