Neurophysiological Monitoring and Videolaryngoscopy

Neurophysiological Monitoring During Videolaryngoscopy and Tracheal Intubation in Patient With Unstable Cervical Spine: A Prospective, Interventional, Cohort Study

Myopathic patients undergoing cervical spine surgery are at risk for postoperative neurological deficits and sequelae.

Awake fiberoptic intubation is considered the technique of choice for tracheal intubation in patient with cervical spine instability. However, awake fiberoptic intubation frequently causes significant patient discomfort, requires patient cooperation, anesthesiologist expertise and the availability of costly equipment .

Videolaryngoscopy guided intubation is considered to be an effective alternative to awake fiberoptic intubation for cervical spine surgeries.

Intraoperative neurophysiological monitoring (IONM) is a method that provides real time evaluation of the functional integrity of neural structures. The goal of IONM is to make surgery safer by detecting incipient neurological insults at a time when it can be avoided or minimized and by aiding in the identification of neural structure Rayia, et al. have described a case of monitoring intubation and neck extension for the indication of thyroidectomy in a Down syndrome boy with atlantoaxial instability under anesthesia with propofol and remifentanil without neuromuscular blockade. The authors conclude that this approach can be used to protect against spinal cord compression.

While research has thoroughly evaluated the effect of laryngoscopy and intubation on cervical spine movement, to date, little is known about the impact of intubation process on neurophysiological responses, and on the feasibility of utilizing IONM for establishing a safe airway intubation.

This prospective, interventional, cohort study is the first, to our knowledge, to examine the feasibility and added benefits of IONM throughout anesthetic intubation in patients undergoing cervical spine surgeries with the use of videolarynscope guided intubation.

Study Overview

• Status: Recruiting
• Conditions: Postsynaptic Potential Summation
• Intervention / Treatment: Procedure: Neurophysiological monitoring during intubation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leonid Eidelman; Phone Number: 97239376850; Email: leidelman@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical Center/Beilinson Campus
    • Sub-Investigator: Binyamin Yafa Zerbi, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All patients above 18y old, presenting for cervical spine surgeries , suffering from cervical spine instability, whom are able to comply with the study requirements and gave a written informed consent will be eligible for study enrollment.

Exclusion Criteria:

• Patients presenting with heart disease will not be eligible to participate.
• Patients with anticipated difficult airway.
• Patients with a language barrier.
• Patients with known allergy to any of the drugs used.
• Pregnant women
• Patients with a history of seizures or CVA.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neurophysiological monitoring during induction

Procedure: Neurophysiological monitoring during intubation; In the operating room patients will be connected to the anesthesia monitor and an IV line as standard clinical practice. Participants will receive oxygen and an IV infusion of 1-3 ng/ml remifentanil via TCI infusion pump to achieve mild sedation. Patients will then be connected to the neurophysiological electrodes to monitor for EEG, EMG, SSEP and MEP signals. After preparing the videolaryngoscope, anesthesia induction will be achieved with the use of IV ketamine 2mg/kg. Then the anesthesiologist will perform a clinical and ECG reading assessment to ensure that the patient is anesthetized and will be able to titrate more ketamine as needed to achieve hypnosis. A biteblock will be located to prevent teeth damage. A neurophysiological baseline recordings will then be performed by a neurophysiologist. The videolaryngoscope will then be inserted, during which a second neurophysiological testing will be performed to ensure the patients safety. Then mechanical ventilation will be initiated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Differences is somatosensory evoked potentials and motor evoked potentials signals during intubation	During surgery

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Leonid O Eidelman, Rabin Medical Center

Publications and helpful links

General Publications

• Stecker MM. A review of intraoperative monitoring for spinal surgery. Surg Neurol Int. 2012;3(Suppl 3):S174-87. doi: 10.4103/2152-7806.98579. Epub 2012 Jul 17.
• Epstein NE. The need to add motor evoked potential monitoring to somatosensory and electromyographic monitoring in cervical spine surgery. Surg Neurol Int. 2013 Oct 29;4(Suppl 5):S383-91. doi: 10.4103/2152-7806.120782. eCollection 2013.
• Dutta K, Sriganesh K, Chakrabarti D, Pruthi N, Reddy M. Cervical Spine Movement During Awake Orotracheal Intubation With Fiberoptic Scope and McGrath Videolaryngoscope in Patients Undergoing Surgery for Cervical Spine Instability: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Jul;32(3):249-255. doi: 10.1097/ANA.0000000000000595.
• Nunes RR, Bersot CDA, Garritano JG. Intraoperative neurophysiological monitoring in neuroanesthesia. Curr Opin Anaesthesiol. 2018 Oct;31(5):532-538. doi: 10.1097/ACO.0000000000000645.
• Al Bahri RS, MacDonald DB, Mahmoud AH. Motor and somatosensory evoked potential spinal cord monitoring during intubation and neck extension for thyroidectomy in a Down syndrome boy with atlantoaxial instability. J Clin Monit Comput. 2017 Feb;31(1):231-233. doi: 10.1007/s10877-016-9832-x. Epub 2016 Jan 28.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Anticipated): December 21, 2022
• Study Completion (Anticipated): February 21, 2023

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 1, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 0534-20-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No