Status:
UNKNOWN
Comparison of Pressure Support and Pressure Control Ventilation in Chronic Respiratory Failure
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
COPD
Chest Wall Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is looking at whether there is a difference in outcomes using two different types of breathing support in those patients who have chronic respiratory failure (patients who under-breathe). ...
Eligibility Criteria
Inclusion
- Patients with chest wall deformity, neuromuscular disease or obesity hypoventilation syndrome with an FEV1/FVC ratio of \>70% and VC \<50% predicted or patients with COPD with a FEV1/FVC ratio of \<70% an FEV1 \<50% predicted
- Stable
- pH \>7.35
- ESS \<18
- Symptomatically stable with clinical resolution of intercurrent infection: normal C reactive protein, white cell count and afebrile
- Daytime symptoms compatible with nocturnal hypoventilation i.e. poor sleep, morning headache, daytime somnolence, shortness of breath
- Arterial carbon dioxide partial pressure (PaCO2) \> 6.0kPa during day with evidence of nocturnal hypoventilation (TcCO2 \>7.5KPa or a rise in TcCO2 of \>1 KPa)
- No prior domiciliary ventilation use
- Patients with COPD must be established on optimal medical treatment prior to enrolment
Exclusion
- Psychological, social or geographical situation that would impair compliance with the schedule
- Patients who have underlying malignancy or severe cardiac dysfunction (ejection fraction \<40%)
- Complex OSA
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00994552
Start Date
August 1 2009
Last Update
October 14 2009
Active Locations (1)
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1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH