A phase III sTudy evaluating the efficacy and safety of Trans-Esophageal Motor-evoked PoTential monitoring and the special electrode during aortic surgery - ATTEMPT

orihiko Shiiya0 个研究点目标入组 100 人开始时间: 2023年12月15日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•1) patients scheduled to undergo aortic surgery carrying the risk of ischemic spinal cord injury and TC-MEP
•2) patients aged 20 years or more on the day of giving informed consent
•3) patients giving written informed consent to be enrolled in this trial

•Patients meeting any of the following exclusion criteria on the day of enrollment are excluded.
•1) patients undergoing aortic surgery within 24 hours after non-scheduled admission
•2) patients having esophageal abnormality (severe compression or deviation causing esophageal obstruction by tumors or something else, esophageal varices with a arisk of bleeding, esophagus not locating in the normal anatomical position at theT4 level such as post-esophageal surgery, etc)
•3) patients having head skin abnormality (resulting in difficulty of setting the transcranial stimuation elecrodes) at the stimulation points
•4) patients having paralysis (such as hemiplegia or paraplegia) or neuromusclar diseases with severe
•5) patients unable to walk without assistance due to prolonged bed rest or some other reasons
•6) patients judged unsuitable by the investigators or subinvstigators

发起方

orihiko Shiiya