Status:
COMPLETED
Fontan Physiology Ventilation Strategy
Lead Sponsor:
University of Pittsburgh
Conditions:
Anesthesia
Congenital Heart Disease
Eligibility:
All Genders
Phase:
NA
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...
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 me...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04672538
Start Date
March 2 2021
End Date
May 15 2023
Last Update
May 17 2023
Active Locations (1)
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1
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224