Impact of Fontan Ventilation Strategy on Cardiac Output: An Invasive Physiologic Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Cardiac Output
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Randomized cross over
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Cardiac Output
时间窗: 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.
次要结局
- Pulmonary blood flow(Measurements will occur at the 5-minute equilibration period into the ventilation strategy.)
- Pulmonary vascular resistance(Measurements will occur at the 5-minute equilibration period into the ventilation strategy.)
- Pulmonary arterial pressure(Measurements will occur at the 5-minute equilibration period into the ventilation strategy.)
- Systemic blood pressure(Measurements will occur at the 5-minute equilibration period into the ventilation strategy.)
- Systemic vascular resistance(Measurements will occur at the 5-minute equilibration period into the ventilation strategy.)
研究者
Phillip S. Adams, DO
Assistant Professor of Anesthesiology
University of Pittsburgh