Evaluating Monitoring Techniques for Postoperative Spinal Cord Ischemia (SINATRA)

  • STATUS
    Recruiting
  • days left to enroll
    82
  • participants needed
    100
  • sponsor
    Maastricht University Medical Center
Updated on 24 April 2022

Summary

During open surgery of a thoraco-abdominal aortic aneurysma (TAAA), diminished blood flow to the myelum can result in hypoxia, compromising proper function of the spinal cord.

Intraoperatively, motor evoked potentials (MEP) are elicited to measure the functional integrity of the spinal cord. MEPs have proven to be a reliable marker of spinal cord ischemia. Moreover, these potentials react within minutes, which facilitates interventions to restore the blood flow. Monitoring intraoperatively with this ancillary test has reduced the rate of paraparesis to < 5%. Unfortunately, in the early postoperative period, spinal cord vulnerability is high. Therefore, some patients develop paraparesis, not during the surgical procedure, but after the surgical procedure. Postoperatively, suboptimal blood flow may lead to critical loss of function. This inadequate perfusion results in "delayed paraparesis". In the postoperative patient, it is not possible to measure MEPs when sedation is decreased, due to the high intensity of the electrical stimulus, which is unacceptably painful in the unanesthetized or partially anesthetized patient. Therefore ancillary tests are needed which can detect spinal cord ischemia postoperatively early, thus preceding the phase with clinically overt paraparesis. The test should be reliable and easy to perform for an extended period of time (up to several days).

The purpose of this study is to explore the usefulness of various neurophysiological tests regarding accuracy and feasibility for the detection of spinal cord ischemia. In particular, to find a diagnostic test which is acceptable for the unanesthetized or partially anesthetized patient and therefore can also be performed postoperatively. These tests will be examined in fully sedated as well as partially sedated patients.

The following candidate tests will be examined:

  1. Long loop reflexes (LLR) consisting of F-waves.
  2. Oxygenation measurements of the paraspinal muscles using Near-infrared spectroscopy (NIRS).

Details
Condition Monitoring, Postoperative, Spinal Cord Ischemia, Thoracoabdominal Aneurysm, TAAA, NIRS, Long Loop Reflexes, F-waves
Treatment Near-infrared spectroscopy, Long loop reflex measurements
Clinical Study IdentifierNCT03074487
SponsorMaastricht University Medical Center
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Thoraco-abdominal aneurysm (TAA) of the descending aorta: Crawford type I,II, III, IV or V
Repair using open surgical or endovascular procedure
Undergoing monitoring by motor evoked potentials (MEP) as part of the standard surgical procedure

Exclusion Criteria

Aneurysm only in ascending part of the aorta
Standard contraindications for motor evoked potential (MEP) monitoring
Standard contraindications for electrode placement (skin wounds, etc.)
No informed consent can be obtained prior to the procedure
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note