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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00678912
Recruitment Status : Completed
First Posted : May 16, 2008
Last Update Posted : September 19, 2012
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Philippe Jouvet, St. Justine's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: Smartcare/PS Phase 3

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Center Randomized Clinical Trial Comparing Weaning From Mechanical Ventilation With Computer-driven System vs Usual Care in Children
Study Start Date : September 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: 1
Children are mechanically ventilated with Smartcare/PS
Device: Smartcare/PS
computer-driven protocol that adjusts pressure support level in pressure support mode to patient respiratory status
Other Name: Weaning from mechanical ventilation with Smartcare/PS

No Intervention: 2
Children are mechanically ventilated with usual care

Primary Outcome Measures :
  1. Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation. [ Time Frame: first extubation or 28 days ]

Secondary Outcome Measures :
  1. Total mechanical ventilation duration [ Time Frame: first extubation or 28 days ]
  2. Proportion of time in the acceptable breathing zone [ Time Frame: first extubation or 28 days ]
  3. Weaning failure [ Time Frame: 48 hours after first extubation ]
  4. Number of interventions on the ventilator by a physician or physiotherapist [ Time Frame: First extubation or 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00678912

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Canada, Quebec
CHU Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Fonds de la Recherche en Santé du Québec
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Principal Investigator: Philippe A Jouvet, MD PhD Université de Montreal
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Philippe Jouvet, Associate Professor, St. Justine's Hospital Identifier: NCT00678912    
Other Study ID Numbers: CHUSJ-2239
First Posted: May 16, 2008    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012
Keywords provided by Philippe Jouvet, St. Justine's Hospital:
mechanical ventilation
automated weaning
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases