Chronic Obstructive Pulmonary Disease ExacerbationNCT06561464
Evaluation of Oxygen Delivery Methods in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
A study testing EzPAP® and Non-invasive mechanical ventilation (NIMV) in people with Chronic Obstructive Pulmonary Disease Exacerbation, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
To examine the effects of oxygen therapy methods applied as indicated in COPD acute exacerbations on blood gas results and spirometric measurements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Exacerbation
- What is being tested?
- EzPAP® and Non-invasive mechanical ventilation (NIMV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 38000
About this study
Official title: Reflections of Oxygen Delivery Methods Applied in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) on Blood Gas and Spirometer Measurements
To examine the effects of oxygen therapy methods applied as indicated in COPD acute exacerbations on blood gas results and spirometric measurements.
Read the 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.
- Being tested
- EzPAP®, Non-invasive mechanical ventilation (NIMV)
- Keywords
- Non-invasive ventilation, EzPAP®, Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Group A: EzPAP® will be applied | Active comparator | 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 Receives: Device: EzPAP® |
| Group B: NIMV will be applied. | Active comparator | 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 Receives: Device: Non-invasive mechanical ventilation (NIMV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood gas and spirometry values will be examined before and after treatment administration to patients.
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
Measured: 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.
Evaluation of the patient's mortalite after treatment.
- 30-day mortality of the patients will be evaluated.
Measured: The 30-day mortality of the patients will be evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease ExacerbationStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emine Sarcan, Ankara Etlik City Hospital
- Investigators
- Ahmet Burak Erdem, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561464
- Sponsor's protocol ID
- ES-COPD
- Status last verified
- Sep 2024
- First submitted
- 8 Jul 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A decision will be made after the study is written up as an article.
Publications
Iberl G, Bornitz F, Schellenberg M, Wiebel M, Herth FJ, Kreuter M. [Respiratory therapy with Ez-PAP for treatment of dynamic hyperinflation in patients with severe COPD and emphysema]. Pneumologie. 2014 Sep;68(9):604-12. doi: 10.1055/s-0034-1377483. Epub 2014 Sep 9. German.
PubMed 25203820Rieg AD, Stoppe C, Rossaint R, Coburn M, Hein M, Schalte G. [EzPAP(R) therapy of postoperative hypoxemia in the recovery room : experiences with the new compact system of end-expiratory positive airway pressure]. Anaesthesist. 2012 Oct;61(10):867-74. doi: 10.1007/s00101-012-2083-4. Epub 2012 Sep 27. German.
PubMed 23011043Sarcan E, Erdem AB, Yazla M, Uysal SB, Celikel E. Comparison of positive expiratory pressure device versus non-invasive ventilation on outcomes in acute exacerbation of chronic obstructive pulmonary disease in the emergency department. BMC Emerg Med. 2025 Jul 1;25(1):110. doi: 10.1186/s12873-025-01267-z.
PubMed 40596843
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflections of Oxygen Delivery Methods Applied in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) on Blood Gas and Spirometer Measurements
- ClinicalTrials.gov ID
- NCT06561464
- Acronym / sponsor ID
- ES-COPD
- Keywords
- Non-invasive ventilation, EzPAP®, Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: EzPAP® will be applied | Active comparator | Device: 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 |
| Group B: NIMV will be applied. | Active comparator | Device: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group A: EzPAP® will be applied |
| 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 | Device | Group B: NIMV will be applied. |
Primary outcome
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. 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.
Time frame: The 30-day mortality of the patients will be evaluated.
- 30-day mortality of the patients will be evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 25203820Iberl G, Bornitz F, Schellenberg M, Wiebel M, Herth FJ, Kreuter M. [Respiratory therapy with Ez-PAP for treatment of dynamic hyperinflation in patients with severe COPD and emphysema]. Pneumologie. 2014 Sep;68(9):604-12. doi: 10.1055/s-0034-1377483. Epub 2014 Sep 9. German.
- Background: PubMed 23011043Rieg AD, Stoppe C, Rossaint R, Coburn M, Hein M, Schalte G. [EzPAP(R) therapy of postoperative hypoxemia in the recovery room : experiences with the new compact system of end-expiratory positive airway pressure]. Anaesthesist. 2012 Oct;61(10):867-74. doi: 10.1007/s00101-012-2083-4. Epub 2012 Sep 27. German.
- Derived from this study: PubMed 40596843Sarcan E, Erdem AB, Yazla M, Uysal SB, Celikel E. Comparison of positive expiratory pressure device versus non-invasive ventilation on outcomes in acute exacerbation of chronic obstructive pulmonary disease in the emergency department. BMC Emerg Med. 2025 Jul 1;25(1):110. doi: 10.1186/s12873-025-01267-z.
- Individual participant dataSharing planned: No. A decision will be made after the study is written up as an article.
Related trials for Chronic Obstructive Pulmonary Disease Exacerbation
Active, not recruiting
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Oxygen Deficiency, COPD Exacerbation
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
Chronic Obstructive Pulmonary Disease, COPD Exacerbation
RecruitingObservational study
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
COPD Exacerbation, ICU
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Burak Erdem study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EzPAP® and Non-invasive mechanical ventilation (NIMV) in people with Chronic Obstructive Pulmonary Disease Exacerbation, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561464, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.