Fontan Physiology Ventilation Strategy

• ClinicalTrials.gov Identifier: NCT04672538
• Recruitment Status: Recruiting
• First Posted: December 17, 2020
• Last Update Posted: March 8, 2022
• Sponsor: University of Pittsburgh
• Information provided by (Responsible Party): Phillip S. Adams, DO, University of Pittsburgh

Study Description

Brief 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?

Condition or disease	Intervention/treatment	Phase
Anesthesia; Congenital Heart Disease	Procedure: Low Vt protocol; Procedure: High Vt protocol	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: The trial will be a randomized crossover design.
• Masking: None (Open Label)
• Masking Description: Randomized cross over
• Primary Purpose: Supportive Care
• Official Title: Impact of Fontan Ventilation Strategy on Cardiac Output: An Invasive Physiologic Cross-over Study
• Actual Study Start Date: March 2, 2021
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: October 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Low transition to High Vt protocol; 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.	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.
Experimental: High transition to Low Vt protocol; 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Cardiac Output [ Time Frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy. ]
   The investigators will assess cardiac output using the Fink principle for each arm of randomization.

Secondary Outcome Measures :

1. Pulmonary blood flow [ Time Frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy. ]
   The investigators will compare blood flow in both arms.
2. Systemic blood pressure [ Time Frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy. ]
   The investigators will assess the vital sign in both intervention arms.
3. Pulmonary arterial pressure [ Time Frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy. ]
   The investigators will assess pressures in both intervention arms.
4. Pulmonary vascular resistance [ Time Frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy. ]
   Completed using pulmonary vascular resistance (PVR) equation from measurements obtained during the cardiac catheterization.
5. Systemic vascular resistance [ Time Frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy. ]
   This will be calculated using appropriate equations using measurement obtained during catheterization procedure.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Phillip S Adams, DO; 412-692-4503; adamsp@upmc.edu

Contact: Bryan Goldstein, MD; 412-692-6903; bryan.goldstein@chp.edu

Locations

United States, Pennsylvania

UPMC Children's Hospital of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contact: Philip Adams, DO 412-692-4503 adamsp@upmc.edu

Contact: David Groscost, RN 412-864-8655 david.groscost@chp.edu

Principal Investigator: Philip Adams, DO

Sponsors and Collaborators

University of Pittsburgh

Investigators

• Principal Investigator: Phillip S Adams, DO; University of Pittsburgh

More Information

Publications:

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.

• Responsible Party: Phillip S. Adams, DO, Assistant Professor of Anesthesiology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04672538
• Other Study ID Numbers: STUDY20100012
• First Posted: December 17, 2020
• Last Update Posted: March 8, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Diseases; Heart Defects, Congenital; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities