Home Mechanical Ventilation vs Home Oxygen Therapy in COPD
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|ClinicalTrials.gov Identifier: NCT00990132|
Recruitment Status : Completed
First Posted : October 6, 2009
Last Update Posted : May 13, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Device: Home mechanical ventilation Device: Long term oxygen therapy||Phase 2 Phase 3|
Although HMV has been shown to improve physiological parameters as well as have clinical benefits in terms of dyspnoea and exercise capacity in severe COPD, the published randomised controlled trials have been less positive. The Steering Committee are committed to design a robust clinical trial that will answer this clinical question. Therefore, a multi-centre randomised controlled trial has been designed with recruitment and power calculations based on the applicants own data.
We will recruit from 8 UK university centres with expertise in HMV, 116 hypercapnic patients (58 in each arm) with persistent hypercapnia following an episode of acute hypercapnic respiratory failure. During the acute hypercapnic episode the patient would have be eligible for non-invasive ventilation with a pH <7.35 and a partial pressure of carbon dioxide (PaCO2) > 7.0kPa. They will be randomised, for a 12 months, to either
- HMV and LTOT (Treatment Group)
LTOT alone (Control Group) This study would allow the investigators to answer a number of questions pertaining to clinical efficacy of HMV in COPD as well as the mechanism of action of HMV in COPD
- Does HMV effect admission-free survival?
- Does HMV reduce exacerbation frequency?
- Does HMV impact on disease progression?
- Does HMV improve health-related quality of life?
- Does HMV improve exercise capacity?
- Is there a dose-response between hours of ventilator compliance and daytime PaO2 and PaCO2?
- Do patients increase hours of ventilator use during acute exacerbations?
- Is ventilator compliance with HMV and LTOT acceptable?
- Does HMV reduce healthcare utilisation? Follow-up assessments will be performed at 6 weeks, 3, 6 and 12 months. These data collected will include admission-free survival (primary outcome), hours of compliance with HMV, HRQL, gas exchange, lung function, body composition, exercise capacity, exacerbation frequency primary care consultations and compliance with LTOT, time to withdrawal of LTOT/night-time oxygen therapy based on daytime PaO2 and overnight SaO2 (secondary outcome measures). The relation of any changes to factors predicting severity of COPD will be studied. The cost effectiveness and cost-utility analysis of HMV will be studied.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Controlled Trial of Home Mechanical Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease Patients Post Acute Hypercapnic Exacerbation|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Active Comparator: Long term oxygen therapy
LTOT will be established as per current national guidelines
Device: Long term oxygen therapy
LTOT established as per national guidelines
Experimental: Home mechanical ventilation
Patients will be set up on LTOT as per national guidelines and nocturnal non-invasive ventilation in accordance with study protocol.
Device: Home mechanical ventilation
Nocturnal non-invasive ventilation
- Days from trial intervention to either hospital admission or death [ Time Frame: 1 year ]
- Spirometry - specifically FEV1 & FVC change from trial intervention to follow up. [ Time Frame: 1 year ]
- 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 [ Time Frame: 1 year ]
- Change in arterial PaCO2 from pre-intervention to follow up [ Time Frame: 1 year ]
- Change in the incremental shuttle walk test from pre-intervention to follow up [ Time Frame: 1 year ]
- Frequency of acute exacerbations of COPD requiring addition of antibiotics and or steroids and or hospital admission [ Time Frame: 1 year ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- Inability to comply with the protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990132
|Cambridge, United Kingdom|
|St James' University Hospital|
|Leeds, United Kingdom|
|Guy's & St Thomas' NHS Foundation Trust|
|London, United Kingdom, SE1 7EH|
|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, United Kingdom|
|Principal Investigator:||Patrick Murphy, MBBS||Guy's and St Thomas' NHS Foundation Trust|
|Study Chair:||Nicholas Hart, PhD||Guy's and St Thomas' NHS Foundation Trust|
|Responsible Party:||Patrick Murphy, PI, Guy's and St Thomas' NHS Foundation Trust|
|Other Study ID Numbers:||
|First Posted:||October 6, 2009 Key Record Dates|
|Last Update Posted:||May 13, 2016|
|Last Verified:||May 2016|
Home mechanical ventilation
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases