Fontan Physiology Ventilation Strategy

University of Pittsburgh

Status: Completed

Conditions: Congenital Heart Disease; Anesthesia

Treatments: Procedure: High Vt protocol; Procedure: Low Vt protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04672538

STUDY20100012

Details and patient eligibility

About

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?

Full description

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.

Enrollment: 32 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Low transition to High Vt protocol

Experimental group

Description:

This arm of the study will begin with lower tidal volumes at higher respiratory rates for initial hemodynamic measurements. They will then be transitioned to the higher tidal volume at lower respiratory rate condition for repeat hemodynamic measurement.

Treatment:

Procedure: Low Vt protocol

Procedure: High Vt protocol

High transition to Low Vt protocol

Experimental group

Description:

This arm of the study will begin with higher tidal volumes at lower respiratory rates for initial hemodynamic measurements. They will then be transitioned to the lower tidal volume at higher respiratory rate condition for repeat hemodynamic measurement.

Treatment:

Procedure: Low Vt protocol

Procedure: High Vt protocol