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Completed

NCT Number: NCT00678912

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

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartcare/PS

Device

computer-driven protocol that adjusts pressure support level in pressure support mode to patient respiratory status

Other names: Weaning from mechanical ventilation with Smartcare/PS

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

  • Fonds de la Recherche en Santé du Québec

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 16, 2008
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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