Recruiting

NAVA Ventilation

Sponsor:

St. Justine's Hospital

Code:

NCT04581668

Conditions

Tetralogy of Fallot

Hypoplastic Left Heart Syndrome

Univentricular Heart

Heart Defects, Congenital

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Neurally adjusted ventilatory assist first

Conventional ventilation first

Study Details

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

Study ID

NCT04581668

Start date

Oct 5, 2020

Status verified date

Dec, 2022

Completion date

Dec 1, 2023

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Neurally adjusted ventilatory assist first

Ventilation in NAVA mode then ventilation in conventional mode

other: Conventional ventilation first

Ventilation in conventional mode then ventilation in NAVA mode

Interventions

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

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

Primary outcome measure

  • Brain perfusion [ Time Frame: 30 minutes ]
  • Brain oxygenation [ Time Frame: 30 minutes ]
  • Brain oxygen extraction [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Geneviève Dupont-Thibodeau, Dre

514 345 4931genevievedpt@gmail.com

Locations

St. Justine's Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

More Information

Sponsor

St. Justine's Hospital

Last update posted

Dec 22, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2022-12-22.