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

NCT04633343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-14

No results posted yet for this study

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.

Conditions

  • Fontan Physiology

Interventions

OTHER

Small volume breath and fast breathing rate for 5 minutes

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

OTHER

Large volume breath and slow breathing rate for 5 minutes

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

Sponsors & Collaborators

Principal Investigators

  • Manchula Navaratnam, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2022-08-30
Completion
2022-08-30

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04633343 on ClinicalTrials.gov