The effect of chronic nocturnal non-invasive ventilatory support at home after ventilatory support during acute respiratory failure in patients with Chronic Obstructive Pulmonary Disease (COPD).

Completed

Conditions: Chronic bronchitis
COPD
10038716

Registration Number: NL-OMON31750

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

1) Chronic Obstructive pulmonary disease (COPD), GOLD severity stage 3 and 4.
2) Minimally 48 hours without ventilatory support after invasive or non invasive ventilatory support during an acute respiratory failure and maximally until discharge.
3) Persistent hypercapnia (PaCO2 > 6.0 kPa) during daytime at rest without ventilatory support.

Exclusion Criteria

1) Age < 18 or =>80 years
2) Significant bronchiectasis with recurrent infections
3) Significant heart failure
4) Kyphoscoliosis
5) Neuromuscular disease
6) Obstructive sleep apnea (Apnea Hypopnea Index: AHI >15 /hr)
7) Current use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP)
8) Insufficient motivation for chronic ventilatory support;
9) Social circumstances making chronic ventilatory support impossible;
10) Other disease factors limiting life expectations

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Time to event is the primary study outcome, for which an event is defined as a<br /><br>readmission to hospital due to an exacerbation or death. An exacerbation is<br /><br>defined using a modified version of the definition of Rodriguez-Roisin, as an<br /><br>event in the natural course of the disease defined as characterized by a change<br /><br>in the patient*s baseline dyspnoea, cough, and/or sputum that is beyond<br /><br>day-to-day variations, is acute in onset, and which is treated with an<br /><br>antibiotics course and/or prednisolon in patients with underlying COPD.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Exacerbations<br /><br>- Health related quality of life<br /><br>- Total readmission rate<br /><br>- Total event rate<br /><br>- Survival<br /><br>- Medical costs<br /><br>- Dyspnoea<br /><br>- Activities of daily living<br /><br>- Blood gasses PaO2 and PaCo2<br /><br>- Inflammation (systemic) markers<br /><br>- Lung function<br /><br>- Muscle strength<br /><br>- Nutritional status</p><br>