Impact of Fontan Ventilation Strategy on Cardiac Output: An Invasive Physiologic Cross-over Study

  • End date
    Nov 23, 2023
  • participants needed
  • sponsor
    University of Pittsburgh
Updated on 23 October 2022
assisted ventilation


This study will investigate the different tidal volume (Vt) strategies during a cardiac catheterization procedure to determine whether or not low or high Vt have an impact on cardiac output.

Research question: While maintaining the same minute ventilation/PaCO2, does higher Vt (10 cc/kg)/lower rate vs. lower Vt (6 cc/kg)/higher rate (maintaining consistent PEEP) result in improved cardiac output?


The trial will be a randomized crossover design. The study cohort will be randomized (50/50) to begin with either low Vt or high Vt ventilation. After achieving steady state, initial cardiac output measurements will be made using a measured oxygen consumption (VO2) and the Fick principle, per routine clinical protocol. Following baseline assessment of cardiac output and hemodynamics (which is standard of care for all catheterization procedures), participants will be transitioned to the alternative ventilation modality (high Vt or low Vt). After a 5-minute equilibration period, oxygen saturations and VO2 measurements will be re-acquired, to determine cardiac output and hemodynamics in this second state.

Condition Anesthesia, Congenital Heart Disease
Treatment Low Vt protocol, High Vt protocol
Clinical Study IdentifierNCT04672538
SponsorUniversity of Pittsburgh
Last Modified on23 October 2022


Yes No Not Sure

Inclusion Criteria

Patients of UPMC Children's Hospital of Pittsburgh that have Fontan physiology (single heart ventricle) that are presenting as outpatients to undergo a cardiac catheterization with general endotracheal anesthesia for purpose of diagnosis or interventional cath
Parents and/or guardians willing to provide informed consent

Exclusion Criteria

Those unwilling to give consent and those patients who do not have Fontan physiology
Any urgent/emergent catheterization procedure will be excluded
Any Fontan patient having a cardiac catheterization under monitored anesthesia care (as opposed to general endotracheal anesthesia) will not be eligible
Inability to undergo cardiac catheterization
Pregnant women will be excluded
< 6 weeks post-op from Fontan completion surgery
Same hospitalization as Fontan completion surgery
Intrinsic pulmonary disease which would be anticipated to impact study protocol / findings
Fontan completion surgery performed at age > 7 years
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