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

NCT04581668 | Completed

• 1 other identifier: 2021-2731
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 conventional mode and NAVA mode. 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.

Conditions

Tetralogy of Fallot; Univentricular Heart; Hypoplastic Left Heart Syndrome; Heart Defects, Congenital

Keywords

PICU, congenital heart disease, NAVA, cardiopulmonary interaction

Outcome Measures

Primary Outcomes (3)

• Brain perfusion

  cerebral blood flow measured with diffuse correlation spectroscopy (mm2/s)

  5 minute period at the end of each 60-minute ventilatory periods

• Brain oxygenation

  cerebral tissue saturation measured with near-infrared spectroscopy (%)

  median value of the continuous measurement during each of the two 60-minute ventilatory periods

• Brain oxygen extraction

  Cerebral tissue oxygen extraction measured with near-infrared spectroscopy (%)

  5 minute period at the end of each 60-minute ventilatory periods

Secondary Outcomes (10)

• Brain regional oxygen consumption

  5 minute period at the end of each 60-minute ventilatory periods

• Cardiac output

  in the 10 minute period at the end of each 60-minute ventilatory periods

• Cardiac index

  in the 10 minute period at the end of each 60-minute ventilatory periods

• Oxygen transport

  in the 10 minute period at the end of each 60-minute ventilatory periods

• Mean airway pressure (cmH2O)

  median value of the continuous measurement during each of the two 60-minute ventilatory periods

Other Outcomes (1)

• Patient comfort

  MEdian value within each of the two 60-minute ventilatory periods

Interventions

Two ventilation periods with two different modes: conventional ventilation followed by NAVA. OTHER

The patients will be ventilated successively using conventional ventilation followed by NAVA for 30-60 minutes each. Echocardiography and blood gases will be performed at the end of each period. Vital signs and ventilatory parameters will be continuously collected.

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

St. Justine's Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Tetralogy of Fallot; Hypoplastic Left Heart Syndrome; Univentricular Heart; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Guillaume Emeriaud, Dr

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: A cross-over physiological study consisting of two distinct phases, each lasting 30 to 60 minutes.

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 9, 2020
• Study Start: October 5, 2020
• Primary Completion: February 3, 2026
• Study Completion: February 3, 2026
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

CA (1)