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Treatment of chronic Respiratory failure in COPD patients with non-invasive ventilation: starting at home and selecting the right patient

Treatment of chronic Respiratory failure in COPD patients with non-invasive ventilation: starting at home and selecting the right patient - Initiation of long-term non-invasive ventilation in COPD.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43384
Enrollment
62
Registered
2016-04-11
Start date
2016-06-09
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Lung emphysema

Interventions

Home initiation of long-term non-invasive ventilation in COPD patients with CHRF

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Indication to initiate chronic NIV in COPD patients (GOLD stage III or IV: FEV1/ FVC 6.0 kPa in stable condition, which means no COPD exacerbation for 4 weeks and a pH > 7.35) - Age > 18 years - Existence of a sufficient social support network making initiation of HMV at home possible and safe. - Written informed consent is obtained

Exclusion criteria

Exclusion criteria: - Instable severe cardiac comorbidities (left ventricular ejection fraction below 45%, instable angina pectoris complaints) - Patients admitted to a nursing home

Design outcomes

Primary

MeasureTime frame
Non-inferiority of home initiation of NIV will be assesed in terms of improvement in PaCO2 (at daytime without NIV or additional oxygen) after 6 months.—

Secondary

MeasureTime frame
Secondary outcomes are change in lung function (forced expiratory volume in 1 second (FEV1), lung volumes (total lung capacity (TLC), residual volume (RV) and RV%TLC), and diffusion capacity (DLCO (%predicted)), change in HRQoL, compliance, exercise tolerance and costs including cost-effectiveness analyses—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)