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Completed

NCT Number: NCT04633343

Effects of Different Tidal Volume Ventilation Strategies on Fontan Flow and Hemodynamics

In patients with Fontan circulation blood is not pumped to the lungs from a ventricle. Instead the superior vena cava and inferior vena cava is connected to the pulmonary artery and blood flow to the lungs occurs passively along this Fontan pathway. This passive blood flow to the lungs occurs best when the patient is breathing on their own (spontaneous ventilation). However for certain surgeries and procedures patients need to have an endotracheal tube inserted and need to be muscle relaxed and receive positive pressure ventilation. Prior studies have shown that positive pressure ventilation can reduce blood flow to the lungs and consequently blood returning to the heart resulting in less blood pumped out to the rest of the body (cardiac output). The purpose of this study is to investigate if changing the volume of the positive pressure ventilation (tidal volume) affects blood flow to the lungs and cardiac output in patients with Fontan circulation.

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Key information

Conditions

Fontan Physiology

Age range

2 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

If it can be shown that changing the tidal volume does affect the blood flow to the lungs and cardiac output in patients with Fontan circulation the information can be used to learn from this study to optimize the tidal volume ventilation, and therefore pulmonary blood flow and cardiac output when Fontan patients come for general anesthesia. This is important because the population of patients with Fontan circulation is increasing and an increasing number will present for cardiac and non cardiac surgery when positive pressure ventilation will be required. They may also spend time on the cardiac intensive care unit on a ventilator and improving our knowledge on how best to ventilate them may help improve their overall hospital outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 2- 50 years of age
  • Patients with Fontan circulation undergoing cardio-thoracic surgery or undergoing cardio-thoracic surgery for completion of Fontan circulation.

Exclusion criteria

  • Patients presenting for cardio-thoracic surgery without Fontan circulation or those not coming for completion of Fontan circulation.

Treatment and study plan

Small volume breath and fast breathing rate for 5 minutes

Other

Small volume breath and fast breathing rate delivered via mechanical ventilator.

Large volume breath and slow breathing rate for 5 minutes

Other

Large volume breath and slow breathing rate delivered via mechanical ventilator.

Primary outcomes

  1. Transpulmonary gradient

    Time frame: 5 minutes of change in Tidal Volume (high vs low)

    Effect of tidal volume changes (high vs low) on Transpulmonary gradient as measured as the difference between mean pulmonary artery pressure measured from right internal jugular (Fontan pressure line) and left atrial pressure measured by direct intracardiac pressure line. Both lines are placed for the scheduled clinical procedure and not solely for the purposes of the research study.

Secondary outcomes

  1. Blood flow in inferior vena cava (IVC)

    Time frame: 5 minutes of change in Tidal Volume (high vs low)

    Effect of tidal volume changes (high vs low) on blood flow in inferior vena cava (IVC) as measured by Transesophageal Echocardiography TEE)..

  2. Systemic outflow tract stroke distance (velocity time integral)

    Time frame: 5 minutes of change in Tidal Volume (high vs low)

    Effect of tidal volume changes (high vs low) on systemic outflow tract stroke distance (velocity time integral) as measured by Transesophageal Echocardiography. (TEE).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2020
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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