Status:
COMPLETED
Non-invasive Ventilation Versus Sham Ventilation in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
United Christian Hospital
Collaborating Sponsors:
Philips Respironics
The Hong Kong Lung Foundation
Conditions:
Hypercapnic Respiratory Failure
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The investigators hypothesize that continuation of non-invasive ventilation (NIV) at home after an episode of acute hypercapnic respiratory failure (AHRF) treated by NIV in COPD patients would reduce ...
Detailed Description
Non-invasive ventilation (NIV) has been shown in randomised controlled trials to improve arterial blood gases, reduce intubation and mortality rates in patients suffering from exacerbations of chronic...
Eligibility Criteria
Inclusion
- COPD patient with AHRF who survives after treatment with NIV and successfully weaned off for at least 48 hours.
- Patients who have been intubated and mechanically ventilated can be included if they have also been treated with NIV in the same hospital admission
- Significant obstructive sleep apnoea ruled out by overnight polysomnography done after successful weaning of NIV (Apnoea-hypopnoea index, AHI, \< 10/hr
- Patients willing to give their written informed consent to participate in the study
- Patients understand that he/she would be randomised into receiving home NIV or sham ventilation
- Patients who are able to use the home pressure support ventilators after a period of acclimatisation and training before discharge from the hospital
Exclusion
- Patients with non-COPD causes of AHRF (e.g. asthma, bronchiectasis or lobar pneumonia, fibrothorax, acute pulmonary oedema, etc)
- Patients who have contraindications to NIV and those who refused or failed NIV during an initial 15-minute acclimatization period
- Active smoker
- An increase of ≥ 15% in FEV1 after inhaled salbutamol (200μg)
- Obstructive sleep apnoea (OSA) with apnoea-hypopnoea index (AHI) of ≥ 10/hr
- Other significant co-morbid conditions that in the investigators' view, would confer an adverse prognosis during the study period, e.g., congestive heart failure, uncontrolled diabetes mellitus, tuberculosis, neoplasms, peripheral vascular disease threatening organ functions
- Adverse psycho-social circumstances not conducive to home NIV treatment (Appendix 2)
- On long-term systemic steroid (prednisolone ≥ 7.5 mg per day for ≥ 3 months)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00429156
Start Date
January 1 2007
End Date
February 1 2009
Last Update
October 23 2009
Active Locations (1)
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1
United Christian Hospital
Kwun Tong, Kowloon, Hong Kong, Kln