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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678912
• Other study ID #: CHUSJ-2239
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2008
• Last updated: September 18, 2012
• Start date: September 2007
• Est. completion date: July 2009

Study information

• Verified date: September 2012
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Smartcare/PS
computer-driven protocol that adjusts pressure support level in pressure support mode to patient respiratory status

Locations

Country	Name	City	State
Canada	CHU Sainte Justine	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
St. Justine's Hospital	Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation.		first extubation or 28 days	No
Secondary	Total mechanical ventilation duration		first extubation or 28 days	No
Secondary	Proportion of time in the acceptable breathing zone		first extubation or 28 days	No
Secondary	Weaning failure		48 hours after first extubation	No
Secondary	Number of interventions on the ventilator by a physician or physiotherapist		First extubation or 28 days	No