Status:
COMPLETED
Ambulatory Adaptation to Non-Invasive Mechanical Ventilation
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Hospital Universitari Vall d'Hebron Research Institute
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Chronic Respiratory Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive mechanical ventilation in patient with hypercapnic respiratory failure secondary to neuromuscular diseases or al...
Eligibility Criteria
Inclusion
- Age between 18 and 75
- Chronic respiratory insufficiency secondary to neuromuscular disease or thoracic cage alterations with indication of non-invasive mechanical ventilation (presence of fatigue, dyspnea, morning headache, etc) plus one of the following criteria):
- PaCO2 \> 45 mmHg
- Night time oxygen saturation \< 88% at least for 5 consecutive minutes
- In neuromuscular diseases, PIM \< 60 cmH2O or FVC \< 50% of theoretical.
- Stable disease.
- Airway access through nasal mask.
- Ability to provide written informed consent.
- Ability to attend the visits
Exclusion
- Contraindications for mechanical ventilation:
- Patient with terminal disease or vegetative state
- Lack of motivation of the patient
- Lack of family or social support
- Patients clinically unstable
- Agitation or lack of co-operation
- Depression.
- Patients with acute symptoms requiring hospital admission.
- Need for airway access through tracheostomy, face mask or mouth piece.
- Relevant comorbidity (ie. heart failure, diabetes non controlled, infections, malignancies, etc.) leading to difficulties in adaptation to ventilation.
- Use (for 7 days or more) of CNS depressors(benzodiazepines, antihistamines H1, tricyclic antidepressants , antiepileptic or antipsychotic drugs ) in the 30-day period prior to inclusion, or expected need for such drugs during the study.
- Lack of understanding of the study procedures.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00698958
Start Date
June 1 2003
Last Update
June 17 2008
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