Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Randomised Controlled Trial of Home Mechanical Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease Patients Post Acute Hypercapnic Exacerbation
This study is designed to investigate the effect of home mechanical ventilation (HMV) in patients with severe chronic obstructive pulmonary disease (COPD). The purpose of the trial is to test the hypothesis that HMV and longterm oxygen therapy (LTOT) increases admission free survival compared with LTOT alone. More specifically, compared with LTOT, HMV and LTOT reduces hospital re-admission in COPD patients who remain persistently hypercapnic following an acute exacerbation requiring non-invasive ventilation (NIV).
Status | Completed |
Enrollment | 116 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with COPD - Acute hypercapnic exacerbation of COPD at least 2 weeks previously - Tolerated non-invasive ventilation during acute hypercapnic exacerbation - Chronic hypoxia requiring LTOT (PaO2 <7.3kPa or a PaO2 >7.3 and <8.0kPa and one of the following: secondary polycythaemia; nocturnal hypoxaemia SaO2 <90% for >30% of the time; peripheral oedema; or PHT) - Chronic hypercapnia (PaCO2 >7kPa) - =20 pack year smoking history - FEV1/FVC <60% - FEV1 at <50% predicted Exclusion Criteria: - Persistent hypercapnic respiratory failure with acidosis (defined as pH <7.30 after bronchodilators) - Development of worsening hypercapnic respiratory failure with acidosis during initiation of LTOT therapy - Failure to tolerate NIV during the acute illness preceding trial identification - Post extubation or decannulation following AHRF requiring intubation - Restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the FEV1/FVC ratio is <60% and the FEV1 <50% if the predominant defect is considered to be obstructive by the center clinician. - Clinical features of severe OSA - BMI >35kg/m2 - Unstable coronary artery syndrome - Cognitive impairment that would prevent informed consent into the trial - Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge - Patients undergoing renal replacement therapy - Age <18 years - Pregnant - Inability to comply with the protocol |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Papworth Hospital | Cambridge | |
United Kingdom | St James' University Hospital | Leeds | |
United Kingdom | Guy's & St Thomas' NHS Foundation Trust | London | |
United Kingdom | King's College Hospital | London | |
United Kingdom | Royal Brompton & Harefield NHS Foundation Trust | London | |
United Kingdom | Royal Free Hospital / University College London | London | |
United Kingdom | John Radcliffe Hopsital | Oxford |
Lead Sponsor | Collaborator |
---|---|
Patrick Murphy | Guy's & St Thomas' Charity, ResMed, ResMed Foundation, Respironics International |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days from trial intervention to either hospital admission or death | 1 year | No | |
Secondary | Spirometry - specifically FEV1 & FVC change from trial intervention to follow up. | 1 year | No | |
Secondary | Changes Health related quality of life from pre-intervention to follow up - specifically outcomes of severe respiratory insufficiency questionnaire, chronic respiratory disease questionnaire & MRC dyspnoea score | 1 year | No | |
Secondary | Change in arterial PaCO2 from pre-intervention to follow up | 1 year | No | |
Secondary | Change in the incremental shuttle walk test from pre-intervention to follow up | 1 year | No | |
Secondary | Frequency of acute exacerbations of COPD requiring addition of antibiotics and or steroids and or hospital admission | 1 year | No |
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