Status:
UNKNOWN
Prevention of Reintubation by Using Noninvasive Positive Pressure Ventilation
Lead Sponsor:
UPECLIN HC FM Botucatu Unesp
Conditions:
Extubation Failure
Acute Respiratory Failure Post Extubation
Eligibility:
All Genders
28-15 years
Phase:
PHASE3
Brief Summary
Child extubation failure range from 4.1% to 19%. Studies in adults and children showed that extubation failure increases mortality mainly in those who need reintubation as this is a invasive procedure...
Detailed Description
Prospective, randomized and controlled study at the PICU - University Hospital, Botucatu Medical School-UNESP. Patients elegibled are exposed to extubation test. If passed they are randomized in two g...
Eligibility Criteria
Inclusion
- Patients aged between 28 days and 15 years and who were intubated and remained under invasive mechanical ventilation for 48 hours, passed in the extubation test for, and who presented at least one of the following risk factors for respiratory distress post extubation:
- Invasive ventilation for at least 15 days
- Use of inotropics for more than 48 hours
- Endovenous continuous administration of sedative/analgesic drugs
- 1-3 months old
- Mean Airway Pressure(Paw)\> 8,5; Inspired fraction of O2(FiO2)\> 0,4; Oxygenation index(IO)\> 4,5 immediately before extubation
- Cardiac or pulmonary chronic diseases
- Cardiac output
- Hipercapny: Arterial pressure of CO2 (PaCO2)\> 45 mmHg
Exclusion
- Tracheostomized
- Accidental extubation
- Respiratory failure just after extubation, needing immediate reintubation
- Neuromuscular diseases
- Death
- PPNIV exclusion: coma or disability to protect airway, not tolerated, hemodynamic instability, shock, cardiac disritmy, facial or intracranial traumatic injury or surgery that preclude use of mask, abdominal distension, nausea or vomiting, gastric or esophagic recent surgery, gastrointestinal hemorrhagy in activity, not drained pneumothorax.
- Reintubated patients during its stay in PICU, that have already participated in this study
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00977002
Start Date
March 1 2008
End Date
December 1 2010
Last Update
February 2 2011
Active Locations (1)
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1
Botucatu Medical School-UNESP
Botucatu, São Paulo, Brazil, 18.618-970