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| Name | Class |
|---|---|
| Fonds de la Recherche en Santé du Québec | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Children are mechanically ventilated with Smartcare/PS |
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| 2 | No Intervention | Children are mechanically ventilated with usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartcare/PS | Device | computer-driven protocol that adjusts pressure support level in pressure support mode to patient respiratory status |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe A Jouvet, MD PhD | Université de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17693913 | Background | Jouvet P, Farges C, Hatzakis G, Monir A, Lesage F, Dupic L, Brochard L, Hubert P. Weaning children from mechanical ventilation with a computer-driven system (closed-loop protocol): a pilot study. Pediatr Crit Care Med. 2007 Sep;8(5):425-32. doi: 10.1097/01.PCC.0000282157.77811.F9. | |
| 23361631 | Derived | Jouvet PA, Payen V, Gauvin F, Emeriaud G, Lacroix J. Weaning children from mechanical ventilation with a computer-driven protocol: a pilot trial. Intensive Care Med. 2013 May;39(5):919-25. doi: 10.1007/s00134-013-2837-8. Epub 2013 Jan 30. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 48 hours after first extubation |
| Number of interventions on the ventilator by a physician or physiotherapist | First extubation or 28 days |