CHU Sainte Justine
Montreal, Quebec, H3T 1C5, Canada
NCT Number: NCT00678912
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.
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Notify Me2 year–18 year
All sexes
Interventional
Not applicable
Montreal, Quebec, H3T 1C5, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
computer-driven protocol that adjusts pressure support level in pressure support mode to patient respiratory status
Other names: Weaning from mechanical ventilation with Smartcare/PS
Time frame: first extubation or 28 days
Time frame: first extubation or 28 days
Time frame: first extubation or 28 days
Time frame: 48 hours after first extubation
Time frame: First extubation or 28 days
St. Justine's Hospital
Other
Single Center Randomized Clinical Trial Comparing Weaning From Mechanical Ventilation With Computer-driven System vs Usual Care in Children
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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