Fontan Physiology Ventilation Strategy

NCT ID: NCT04672538

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2023-05-15

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?

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low Vt protocol

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Low Vt protocol

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Phillip S. Adams, DO

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Phillip S Adams, DO

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 9403618 (View on PubMed)

Other Identifiers

STUDY20100012

Identifier Type: -

Identifier Source: org_study_id