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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 18, 2014