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

NCT04581668 | Unknown

• 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 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Brain perfusion

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

  30 minutes

• Brain oxygenation

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

  30 minutes

• Brain oxygen extraction

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

  30 minutes

Secondary Outcomes (10)

• Brain regional oxygen consumption

  30 minutes

• Cardiac output

  30 minutes

• Cardiac index

  30 minutes

• Oxygen transport

  50 minutes

• Mean airway pressure (cmH2O)

  60 minutes

Other Outcomes (1)

• Patient comfort

  60 minutes

Study Arms (2)

Neurally adjusted ventilatory assist first

OTHER

Ventilation in NAVA mode then ventilation in conventional mode

Other: Neurally adjusted ventilatory assist first

Conventional ventilation first

OTHER

Ventilation in conventional mode then ventilation in NAVA mode

Other: Conventional ventilation first

Interventions

Neurally adjusted ventilatory assist first OTHER

Invasive ventilation in Neurally adjusted ventilatory assist during 60 minutes followed by a 30 minutes wash out period then ventilation in conventional mode

Neurally adjusted ventilatory assist first

Conventional ventilation first OTHER

Invasive ventilation in conventional mode during 60 minutes followed by a 30 minutes wash out period then ventilation in Neurally adjusted ventilatory assist

Conventional ventilation first

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

RECRUITING

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

Central Study Contacts

Guillaume Emeriaud, Dr

CONTACT

514 345 4931; guillaume.emeriaud@umontreal.ca

Geneviève Dupont-Thibodeau, Dre

CONTACT

514 345 4931; genevievedpt@gmail.com

Study Design

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

Model Details: Cross over physiological study with 2 different phases with a 30 minute Wash out period: 30 minutes. Order will be randomized.

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 9, 2020
• Study Start: October 5, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

CA (1)