a. To determine what proportion of COPD patients demonstrate EFL during NIV useb. To determine the range of EPAP necessary to overcome EFLc. To determine longitudinal change of EFL with time and interaction with exacerbationd. To describe the…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall Prevalence of EFL in Ventilated hypercapnic COPD patients, as defined
as the percentage participants exhibiting a DeltaXrs value greater than or
equal to 2.8 at study initiation and at 6 months post therapy.
Secondary outcome
Descriptive outcomes with respect to:
- the range of EPAP necessary to overcome EFL
- longitudinal change of EFL with time and preceding an COPD exacerbation
- the phenotypic characteristics of COPD most associated with nocturnal EFL
- Effect of EFL-titrated NIV on quality of life, dyspnea, arterial blood gases,
exercise tolerance, patient comfort, lung function, ventilatory efficacy and
patient-ventilator asynchrony, patient effort, and lung inflation.
Background summary
A key physiologic feature of chronic obstructive pulmonary disease is
expiratory flow limitation 1, which occurs because of loss of elastic recoil in
turn arising from alveolar damage. This commonly occurs when sufficiently
severe gas trapping occurs leading to hyperinflation. By placing the patient
on an unfavorable portion of the pressure-volume curve, such patients become
harder to ventilate and may experience more side effects, as a consequence.
Study objective
a. To determine what proportion of COPD patients demonstrate EFL during NIV
use
b. To determine the range of EPAP necessary to overcome EFL
c. To determine longitudinal change of EFL with time and interaction with
exacerbation
d. To describe the phenotypic characteristics of COPD most associated with
nocturnal EFL
e. To determine physiological and clinical effects of EFL-titrated NIV
Study design
Prospective six-month observational multicenter registry study
Intervention
EFL-titrated NIV with the A40 machine
Study burden and risks
The risk benefit analysis for the A40 EFL should be considered in comparison to
the standard of care which would be the A40 (or equivalent device from another
manufacturer). In that context the proposed benefits of the A40 EFL are more
efficient ventilation which should be manifest as better adherence because of
improved comfort, and/or better control of hypercapnia.
The EFL mode is anticipated to expose the patients to higher levels of EPAP.
Since NIV devices may have an increased risk for aspiration of gastric
contents, increase in symptoms of sinusitis or otitis media, and decrease in
blood pressure due to a decrease in cardiac output, it is conceptually possible
the risks of these events may be increased. However these are thought to be
minimal risks of using the EFL mode. Furthermore, patients with known heart
failure are excluded. Theoretically, initiation period could be longer (or
shorter) because a new mode has to be initiated. Patients currently on NIV may
find BiPAP A-40 EFL to be less comfortable than their previous NIV, but this is
not a real medical risk, since they can revert to their prior device. Should
side effects occur during the course of the study, they will be recorded,
allowing quantification of the risk for future product use. Significant
adverse events will be reported to the local Research Ethics Committee.
Participation in the trial does not lead to additional visits compared to
regular care. The following additional tests will be performed:
- a urine pregnancy test for woman in the childbearing age
- the mMRC dyspnea scoring list and the COPD assessment test at baseline and at
6 months
- a 6-minute waking test at baseline and at 6 months
- EFL titration at baseline and at 6 months
- a HRCT at baseline and at 6 months
- non-invasive measurements of respiratory muscle activity and lung inflation
during the admission and follow-up.
Golden Mile Highway 1
Monroeville 1740
US
Golden Mile Highway 1
Monroeville 1740
US
Listed location countries
Age
Inclusion criteria
COPD (FEV1 <60% predicted and FEV1/VC < 0.7)
Age > 40 years
Chronic hypercapnia (daytime PaCO2 > 6.0 kPa)
No Clinical diagnosis of OSA
Smoking history > 10 pack year
BMI <= 35kg/m2
Exclusion criteria
Hypercapnic respiratory acidosis defined as pH <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
Pregnant
CHF with EF less than 45% determined by Echo if available
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ClinicalTrials.gov: NCT04419428 |
| CCMO | NL75723.042.22 |