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

NCT04581668 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-22

No results posted yet for this study

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

Interventions

OTHER

Neurally adjusted ventilatory assist first

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

OTHER

Conventional ventilation first

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

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Guillaume Emeriaud, Dr · St. Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04581668 on ClinicalTrials.gov