Fontan Physiology Ventilation Strategy

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672538
• Other study ID #: STUDY20100012
• Status: Completed
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: May 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 15, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

Shekerdemian LS, Bush A, Shore DF, Lincoln C, Redington AN. Cardiopulmonary interactions after Fontan operations: augmentation of cardiac output using negative pressure ventilation. Circulation. 1997 Dec 2;96(11):3934-42. doi: 10.1161/01.cir.96.11.3934. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output	The investigators will assess cardiac output using the Fink principle for each arm of randomization.	Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Secondary	Pulmonary blood flow	The investigators will compare blood flow in both arms.	Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Secondary	Systemic blood pressure	The investigators will assess the vital sign in both intervention arms.	Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Secondary	Pulmonary arterial pressure	The investigators will assess pressures in both intervention arms.	Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Secondary	Pulmonary vascular resistance	Completed using pulmonary vascular resistance (PVR) equation from measurements obtained during the cardiac catheterization.	Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Secondary	Systemic vascular resistance	This will be calculated using appropriate equations using measurement obtained during catheterization procedure.	Measurements will occur at the 5-minute equilibration period into the ventilation strategy.