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

NCT00678912 | Completed DMC

• 1 other identifier: CHUSJ-2239
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

mechanical ventilation; automated weaning; children

Outcome Measures

Primary Outcomes (1)

• Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation.

  first extubation or 28 days

Secondary Outcomes (4)

• Total mechanical ventilation duration

  first extubation or 28 days

• Proportion of time in the acceptable breathing zone

  first extubation or 28 days

• Weaning failure

  48 hours after first extubation

• Number of interventions on the ventilator by a physician or physiotherapist

  First extubation or 28 days

Study Arms (2)

1

EXPERIMENTAL

Children are mechanically ventilated with Smartcare/PS

Device: Smartcare/PS

2

NO INTERVENTION

Children are mechanically ventilated with usual care

Interventions

Smartcare/PS DEVICE

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

Also known as: Weaning from mechanical ventilation with Smartcare/PS

1

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

CHU Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (2)

• 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.

  PMID: 17693913 BACKGROUND

• 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.

  PMID: 23361631 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Philippe A Jouvet, MD PhD

  Université de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: September 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

CA (1)