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NCT Number: NCT06561464

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

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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Key information

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, Yenimahalle, 38000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Arterial blood gas and spirometry values will be examined before and after treatment administration to patients.

    Time frame: 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.

    • 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
    • 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

  2. Evaluation of the patient's mortalite after treatment.

    Time frame: The 30-day mortality of the patients will be evaluated.

    • 30-day mortality of the patients will be evaluated.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Reflections of Oxygen Delivery Methods Applied in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) on Blood Gas and Spirometer Measurements

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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