|- candidate number||2768|
|- NTR Number||NTR1100|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-sep-2007|
|- Secondary IDs||2007/160 |
|- Public Title||REspiratory Support in COPD after acUte Exacerbation.|
|- Scientific Title||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).|
|- hypothesis||Does chronic nocturnal ventilatory support at home after acute respiratory failure treated by (N)IV lead to a prolongation in time to readmission to hospital due to any following exacerbations in these patients compared to medical treatment only.|
|- Healt Condition(s) or Problem(s) studied||COPD, Respiratory failure|
|- 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 =>75 years; |
2. Significant bronchiectasis with recurrent infections;
3. Significant heart failure;
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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2007|
|- planned closingdate||1-nov-2009|
|- Target number of participants||200|
|- Interventions||The intervention group will receive non-invasive ventilatory support at night at home as well as medical treatment, and the control group will receive standard medical treatment only for the duration of 1 year. |
|- Primary outcome||Time to event is the primary study outcome, for which an event is defined as a readmission to hospital due to an exacerbation or death.|
|- Secondary outcome||1. Exacerbations;|
2. Health related quality of life;
3. Total readmission rate;
4. Total event rate;
6. Medical costs;
8. Activities of daily living;
9. Exercise tolerance;
10. Blood gasses PaO2 and PaCo2;
11. Lung function;
12. Inflammation (systemic) markers*;
13. Muscle strength*;
14. Nutritional status*;
* if possible in specialised centres.
|- Timepoints||Baseline, 3, 6 and 12 months.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. F.M. Struik|
|- CONTACT for SCIENTIFIC QUERIES||Drs. F.M. Struik|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department of Pulmonology|
(Source(s) of Monetary or Material Support)
|Longfonds The Netherlands |
|- Brief summary||Rationale: Currently, chronic ventilatory support for patients with neuromuscular disease and kyphoscoliosis in the Netherlands is routinely managed by 4 home mechanical ventilation (HMV) centres. In contrast, there is no consensus yet how to treat patients with COPD with chronic respiratory failure after an acute event, due to the lack of studies in this area. However, some patients in the Netherlands do receive chronic non invasive ventilation (NIV) after an acute event, while no evidence is available about its effect in the Netherlands or elsewhere. This is the reason why we want to investigate if chronic nocturnal NIV at home is effective in unstable patients with COPD, who remain hypercapnic after ventilatory support during acute respiratory failure. |
Objective: The objective of this study is to investigate if chronic nocturnal ventilatory support at home after acute respiratory failure treated by ventilatory support either invasively or non-invasively leads to a prolongation in time to readmission to hospital for an acute exacerbation, improves quality of life, survival and cost-effectiveness in these patients compared to medical treatment only.
Study design: The protocol concerns a multi-centre, prospective, randomized, controlled study.
Study population: The study will be done in patients with Chronic Obstructive Pulmonary Disease (COPD) who remain hypercapnic after an exacerbation with acute respiratory failure treated in hospital by ventilatory support either invasively or non-invasively.
Intervention: It will take 2 years to include all 200 patients from which 100 will receive non-invasive ventilatory support at night at home as well as medical treatment, and 100 comprise the control group who will receive medical treatment only, for the duration of 1 year.
Main study parameters/endpoints: Primary study parameter: time to readmission. Secondary parameters; health related quality of life, readmission rate, survival, medical costs, dyspnoea, ADL, exercise tolerance, blood gasses, lung function, muscle strength, nutritional status.
|- Main changes (audit trail)|
|- RECORD||25-sep-2007 - 30-jun-2012|