跳至主要内容
临床试验/NCT02614664
NCT02614664撤回不适用

Changes in Cerebral Oxygenation During Laparoscopy in Patients With Single Ventricle Anatomy

Roby Sebastian1 个研究点 分布在 1 个国家开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Change in cerebral oxygenation values

研究概览

简要总结

Patients with single ventricle physiology (hypoplastic left heart syndrome, tricuspid atresia) frequently have feeding difficulties necessitating procedures such as Nissen fundoplication and G-tube placement. With advances in minimally invasive surgery, these are frequently performed using laparoscopic techniques. Although generally safe and effective, the increase in IAP during laparoscopy may increase systemic and pulmonary vascular resistance and decrease cardiac output. This prospective study will include 50 patients with single ventricle physiology presenting for laparoscopic procedures. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with single ventricle physiology presenting for laparoscopic procedures.

排除标准

  • 未提供

结局指标

主要结局

Change in cerebral oxygenation values

时间窗: From baseline to insufflation (average time frame of 30 mins. - 2 hrs.)

Measured on the NIRS cerebral oxygenation monitor attached to the patient.

次要结局

未报告次要终点

研究者

发起方
Roby Sebastian
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Roby Sebastian

Clinical Assistant Professor

Nationwide Children's Hospital

研究点 (1)

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