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

JRCT ID: jRCT2042230116

Registered date:15/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: patients undergoing aortic surgery carrying the risk of ischemic spinal cord injury
• Date of first enrollment: 09/02/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): The test product Transesophageal spinal cord stimulation electrode" is inserted into the esophagus to monitor TE-MEP, in addition to the TC-MEP as a usual care.

Outcome(s)

• Primary Outcome: diagnostic specificity for the neurological evaluation on awakening (within 18 hours after the conclusion of surgery) by the change in the amplitude of motor evoked potenstials at the conclusion of surgery

Secondary Outcome

diagnostic sensitivity for the neurological outcomes on the day 8 by the presence or absence of intraoperative change (including the transient one) in the amplitude of TC-MEP and TE-MEP
agreement between the intraoperative changes in the ampitude of TC-MEP and TE-MEP
baseline amplitude of TC-MEP and TE-MEP
stability of monitoring (requirements and frequency of repositioning the stimulation electrodes)
diagnostic sensitivity for the neurological evaluation on awakening (within 18 hours after the conclusion of surgery) by the change in the amplitude of motor evoked potenstials at the conclusion of surgery
diagnostic specificity for the neurological outcomes on the day 8 by the change in the amplitude of motor evoked potenstials at the conclusion of surgery
diagnostic sensitivity for the neurological outcomes on the day 8 by the change in the amplitude of motor evoked potenstials at the conclusion of surgery
diagnostic specificity for the neurological outcomes on the day 8 by the presence or absence of intraoperative change (including the transient one) in the amplitude of TC-MEP and TE-MEP
agreement between the neurological evaluation on awakening (within 18 hours after the conclusion of surgery) and the neurological outcomes on the day 8

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Norihiko Shiiya
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development