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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: Smartcare/PS

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • CHU Sainte Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Weaning from mechanical ventilation with Smartcare/PS
No Intervention: 2; Children are mechanically ventilated with usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation.	first extubation or 28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Collaborators: Fonds de la Recherche en Santé du Québec
• Investigators: Principal Investigator: Philippe A Jouvet, MD PhD, Université de Montréal

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: May 14, 2008
• First Submitted That Met QC Criteria: May 15, 2008
• First Posted (Estimate): May 16, 2008

Study Record Updates

• Last Update Posted (Estimate): September 19, 2012
• Last Update Submitted That Met QC Criteria: September 18, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: mechanical ventilation; children; automated weaning
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: CHUSJ-2239