NCT04672538

Fontan Physiology Ventilation Strategy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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?

Detailed 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.

Conditions

• Anesthesia
• Congenital Heart Disease

Interventions

Type	Name	Description
PROCEDURE	Low Vt protocol	Low Vt protocol - tidal volumes (Vt) 6 ml/kg, respiratory rate required for end tidal carbon dioxide (EtCO2) of 36-38 mmHg, PEEP 5 centimeter of water (cm-H20) , I:E ratio 1:2
PROCEDURE	High Vt protocol	High Vt protocol - tidal volumes (Vt) 10 ml/kg, respiratory rate required for EtCO2 of 36-38 mm Hg, PEEP 5 cmH2O, I:E ratio 1:3.

Timeline

• Start date: 2021-03-02
• Primary completion: 2023-03-14
• Completion: 2023-05-15
• First posted: 2020-12-17
• Last updated: 2023-05-17

Locations

1 site across 1 country: United States