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

Fontan Physiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633343
• Other study ID #: 58526
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: May 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Age 2- 50 years of age

2. Patients with Fontan circulation undergoing cardio-thoracic surgery or undergoing cardio-thoracic surgery for completion of Fontan circulation.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fontan Physiology

Intervention

Other:
• Small volume breath and fast breathing rate for 5 minutes
Small volume breath and fast breathing rate delivered via mechanical ventilator.
• Large volume breath and slow breathing rate for 5 minutes
Large volume breath and slow breathing rate delivered via mechanical ventilator.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transpulmonary gradient	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.	5 minutes of change in Tidal Volume (high vs low)
Secondary	Blood flow in inferior vena cava (IVC)	Effect of tidal volume changes (high vs low) on blood flow in inferior vena cava (IVC) as measured by Transesophageal Echocardiography TEE)..	5 minutes of change in Tidal Volume (high vs low)
Secondary	Systemic outflow tract stroke distance (velocity time integral)	Effect of tidal volume changes (high vs low) on systemic outflow tract stroke distance (velocity time integral) as measured by Transesophageal Echocardiography. (TEE).	5 minutes of change in Tidal Volume (high vs low)