Background: Every year in Canada, 6 000 children that are not capable to assume their respiratory work require mechanical ventilation to support their breathing efforts. Non-invasive (NIV) has been developed to support the ventilation without having to place a tube in the trachea (support delivered via a mask). NIV aims to limit the complications related to invasive ventilation. NIV is increasingly used in pediatric intensive care unit (PICU), while its interest has not been well studied. The clinical benefit is sometimes evident, explaining this wide use. However, NIV is not always successful and patients who fail an NIV trial have a worse evolution. An important cause of failure is the inability of the ventilator to detect the patient efforts, resulting in conflict between the patient and the ventilator actions. NAVA (neurally adjusted ventilatory assist) is a new ventilatory mode, which faster detects the patient efforts, based on the detection of the activation of the main inspiratory muscle.
The overall objective of this program is to enhance NIV effectiveness in children using two axes: 1- by increasing the quality of the NIV support using NAVA, and 2- by limiting NIV associated risks with a better selection of the patients that are placed on NIV.
Design: This program includes the following steps:
Axe 1:
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Monocenter feasibility study to assess the feasibility of noninvasive NAVA (CHU Sainte-Justine – Ongoing, end in December 2012): pilot study enrolling 15 critically ill children requiring NIV. Breathing efforts, ventilator synchrony, and tolerance will be recorded successively during conventional NIV (as prescribed by attending physician), 1 hour with NAVA, and a second period with conventional NIV.
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Single center randomized trial to assess the impact of non-invasive NAVA on respiratory distress (CHU Sainte-Justine, planned for 2013). Children requiring NIV will be randomly ventilated either with NAVA or with conventional NIV. Primary outcome measure will be the evolution of the respiratory rate and PaCO2 after two hours of NIV, two variables which are important surrogates of NIV success.
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Perspective : multicenter randomized trial of non-invasive NAVA. Primary outcome measure will be the ventilatory duration or the NIV failure.
Axe 2:
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Multicenter observational study of NIV practices across Canadian Pediatric intensive care unit: (planned for 2013-14). During 12 months, NIV use will be systematically recorded in the participating centers. Patient characteristics, ventilation parameters, and outcome (rate of intubation, length of support, length of stay, mortality) will be collected. The main objective is to identify factors associated with a bad evolution with NIV.
STATUS OF THE PROGRAM:
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Enrolling (NAVA Pilot)
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Not Yet Enrolling (observational study of NIV practices and NAVA randomized trials)
* Pilot NAVA study : CHU Sainte Justine
* For the observational study of NIV practices (list in progress, will be precised in the following weeks) :
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CHU Sainte Justine, Montreal, Quebec
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Children's Hospital of Western Ontario, London, Ontario
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McMaster Children’s Hospital, Hamilton, Ontario
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Sherbrooke University Hospital, Sherbrooke, Quebec
Centre Mère-Enfant du CHUQ, Quebec city, Quebec
Alberta Children’s Hospital, Calgary, Alberta
BC Children's Hospital, Vancouver, British Columbia