Dose Responsiveness as a Measure of Clinical Effectiveness During Neuromonitored Spine Surgery

• Conditions: Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Spinal Stenosis; Spinal Curvatures; Spondylitis; Spondylosis

• Registration Number: NCT05110833
• Lead Sponsor: Allina Health System

Brief Summary

Intraoperative Neuromonitoring (IONM) is a tool used by neurophysiologists during spine surgery to prevent irreversible damage to the spinal cord during procedures through a system of alerts. This study investigates the effectiveness of IONM in 300 participants receiving spine surgery. The goal of this study is to refine the alert criteria for procedures in which IONM is used.

Detailed Description

Intraoperative neurophysiological monitoring (IONM) measures neural function and integrity during surgical procedures. Through IONM, neurodiagnostic procedures can help determine whether any nerves have become compressed or if the brain or spinal cord has any reduced vascular flow, allowing the surgical team to take immediate and corrective actions to prevent a bad outcome. Essentially, IONM acts as an early warning system for surgeons to gain reliable insight into a patient's condition during surgery, adding a layer of safety to the measures already in place that monitor cardiac and respiratory function while a patient is anesthetized.

We propose an observational research study to enhance the evidence-base for IONM. A novel prospective neuromonitoring database will be implemented. In addition to the usual contingency data to assess prediction accuracy, other measures will be examined:

1. A "dose effect of injury" assessment. Three categories of injury will be recorded by physicians: (a) No New Deficit; (b) New Minor Deficit; and (c) New Severe Deficit.

2. The outcome effect of intraoperative test frequency will be evaluated (infrequent vs average vs very frequent), leading to a "dose effect of neuromonitoring" assessment. Here we hypothesize that within our prospective sample, there is a relationship between the proportion of total new neurological deficits (New Minor Deficit + New Severe Deficit) and the frequency of IONM testing. More frequent testing is associated with fewer total new neurological deficits.

3. Patient reported outcomes will be evaluated longitudinally in conjunction with clinical outcomes data. Patient interviews will be conducted by a trained research assistant aided by department technologists. Patient-reported neurological outcome assessments will be supplemented/confirmed by review of in- and outpatient surgical/neurophysiologist physician chart notes.

Data from this proposed observational study will allow real-life outcomes based improvement in the field of IONM.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-11-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Must be 18+ years old
• Patients must be undergoing cervical and/or thoracic spine surgical procedure at Abbott Northwestern Hospital in Minneapolis, MN

Exclusion Criteria

• Patients who are non-English speakers
• Patients with ongoing psychiatric concerns are excluded
• Patients unwilling to be contacted for a 6-month follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nature of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions	1 day	Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuation in amplitude and/or frequency, will be recorded.
The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations.	1 day
Nature of changes in free-run smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulation and recording.	1 day	Smooth muscle EMG in response to stimulations and recordings will be monitored. Any changes in the EMG, as indicated by fluctuation in amplitude and/or frequency, will be recorded.

Secondary Outcome Measures

Name	Time	Method
Short Form (36) Health Survey	1 year	A self-report survey of patient health

Trial Locations

Locations (1)

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States