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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2022-08-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Fontan Physiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Small Volume Breath Group (5mlKg)

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

Group Type EXPERIMENTAL

Small volume breath and fast breathing rate for 5 minutes

Intervention Type OTHER

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

Large Volume Breath Group (10mL/kg)

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

Group Type EXPERIMENTAL

Large volume breath and slow breathing rate for 5 minutes

Intervention Type OTHER

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

Interventions

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Small volume breath and fast breathing rate for 5 minutes

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

Intervention Type OTHER

Large volume breath and slow breathing rate for 5 minutes

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

Intervention Type OTHER

Eligibility Criteria

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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.