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

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 - A40 EFL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56616

Enrollment

Registered

2022-08-26

Start date

2022-10-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD emphysema

Interventions

EFL-titrated NIV with the A40 machine

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: COPD (FEV1 40 years Chronic hypercapnia (daytime PaCO2 > 6.0 kPa) No Clinical diagnosis of OSA Smoking history > 10 pack year BMI

Exclusion criteria

Exclusion criteria: Hypercapnic respiratory acidosis defined as pH

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)