Respiratory Failure Clinical Trial
— VHYPEROfficial title:
Sequential and Early Used of Noninvasive Ventilation After Extubation in Hypercapnic Patients or in Patients With Chronic Respiratory Disorders
The purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.
Status | Completed |
Enrollment | 144 |
Est. completion date | August 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients intubated for 48 hours or more - Patients with Chronic respiratory disorders - And/or hypercapnic respiratory failure during successful spontaneous breathing trial Exclusion Criteria: - Face or cranial trauma or surgery - Home noninvasive ventilation - Recent gastric or oesophageal surgery - Tracheostomy or other upper airway disorders - Upper gastrointestinal bleeding - Excess respiratory secretions - Lack of collaboration - Do not resuscitate order or any decision to limit therapeutic effort in the ICU. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hospital | Agen | |
France | Pellegrin Hospital, Recovery Unit | Bordeaux | |
France | Saint-André Hospital | Bordeaux | |
France | Hospital | Libourne | |
France | University Hospital | Limoges | |
France | University Hospital | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of respiratory failure after extubation | 2 days | No | |
Secondary | Incidence of reintubation | 2 months | No | |
Secondary | Length of stay in Intensive Care Unit | 2 months | No | |
Secondary | Hospital mortality | 2 months | No | |
Secondary | Survival | 28th day | No | |
Secondary | Survival | 90th day | No | |
Secondary | Incidence of complications associated to mechanical ventilation | 2 months | No |
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