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

NCT ID: NCT00678912

Last Updated: 2012-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-07-31

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.

Conditions

Respiratory Failure

Keywords

mechanical ventilation; automated weaning; children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Children are mechanically ventilated with Smartcare/PS

Group Type: EXPERIMENTAL

Smartcare/PS

Intervention Type: DEVICE

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

2

Children are mechanically ventilated with usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Smartcare/PS

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

Intervention Type: DEVICE

Other Intervention Names

Weaning from mechanical ventilation with Smartcare/PS

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Philippe Jouvet

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippe A Jouvet, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Montreal

Locations

CHU Sainte Justine

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 17693913 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23361631 (View on PubMed)

Other Identifiers

CHUSJ-2239

Identifier Type: -

Identifier Source: org_study_id