A40 EFL Registry: A Multicenter Prospective Study to Determine the Role of EFL in Patients with Chronic Obstructive Pulmonary Disease (COPD) Receiving Home Mechanical Ventilation Protocol ID: SRC_HRC_VectorEURegistry_2019_10820

Phase 4

• Conditions: COPD; emphysema; 10006436

• Registration Number: NL-OMON56616
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Overall Prevalence of EFL in Ventilated hypercapnic COPD patients, as defined<br /><br>as the percentage participants exhibiting a DeltaXrs value greater than or<br /><br>equal to 2.8 at study initiation and at 6 months post therapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Descriptive outcomes with respect to:<br /><br>- the range of EPAP necessary to overcome EFL<br /><br>- longitudinal change of EFL with time and preceding an COPD exacerbation<br /><br>- the phenotypic characteristics of COPD most associated with nocturnal EFL<br /><br>- Effect of EFL-titrated NIV on quality of life, dyspnea, arterial blood gases,<br /><br>exercise tolerance, patient comfort, lung function, ventilatory efficacy and<br /><br>patient-ventilator asynchrony, patient effort, and lung inflation. </p><br>