跳至主要内容
临床试验/NCT02340741
NCT02340741Unknown不适用

Assessing of Carbon Dioxide Insufflation on the Neurological Complications During Open Heart Operations

Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
334
试验地点
2
主要终点
postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination

研究概览

简要总结

Effect of intraoperative insufflation of carbon dioxide on the neurologic complications in the early postoperative period after open cardiac surgery.

详细描述

Arterial air embolism in cardiac surgery is not a rare complication, leading to neurological damage in the early postoperative period of 3-5%. Insufflation of carbon dioxide (CO2) into the operative field to prevent cerebral or myocardial damage by air embolism is reported since 1967 in open heart surgery (Selman MW et al. 1967).

Carbon dioxide fills the thoracic cavity by gravity and replaces air if adequately insufflated. Because solubility of CO2 is better than that of air, occlusion or flow disruption in arteries of the brain or the heart is thought to be diminished. Despite carefully performed deairing procedures as puncturing of the ascending aorta and cardiac massage, transcranial Doppler studies revealed large amounts of emboli during the first ejections of the beating heart (van der Linden J et al. 1991). In patiens with minimally invasive approach and redo valve surgery, deairing of the cardiac chambers has become more difficult.

Although the use of carbon dioxide when filling in the surgical field, as the prevention of air embolism reduces the number of intracardiac emboli according to transesophageal echocardiography there is no evidence of a sustained reduction in cerebrovascular events (G. Salvatore al. 2009).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to sign Informed Consent and Release of Medical Information forms
  • Age 18 - 70 years
  • Patients scheduled on cardiac surgery with opening cavities

排除标准

  • History of stroke and TIA
  • Significant carotid artery stenosis
  • Presence of initial severe encephalopathy
  • Re-clamping of the aorta
  • Emergency surgery

结局指标

主要结局

postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination

时间窗: 14 days

conducting tests: Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination

次要结局

  • hospital mortality(14 days)

研究者

发起方
Meshalkin Research Institute of Pathology of Circulation
申办方类型
Network
责任方
Sponsor

研究点 (2)

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