NCT06812975已完成不适用
Early Identification of Right Ventricular Dysfunction and Failure in Cardiothoracic and Liver Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Arterial waveform
研究概览
简要总结
In association with Edwards LifeSciences, the study will aim to develop an algorithm based on right heart (right atrial, right ventricular and pulmonary artery) waveforms for the early detection of RV dysfunction in cardiothoracic and liver surgery patients at UMMC. This is a prospective, non-interventional, observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be ≥ 18 years of age presenting to the University of Minnesota Medical Center undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation
- •Participate in the Informed Consent process and sign/date the approved informed consent forms
- •Projected to receive Swan-Ganz paceport catheter as part of procedure/standard of care with intermittent cardiac output and mixed venous oxygen saturation (SvO2) measures
排除标准
- •Patients with a history of internal jugular vein thrombosis or known reasons for not being able to thread a central venous catheter through either internal jugular vein
- •Patients with a history of known esophageal strictures, esophageal or stomach cancer, esophageal varices, or any patient in whom a TEE is contraindicated
- •Patients with permanent pacemakers whose right ventricle is being paced and not in normal sinus rhythm
- •Patients unable to consent to participating in the study
- •Patients who are pregnant will be excluded, as part of standard care, all female patients are screened for pregnancy prior to surgery
- •Patients under the age of 18 years old
- •Patients with left bundle branch block, recurrent sepsis, or hypercoagulopathy
- •Patients allergic to FORE-SIGHT Elite sensor adhesive
- •Patients with latex allergy due to presence of latex in the Swan-Ganz catheter balloon.
结局指标
主要结局
Arterial waveform
时间窗: 24 hours postoperative
The slope of the diastolic right ventricular waveform which includes measures of RV end-diastolic pressure and RV contractility (dPdt)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Unmasking Right Ventricular and Pulmonary Derangements With Exercise and Oxygen in Early Stage Cardiopulmonary DiseasesCardiopulmonary DiseaseNCT03911856Mayo Clinic7
已完成
不适用
Diagnostic Investigation of Sudden Cardiac Event RiskCardiovascular DiseasesHeart FailureArrhythmiaCVDNCT00500708CardioDx1,564
已完成
不适用
Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain InjuryTraumatic Brain InjuryNCT05084352University of Maryland, Baltimore1,200
招募中
不适用
Exercise Right Ventricular Coupling in HFpEFHeart Failure With Preserved Ejection FractionPulmonary HypertensionNCT05731466Universitaire Ziekenhuizen KU Leuven30
已完成
不适用
HeartTrends Heart Rate Variability (HRV) Algorithm for the Diagnosis of Myocardial IschemiaIschemic Heart DiseaseNCT01657006Sheba Medical Center450