Weaning Children From Mechanical Ventilation:Computer-Driven System Versus Usual Care - Full Text View

Sponsors and Collaborators:	University of Montreal Fonds de la Recherche en Santé du Québec
Information provided by:	University of Montreal
ClinicalTrials.gov Identifier:	NCT00678912

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Single Center Randomized Clinical Trial Comparing Weaning From Mechanical Ventilation With Computer-Driven System vs Usual Care in Children

Further study details as provided by University of Montreal:

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 ]

Estimated Enrollment:	30
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: No Intervention 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

Contacts

Contact: Philippe A Jouvet, MD PhD

514-345-4931 ext 4927

philippe.jouvet@umontreal.ca

Locations

Canada, Quebec
CHU Sainte Justine	Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Philippe A Jouvet, MD PhD 514-345-4931 ext 4927 philippe.jouvet@umontreal.ca
Principal Investigator: Philippe A Jouvet, MD phD
Sub-Investigator: Valérie Payen, MD

Sponsors and Collaborators

University of Montreal

Fonds de la Recherche en Santé du Québec

Investigators

Principal Investigator:

Philippe A Jouvet, MD PhD

Université de Montreal

More Information

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.

Responsible Party:	University of Montreal ( Philippe Jouvet MD )
Study ID Numbers:	CHUSJ-2239
Study First Received:	May 14, 2008
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00678912
Health Authority:	Canada: Health Canada

Keywords provided by University of Montreal:

mechanical ventilation
automated weaning
children

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on January 15, 2009