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Fontan Physiology Ventilation Strategy

Primary Purpose

Anesthesia, Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Vt protocol
High Vt protocol
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UPMC Children's Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low transition to High Vt protocol

High transition to Low Vt protocol

Arm 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.

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.

Outcomes

Primary Outcome Measures

Cardiac Output
The investigators will assess cardiac output using the Fink principle for each arm of randomization.

Secondary Outcome Measures

Pulmonary blood flow
The investigators will compare blood flow in both arms.
Systemic blood pressure
The investigators will assess the vital sign in both intervention arms.
Pulmonary arterial pressure
The investigators will assess pressures in both intervention arms.
Pulmonary vascular resistance
Completed using pulmonary vascular resistance (PVR) equation from measurements obtained during the cardiac catheterization.
Systemic vascular resistance
This will be calculated using appropriate equations using measurement obtained during catheterization procedure.

Full Information

First Posted
December 8, 2020
Last Updated
May 15, 2023
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT04672538
Brief Title
Fontan Physiology Ventilation Strategy
Official Title
Impact of Fontan Ventilation Strategy on Cardiac Output: An Invasive Physiologic Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
March 14, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Congenital Heart Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The trial will be a randomized crossover design.
Masking
None (Open Label)
Masking Description
Randomized cross over
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low transition to High Vt protocol
Arm Type
Experimental
Arm 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.
Arm Title
High transition to Low Vt protocol
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Low Vt protocol
Intervention Description
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
Intervention Name(s)
High Vt protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac Output
Description
The investigators will assess cardiac output using the Fink principle for each arm of randomization.
Time Frame
Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Secondary Outcome Measure Information:
Title
Pulmonary blood flow
Description
The investigators will compare blood flow in both arms.
Time Frame
Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Title
Systemic blood pressure
Description
The investigators will assess the vital sign in both intervention arms.
Time Frame
Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Title
Pulmonary arterial pressure
Description
The investigators will assess pressures in both intervention arms.
Time Frame
Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Title
Pulmonary vascular resistance
Description
Completed using pulmonary vascular resistance (PVR) equation from measurements obtained during the cardiac catheterization.
Time Frame
Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Title
Systemic vascular resistance
Description
This will be calculated using appropriate equations using measurement obtained during catheterization procedure.
Time Frame
Measurements will occur at the 5-minute equilibration period into the ventilation strategy.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip S Adams, DO
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9403618
Citation
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.
Results Reference
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Fontan Physiology Ventilation Strategy

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