Heart Defects, Congenital Clinical Trial
Official title:
Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease
Positive intra-thoracic pressures induced by mechanical ventilation can negatively impact right heart hemodynamics by restricting systemic venous return and increasing right ventricular afterload. These consequences may be detrimental in patients with a restrictive right ventricular physiology and in patients with single ventricle physiology. NAVA (Neurally Adjusted Ventilatory Assist) ventilation decreases intra thoracic pressures compared to conventional ventilation modes. Brain perfusion is both a hemodynamic indicator and a prognostic factor in cardiac postoperative care. Diffuse Correlation Spectroscopy (DCS) coupled with Near Infrared Spectroscopy (NIRS) is a new technology that allows monitoring, in addition to brain tissue oxygenation, changes in brain blood flow. This physiological study aims to evaluate the impact of NAVA mode ventilation on cerebral and systemic hemodynamics in post-operative cardiac surgery patients with preload dependant right ventricle or with passive venous return to the lungs . This prospective cross-over study will include 30 patients. Once stabilized in intensive care, patients will undergo 2 periods of ventilation in NAVA mode and conventional mode separated by a 30-minute washout period, in a random order. For each period the following information will be collected: changes in cerebral blood flow and cerebral oxygenation, hemodynamic parameters including cardiac output and oxygen transport and ventilatory parameters.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 18 Years |
Eligibility | Inclusion Criteria: 1. admission to the pediatric intensive care unit: - after Glenn, Fontan, Fallot Tetralogy surgery - or after other types of surgery with risk of post-operative occurence of right ventricular failure or low lung output 2. invasive ventilation scheduled for at least 2 hours after admission Exclusion Criteria: - Contraindication to placement of a nasogastric NAVA tube - History of significant focal brain injury (infarction or hemorrhage) - Bilateral phrenic paralysis - Extubation in operating room or planned to be within the hour, - Patient with open chest, uncontrolled shock, need for neuromuscular blockade. Note that for these criteria, the patient may become eligible when these criteria are resolved. - Patients for whom an acute care limitation order is in place. |
Country | Name | City | State |
---|---|---|---|
Canada | St. Justine's Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient comfort | Measured by the COMFORT-B scale (ranges: 6-30, the lowest being the better) | 60 minutes | |
Primary | Brain perfusion | cerebral blood flow measured with diffuse correlation spectroscopy (mm2/s) | 30 minutes | |
Primary | Brain oxygenation | cerebral tissue saturation measured with near-infrared spectroscopy (%) | 30 minutes | |
Primary | Brain oxygen extraction | Cerebral tissue oxygen extraction measured with near-infrared spectroscopy (%) | 30 minutes | |
Secondary | Brain regional oxygen consumption | Cerebral tissue oxygen extraction measured with near-infrared spectroscopy | 30 minutes | |
Secondary | Cardiac output | Cardiac output measured using sub aortic time-velocity integral measured on cardiac ultrasound | 30 minutes | |
Secondary | Cardiac index | Cardiac index measured using sub aortic time-velocity integral measured on cardiac ultrasound | 30 minutes | |
Secondary | Oxygen transport | According to the following calculation: 1.34 x hemoglobin x SaO2 + 0.0031 x PaO2 | 50 minutes | |
Secondary | Mean airway pressure (cmH2O) | Mean airway pressure (cmH2O) extracted from the ventilator every 30 seconds | 60 minutes | |
Secondary | Tidal volume | extracted from the ventilator every 30 seconds | 60 minutes | |
Secondary | Respiratory rate | extracted from the ventilator every 30 seconds | 60 minutes | |
Secondary | Minute ventilation | extracted from the ventilator every 30 seconds | 60 minutes | |
Secondary | Electrical activity of the diaphragm | extracted from the ventilator every 30 seconds | 60 minutes | |
Secondary | PaO2/FiO2 ratio | Ratio calculated at the end of each ventilation period, based on arterial blood gas | 50 minutes |
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