Weaning Failure Clinical Trial
— WEANOfficial title:
Non Pharmacological Randomized Clinical Trial Designed to Evaluate the Difference of the Duration of Weaning Process From the Ventilator Between Protocol-driven Weaned Patients and Clinical-driven Weaned Patients.
Verified date | April 2015 |
Source | Università degli Studi di Brescia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
The purpose of this study is to evaluate the difference of the duration of weaning process from the ventilator between protocol-driven weaned patients and clinical judgment driven weaned patients.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. all patients that are clinically identified as prolonged to wean (failed 3 spontaneous breathing trials or 7 days or more of mechanical ventilation after the initial unsuccessful trial) and tracheostomized in ICU 2. improvement or resolution of the underlying causes of acute respiratory failure ratio between pressure partial artery of oxygen and fraction inspired oxygen (PaO2/FiO2) >200 with fraction inspired oxygen (FiO2)< 0,45. 3. pressure supported ventilation at the time of enrollment. Exclusion Criteria: 1. patients assessed as easy weaning and not tracheostomized; 2. patients already tracheostomized on admission to ICU. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Institute of Anesthesiology and Intensive Care of the University of Brescia, Spedali Civili, Italy, | Brescia |
Lead Sponsor | Collaborator |
---|---|
ELENA PELI,MD |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ICU length of stay | within the first 26 days (plus or minus 22 days) after ICU recovery | No | |
Other | success of weaning | spontaneous breathing for 48 hours | No | |
Primary | duration of weaning | within the first 15 days (plus or minus 5 days) after start of weaning | No | |
Secondary | duration of mechanical ventilation | within the first 12 days (plus or minus 10 days) after start of mechanical ventilation | No |
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