Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT04263532
Eligibility Criteria:
Inclusion Criteria:
1. Age greater than or equal to 40 years of age; less than or equal to 80 years of age
2. Ability to provide consent
3. Chronic obstructive pulmonary disease (COPD) patients with hypercapnia (as defined as greater than or equal to 52mmHg) who are either current non-invasive ventilation (NIV) users or naïve to NIV
4. On average, use NIV more than 4 hours per night (Current NIV users).
5. Must present with expiratory flow limitation (EFL) via screening of the Vector device at 3 cmH2O
6. Have an EPAP to abolish EFL greater or equal to 6cmH2O
Exclusion Criteria:
1. Any major non-COPD uncontrolled disease or condition, such as congestive heart failure, malignancy, liver or renal insufficiency (that requires current evaluation for liver or renal transplantation or dialysis), amyotrophic lateral sclerosis, or severe stroke, or other condition as deemed appropriate by investigator as determined by review of medical history and / or participant reported medical history
2. Suffering from a COPD exacerbation (Defined as hospital admission, ER/urgent care visit, MD visit with medication change or other intervention deemed to be clinically significant by the investigator at the time of data collection or in the 14 days prior to data collection
3. Self-reported Pregnancy or positive pregnancy test for women of childbearing potential.
4. Employee or family member that is affiliated with Philips
5. Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products
6. Any history of giant bulla (size \>1/3 hemi-thorax)
7. History of pneumothorax \< 6 months
8. Participants currently using a PAP or NIV device at home with a documented EPAP setting on their current device that is greater than the calculated EPAP determined during the therapy session of the screening visit (Current NIV Users).
9. Life expectancy ≤12 months as determined by clinical investigator
10. Low BP: Systolic \<90
11. Recent cranial surgery (i.e, less than 1 year)
12. Impaired swallowing as reported by participant or diagnostic exam
13. Recent upper airway or GI surgery within the past 6 months
14. Unable to be fitted with mask
15. Excessive secretions as reported by clinical investigator/physician assessment, inability to maintain a patent airway or adequately clear secretions, or at risk for aspiration of gastric contents
16. Diagnosed with acute sinusitis or otitis media
17. Epistaxis, causing pulmonary aspiration of blood
18. Existing respiratory failure
19. Participants who are naïve to NIV (Cohort 2) that use the device fewer than 3 out of 7 nights during the second week of the 2-week acclimation period
20. Participants who are naïve to NIV (Cohort 2) that average less than 4 hours of device use during the second week of the 2-week acclimation period
21. Participants who are naïve to NIV (Cohort 2) with an average nightly 90% EPAP pressure during the second week of the 2-week acclimation period that is higher than the titrated EFL EPAP pressure determined at the screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04263532
Study Brief:
Protocol Section:
NCT04263532