Weaning Children From Mechanical Ventilation:Computer-driven System Versus Usual Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Single Center Randomized Clinical Trial Comparing Weaning From Mechanical Ventilation With Computer-driven System vs Usual Care in Children

Conditions
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Respiratory Failure

Intervention / Treatment
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* Device: Smartcare/PS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The attending physician thinks that the patient will be able to breathe spontaneously or the patients is already breathing spontaneously. No vasopressor or inotropic medication, unless the patient is receiving some digitalin or small doses of dopamine (< 5 µg/kg/min) Slight or no endotracheal tube gas-leakage ([Vti - Vte]/Vti ≤ 20%) Mechanical ventilation with a plateau pressure ≤ 25 cmH2O over PEEP PEEP ≤ 8 cmH2O FiO2 ≤ 60% in order to obtain pulse oxymetry ≥ 95% PaCO2 < 70 mmHg on the last blood gases Extubation not expected the day of inclusion Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Children are mechanically ventilated with Smartcare/PS | Device: Smartcare/PS<br>* computer-driven protocol that adjusts pressure support level in pressure support mode to patient respiratory status<br>* Other names: Weaning from mechanical ventilation with Smartcare/PS;|
| No Intervention: 2<br>Children are mechanically ventilated with usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation. |  | first extubation or 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total mechanical ventilation duration |  | first extubation or 28 days | 
| Proportion of time in the acceptable breathing zone |  | first extubation or 28 days | 
| Weaning failure |  | 48 hours after first extubation | 
| Number of interventions on the ventilator by a physician or physiotherapist |  | First extubation or 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, automated weaning, children