Status:
COMPLETED
Home Mechanical Ventilation vs Home Oxygen Therapy in COPD
Lead Sponsor:
Patrick Murphy
Collaborating Sponsors:
Guy's & St Thomas' Charity
Respironics International
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 hypo...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00990132
Start Date
October 1 2009
End Date
April 1 2016
Last Update
May 13 2016
Active Locations (7)
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1
Papworth Hospital
Cambridge, United Kingdom
2
St James' University Hospital
Leeds, United Kingdom
3
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
4
King's College Hospital
London, United Kingdom