Clinical trial NCT00678912: Weaning Children From Mechanical Ventilation:Computer-driven System Versus Usual Care
Official title: Single Center Randomized Clinical Trial Comparing Weaning From Mechanical Ventilation With Computer-driven System vs Usual Care in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Failure
Keywords: mechanical ventilation
automated weaning
children
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2008-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation.
timeFrame: first extubation or 28 days
Secondary outcomes:
measure: Total mechanical ventilation duration
timeFrame: first extubation or 28 days
measure: Proportion of time in the acceptable breathing zone
timeFrame: first extubation or 28 days
measure: Weaning failure
timeFrame: 48 hours after first extubation
measure: Number of interventions on the ventilator by a physician or physiotherapist
timeFrame: First extubation or 28 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte Justine
state: Quebec
Study officials:
affiliation: Université de Montreal
name: Philippe A Jouvet, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.