Respiratory Failure Clinical Trial
Official title:
Single Center Randomized Clinical Trial Comparing Weaning From Mechanical Ventilation With Computer-driven System vs Usual Care in Children
The purpose of this study is to determine whether a computer-driven system (Smartcare/PS) decreases weaning duration from mechanical ventilation when compared to usual care in children.
Baseline data: All subjects included into this RCT will undergo routine examination upon
admission to the hospital. These examinations include physical, medical/medication history
(on the last year for medical history and the last 3 months for medication history (if
available), vital signs, radiologic data and laboratory tests.
Intervention: A pre-inclusion test (pressure support test) with a level of pressure support
of ± 5 cmH2O of the P plateau, but no greater than 30 cmH2O (pressure-support level plus
positive end-expiratory pressure), is performed to evaluate the patient's tolerance of this
ventilation mode; the test is repeated daily until positive. The test could be stopped
before 30 minutes if the patient showed evidence of respiratory distress (respiratory rate >
40 breaths per minute and FiO2 > 60% in order to obtain pulse oxymetry ≥ 95%). The test is
considered positive when, after 30 minutes, the patient remained clinically stable with a
respiratory rate lower than 40 breaths per minute and an expiratory tidal volume higher than
6 ml per kilogram of body weight within the authorized pressure-support range, with pulse
oxymetry no lower than 95 percent when the fraction of inspired oxygen was no greater than
60 percent. When the pressure-support test is positive, the patient is randomized either to
Arm 1 where the intervention is weaning with the support of Smartcare/PS or to Arm 2 where
the intervention is weaning based on usual care. Both group are ventilated with the same
ventilator: Evita XL.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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