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Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease

Primary Purpose

Tetralogy of Fallot, Hypoplastic Left Heart Syndrome, Univentricular Heart

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Neurally adjusted ventilatory assist first
Conventional ventilation first
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tetralogy of Fallot

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Justine's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Neurally adjusted ventilatory assist first

Conventional ventilation first

Arm Description

Ventilation in NAVA mode then ventilation in conventional mode

Ventilation in conventional mode then ventilation in NAVA mode

Outcomes

Primary Outcome Measures

Brain perfusion
cerebral blood flow measured with diffuse correlation spectroscopy (mm2/s)
Brain oxygenation
cerebral tissue saturation measured with near-infrared spectroscopy (%)
Brain oxygen extraction
Cerebral tissue oxygen extraction measured with near-infrared spectroscopy (%)

Secondary Outcome Measures

Brain regional oxygen consumption
Cerebral tissue oxygen extraction measured with near-infrared spectroscopy
Cardiac output
Cardiac output measured using sub aortic time-velocity integral measured on cardiac ultrasound
Cardiac index
Cardiac index measured using sub aortic time-velocity integral measured on cardiac ultrasound
Oxygen transport
According to the following calculation: 1.34 x hemoglobin x SaO2 + 0.0031 x PaO2
Mean airway pressure (cmH2O)
Mean airway pressure (cmH2O) extracted from the ventilator every 30 seconds
Tidal volume
extracted from the ventilator every 30 seconds
Respiratory rate
extracted from the ventilator every 30 seconds
Minute ventilation
extracted from the ventilator every 30 seconds
Electrical activity of the diaphragm
extracted from the ventilator every 30 seconds
PaO2/FiO2 ratio
Ratio calculated at the end of each ventilation period, based on arterial blood gas

Full Information

First Posted
September 27, 2020
Last Updated
December 21, 2022
Sponsor
St. Justine's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04581668
Brief Title
Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease
Official Title
Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Scientific context In post-operative cardiac surgery, invasive ventilation is often necessary, but the induced positive intra thoracic pressures can be detrimental to hemodynamics via several mechanisms: decrease in venous return, increase in pulmonary vascular resistance and increase in the afterload of the right ventricle. This effect is particularly problematic in patients with a restrictive right ventricle, who are preload dependent, and in patients with cavo pulmonary connections for single ventricle palliation. In these patients, decreasing ventilator positive pressure improves cardiac output and cerebral oxygenation. However, very early extubation is not always possible or safe, and it is therefore essential to optimize mechanical ventilation in order to minimize its hemodynamic consequences. In adults, ventilation in NAVA (Neurally Adjusted Ventilatory Assist) mode, regardless of the level of assistance, allows the preservation of intra thoracic pressure variations characteristic of spontaneous ventilation and limits the impact of ventilation on right ventricular ejection. In children, inspiratory and mean pressures are also lower in NAVA compared to conventional ventilation. Assessment of brain oxygenation and perfusion in cardiovascular resuscitation is important both as a hemodynamic parameter and as a neurological prognostic factor. An innovative non-invasive tool, Diffuse Correlation Spectroscopy coupled with Near Infrared Spectroscopy (DCS-NIRS), allows the non-invasive evaluation of both cerebral oxygenation and variations in cerebral blood flow. Hypothesis and objectives The hypothesis is that the NAVA ventilation mode, which generates lower intra thoracic pressures than conventional ventilation modes, will improve cerebral hemodynamics, cardiac output, and oxygen transport of at-risk patients in the post-operative cardiac surgery setting compared with conventional ventilation. Main objective: In pediatric patients following cardiac surgery with risk of right ventricular diastolic dysfunction or passive pulmonary venous return (including Glenn, hemi-Fontan, Fontan, and Tetralogy of Fallot surgery), investigators will evaluate the impact of NAVA ventilation on: cerebral perfusion: cerebral blood flow (mm2/s) measured by DCS. cerebral oxygenation: cerebral tissue saturation (%) and regional cerebral O2 extraction (OEF, measured by NIRS-DCS). Secondary objective: In pediatric post-operative cardiac surgery patients with risk of restrictive right ventricle or passive pulmonary venous return (including Glenn, hemi-Fontan, Fontan, and Tetralogy of Fallot type surgery), investigators will compare the impact of conventional ventilation to NAVA mode on: Brain regional O2 consumption extracted from NIRS-DCS measurements Systemic hemodynamics, including cardiac index, lactate level, central venous oxygen saturation (ScvO2), and oxygen transport Ventilation parameters Comfort as measured by the COMFORT scale Methods This is a prospective cross-over, single-center, physiological study to be conducted in the Pediatric Intensive Care Unit of CHU Sainte Justine (Montreal, Canada). Two periods of 60 minutes in each of 2 ventilation modes will be compared: conventional ventilation mode (as prescribed by the treating team) and NAVA mode, in random order. On admission to the PICU postoperatively, study patients will be fitted with a naso-gastric NAVA probe. Before performing any study measurements, investigators will wait for patient stabilization, which is defined by: absence of hemodynamically significant bleeding stabilization of the ventilation parameters stable inotrope dose The order of the 2 ventilation periods will be randomized according to a previously generated random list. Study period ventilation will be set as follows: conventional ventilation: ventilation as prescribed by the treating team will be continued. Usually, ventilation is in PRVC (pressure regulated volume control) mode with a tidal volume between 5 and 8 mL/kg, a peep between 4 and 5, a respiratory rate to aim for normocapnia, and FiO2 to aim for PaO2 between 100 and 150 mmHg. NAVA Mode: NAVA level setting to target an Edi level between 3 and 20 V, tidal volume between 5 and 7 mL/kg, and no respiratory distress on physical examination. The trigger will be set at 0.5 V. The maximum pressure will be limited to 30 cmH2O. The PEEP level will not be changed from that prescribed by the treating physician. To facilitate comparability of brain flow and oxygenation measurements, FiO2, NO concentration, inotrope dose, and sedation will be kept as stable as possible during these periods, at the discretion of the treating physician. Similarly, if possible, blood transfusions will not be administered during the study period. During the two periods of ventilation, the following parameters will be recorded continuously: ventilatory parameters: ventilator parameters according to the set mode: peak inspiratory pressure, mean airway pressure, PEEP, tidal volume, total and spontaneous minute ventilation, Edi level, FiO2, exhaled CO2 via volumetric capnography. hemodynamic parameters: heart rate (HR), mean arterial pressure, systolic, diastolic, central venous pressure (CVP), left atrial pressure (LAP), type and dose of vasoactive medications received with calculation of the vasoactive-inotropic score. In the second half of each period, investigators will perform: a central arterial and venous blood gas and an arterial lactate measurement. a measurement of cerebral blood flow by diffuse correlation spectroscopy and a measurement of cerebral regional tissue saturation and oxygen extraction. These measurements are done non-invasively and painlessly by applying a probe to the child's forehead for approximately 20 minutes. a limited cardiac ultrasound for the calculation of cardiac output (CO). calculation of urine output during the ventilation period. In addition, for each patient, the following information will be collected: age at the time of surgery cardiac diagnosis existence and quantification of aorto-pulmonary collaterals preoperative medications operative details: surgical procedure, duration of cardiopulmonary bypass, aortic cross-clamp duration, inotropes administered (and maximum dose). result of the postoperative trans-esophageal cardiac echo (cardiac function, evaluation of repair, presence of residual anatomic lesions) arterial and venous blood gases, lactate and haemoglobin levels prior to study ventilation periods time interval between the end of cardiopulmonary bypass and the start of study measurements The variables will be expressed in terms of mean standard deviation or median (interquartile), depending on the nature of their distribution. Because of the sample size, analysis of the differences between t variables during the 2 modes of ventilation will be done using the non-parametric Wilcoxon test (all the variables studied are of the continuous type). A value of p <0.05 will be considered significant. For the calculation of sample size, investigators estimated, using the study by Huang et al (4), that the standard deviation of brain saturation would be 6%, and that the expected difference between the 2 ventilation modes would be at least 6%. To reach a power of 90% with an alpha risk set at 0.05, a minimum of 24 patients is required. Given the risk of loss of sight (e.g. technical difficulty in obtaining the main variable) and due to the heterogeneity of the patient population, we decided to aim to include 30 patients. Note that no power calculation based on the variations in cerebral blood flow measured in spectroscopy was performed, because there was no preliminary data on the subject. Approval from the Research Ethics Committee of Sainte Justine University Hospital and the University Medical Affairs Department was obtained. Written consent will be required from the parents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetralogy of Fallot, Hypoplastic Left Heart Syndrome, Univentricular Heart, Heart Defects, Congenital

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cross over physiological study with 2 different phases with a 30 minute Wash out period: 30 minutes. Order will be randomized.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurally adjusted ventilatory assist first
Arm Type
Other
Arm Description
Ventilation in NAVA mode then ventilation in conventional mode
Arm Title
Conventional ventilation first
Arm Type
Other
Arm Description
Ventilation in conventional mode then ventilation in NAVA mode
Intervention Type
Other
Intervention Name(s)
Neurally adjusted ventilatory assist first
Intervention Description
Invasive ventilation in Neurally adjusted ventilatory assist during 60 minutes followed by a 30 minutes wash out period then ventilation in conventional mode
Intervention Type
Other
Intervention Name(s)
Conventional ventilation first
Intervention Description
Invasive ventilation in conventional mode during 60 minutes followed by a 30 minutes wash out period then ventilation in Neurally adjusted ventilatory assist
Primary Outcome Measure Information:
Title
Brain perfusion
Description
cerebral blood flow measured with diffuse correlation spectroscopy (mm2/s)
Time Frame
30 minutes
Title
Brain oxygenation
Description
cerebral tissue saturation measured with near-infrared spectroscopy (%)
Time Frame
30 minutes
Title
Brain oxygen extraction
Description
Cerebral tissue oxygen extraction measured with near-infrared spectroscopy (%)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Brain regional oxygen consumption
Description
Cerebral tissue oxygen extraction measured with near-infrared spectroscopy
Time Frame
30 minutes
Title
Cardiac output
Description
Cardiac output measured using sub aortic time-velocity integral measured on cardiac ultrasound
Time Frame
30 minutes
Title
Cardiac index
Description
Cardiac index measured using sub aortic time-velocity integral measured on cardiac ultrasound
Time Frame
30 minutes
Title
Oxygen transport
Description
According to the following calculation: 1.34 x hemoglobin x SaO2 + 0.0031 x PaO2
Time Frame
50 minutes
Title
Mean airway pressure (cmH2O)
Description
Mean airway pressure (cmH2O) extracted from the ventilator every 30 seconds
Time Frame
60 minutes
Title
Tidal volume
Description
extracted from the ventilator every 30 seconds
Time Frame
60 minutes
Title
Respiratory rate
Description
extracted from the ventilator every 30 seconds
Time Frame
60 minutes
Title
Minute ventilation
Description
extracted from the ventilator every 30 seconds
Time Frame
60 minutes
Title
Electrical activity of the diaphragm
Description
extracted from the ventilator every 30 seconds
Time Frame
60 minutes
Title
PaO2/FiO2 ratio
Description
Ratio calculated at the end of each ventilation period, based on arterial blood gas
Time Frame
50 minutes
Other Pre-specified Outcome Measures:
Title
Patient comfort
Description
Measured by the COMFORT-B scale (ranges: 6-30, the lowest being the better)
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Emeriaud, Dr
Phone
514 345 4931
Ext
3316
Email
guillaume.emeriaud@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Geneviève Dupont-Thibodeau, Dre
Phone
514 345 4931
Ext
3316
Email
genevievedpt@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Emeriaud, Dr
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Justine's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Emeriaud, MD, PhD
Phone
514-345-4931
Ext
3316
Email
guillaume.emeriaud@gmail.com
First Name & Middle Initial & Last Name & Degree
Lucy Clayton, MSc
Phone
514-345-4931
Ext
6816
Email
lucy.clayton@recherche-ste-justine.qc.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease

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