Clinical Trial Assessing Two Protocols to Withdraw Non-invasive Ventilation in Hypercapnic Respiratory Failure
Phase 4
Completed
- Conditions
- Hypercapnic Respiratory Failure
- Interventions
- Device: Nocturnal non-invasive ventilation
- Registration Number
- NCT00775710
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
The purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
- Acute hypercapnic respiratory failure.
- Use of NIV to treat respiratory failure.
- Persistence of hypercapnia after discontinuation of NIV
Exclusion Criteria
- Home NIV
- Facial or cranial trauma or surgery,
- Recent gastric or esophageal surgery,
- Active upper gastrointestinal bleeding,
- Excessive amount of respiratory secretions,
- Tracheostomy
- Lack of cooperation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Nocturnal non-invasive ventilation Non-invasive ventilation is maintained during three nights after recovery of an episode of hypercapnic respiratory failure.
- Primary Outcome Measures
Name Time Method New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation At the end of enrollment time
- Secondary Outcome Measures
Name Time Method Incidence of long term dependency on non-invasive ventilation At the end of enrollment time Hospital and 6-month survival At the end of enrollment time
Trial Locations
- Locations (3)
Hospital de Sant Pau
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Clinic
🇪🇸Barcelona, Spain