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…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study will consist of two parts. Part one refers to the *intraoperative
phase*, the period when patients are fully sedated. This contains the whole
period during surgery. Part two refers to the *postoperative phase*, the period
after surgery when patients are fully sedated and when the level of sedation
has been decreased and patients are only partially sedated and eventually
awake.
1. During part one, the *intraoperative phase*, feasibility of the techniques
described above will be determined and characteristics will be described. An
association with the current gold standard (MEP signals) will be determined.
2. During part two, the *postoperative phase*, feasibility of the techniques
described above will be determined and characteristics will be described. An
association with hemodynamic characteristics as well as paraparesis at the end
of the postoperative period (after the patient wakes up) will be determined.
Secondary outcome
As described in section above.
Background 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 unanesthesized or
partially anesthesized 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).
Study objective
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 unanesthesized or partially anesthesized patient and
therefore can also be performed postoperatively.
The following candidate tests will be examined:
1. Oxygenation measurements of the paraspinal muscles using Near-infrared
spectroscopy (NIRS).
Study design
Feasibility study.
Study burden and risks
There is no risk associated with participation in the study and the study is
non-therapeutic. Intraoperatively, the patient is fully sedated and the burden
is comparable to the standard care (intraoperative neuromonitoring).
Postoperatively, during the period that the patient is fully sedated,
additional burden of the measurements will be minimal.
There may be discomfort due to permanent attachment of optodes to the skin
overlying the paraspinal muscles. If any skin changes are noticed, this will be
documented and if necessary the measurements will be discontinued.
Clinical and neurological examination is performed as in standard patient care.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 years
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
Age < 18 years.
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58137.068.16 |