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

This study has been completed.
Sponsor:
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Philippe Jouvet, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT00678912
First received: May 14, 2008
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Respiratory Failure
 Device: Smartcare/PS
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total mechanical ventilation duration [ Time Frame: first extubation or 28 days ] [ Designated as safety issue: No ]
  • Proportion of time in the acceptable breathing zone [ Time Frame: first extubation or 28 days ] [ Designated as safety issue: No ]
  • Weaning failure [ Time Frame: 48 hours after first extubation ] [ Designated as safety issue: No ]
  • Number of interventions on the ventilator by a physician or physiotherapist [ Time Frame: First extubation or 28 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2007
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678912

Locations
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
Investigators
Principal Investigator: Philippe A Jouvet, MD PhD Université de Montreal
  More Information

Publications:

Responsible Party: Philippe Jouvet, Associate Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT00678912     History of Changes
Other Study ID Numbers: CHUSJ-2239
Study First Received: May 14, 2008
Last Updated: September 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
mechanical ventilation
automated weaning
children

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013