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Contemp Clin Trials Commun. 2020 Feb 19;17:100545. doi: 10.1016/j.conctc.2020.100545. eCollection 2020 Mar.

Neurophysiological and paraspinal oximetry monitoring to detect spinal cord ischemia in patients during and after descending aortic repair: An international multicenter explorative study.

Contemporary clinical trials communications

Cheryl N Oostveen, Patrick W Weerwind, Paul P E Bergs, Jürg Schmidli, Roman Bühlmann, Joerg C Schefold, Balthasar Eberle, Jolanda Consiglio, Gereon Schälte, Drosos Kotelis, Angelique W H Hollands, Wolfgang F F A Buhre, Geert Willem H Schurink, Michael J Jacobs, Walther N K A van Mook, Werner H Mess, Nadia A Sutedja

Affiliations

  1. Maastricht University Medical Center, P. Debyelaan 25, 6229, HX, Maastricht, the Netherlands.
  2. University Hospital Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.
  3. Uniklinik RWTH Aachen, Pauwelsstraße 30, 52074, Aachen, Germany.

PMID: 32181411 PMCID: PMC7063092 DOI: 10.1016/j.conctc.2020.100545

Abstract

BACKGROUND: During descending aortic repair, critically decreased blood flow to the myelum can result in ischemic spinal cord injury and transient or permanent paraplegia. Assessment of motor evoked potentials (MEPs) has been shown to be a valuable tool which allows to detect spinal cord ischemia (SCI) intraoperatively within a therapeutic window suitable to prevent progression to paraparesis or paraplegia. MEP monitoring is not feasible during postoperative care in the awakening patient. Therefore, ancillary techniques to monitor integrity of spinal cord function are needed to detect delayed spinal cord ischemia.

OBJECTIVE: The purpose of this study is to evaluate whether assessment of long loop reflexes (LLR; F-waves) and paraspinal muscle oximetry using Near-Infrared Spectroscopy (NIRS) are feasible and valid in detecting delayed SCI.

METHODS: We aim to include patients from three tertiary referral centers undergoing aortic repair with MEP monitoring in this study.F-wave measurements and paraspinal NIRS oximetry will be operated intra- and postoperatively. Measurement characteristics and feasibility will be assessed in the first 25 patients. Subsequently, a second cohort of 75 patients will be investigated to determine the sensitivity and specificity of F-waves and NIRS in detecting perioperative SCI. In this context for the MEP group SCI is defined intraoperatively as significant MEP changes and postoperatively as newly developed paraplegia.

CONCLUSIONS: A clinical study design and protocol is proposed to assess if F-waves and/or NIRS-based paraspinal oximetry are feasible and valid in detecting and monitoring for occurrences of delayed SCI.

© 2020 The Authors.

Keywords: Descending aortic repair; NIRS oximetry; Neurophysiological monitoring techniques; Spinal cord ischemia; Thoracoabdominal aortic aneurysm repair

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