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

Stanford University

Status: Completed

Conditions: Fontan Physiology

Treatments: Other: Large volume breath and slow breathing rate for 5 minutes; Other: Small volume breath and fast breathing rate for 5 minutes

Study type: Interventional

Funder types: Other

Identifiers

NCT04633343

58526

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 2 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Small Volume Breath Group (5mlKg)

Experimental group

Description:

Small volume breath and fast breathing rate for 5 minutes when the patient is in the Operating room and on mechanical ventilation

Treatment:

Other: Small volume breath and fast breathing rate for 5 minutes

Large Volume Breath Group (10mL/kg)

Experimental group

Description:

Large volume breath and slow breathing rate for 5 minutes when the patient is in the Operating room and on mechanical ventilation.

Treatment:

Other: Large volume breath and slow breathing rate for 5 minutes