Status:
WITHDRAWN
A40 Expiratory Flow Limitation Registry
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-85 years
Brief Summary
This prospective observational multicenter registry study will include adults greater than 40 years old, diagnosed with chronic obstructive pulmonary disease, requiring home noninvasive ventilation as...
Detailed Description
Prospective observational multicenter registry study for chronic obstructive pulmonary disease patients who require noninvasive ventilation in the home setting as part of standard medical care. The re...
Eligibility Criteria
Inclusion
- Chronic Obstructive Pulmonary Disease
- Forced Expiratory Volume (FEV1) \< 60% predicted
- Forced Expiratory Volume (FEV1) / Vital Capacity (VC) ratio \< 0.7
- Greater than 40 years old
- Chronic hypercapnia (daytime carbon dioxide level PaCO2 \> 6.0 kPa)
- No clinical diagnosis of Obstructive Sleep Apnea
- Smoking history \> 10 pack year
- Body mass index (BMI) ≤ 35kg/m2
Exclusion
- Hypercapnic respiratory acidosis defined as pH (measure of hydrogen ion, measure of the acidity or alkalinity of a fluid) \<7.35
- Acute coronary syndrome and unstable angina
- Cognitive impairment that would prevent informed consent into the trial and/or inability to comply with the protocol
- Patients undergoing renal replacement therapy
- Patients with serious comorbidities confirming prognosis likely to be less than 12-months
- Pregnancy
- Congestive Heart Failure (CHF) with ejection fraction (EF) less than 45% determined by Echo if available
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04419428
Start Date
February 1 2024
End Date
September 1 2025
Last Update
January 19 2024
Active Locations (1)
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1
Royal Brompton Hospital
London, United Kingdom, SW3 6NP