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Neurophysiological Monitoring and Videolaryngoscopy

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ClinicalTrials.gov Identifier: NCT04576637
Recruitment Status : Recruiting
First Posted : October 6, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Leonid Eidelman, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE September 22, 2020
First Posted Date  ICMJE October 6, 2020
Last Update Posted Date March 17, 2021
Actual Study Start Date  ICMJE October 21, 2020
Estimated Primary Completion Date October 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2020)
Differences is somatosensory evoked potentials and motor evoked potentials signals during intubation [ Time Frame: During surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurophysiological Monitoring and Videolaryngoscopy
Official Title  ICMJE Neurophysiological Monitoring During Videolaryngoscopy and Tracheal Intubation in Patient With Unstable Cervical Spine: A Prospective, Interventional, Cohort Study
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Postsynaptic Potential Summation
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Neurophysiological monitoring during induction
Intervention: Procedure: Neurophysiological monitoring during intubation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 21, 2021
Estimated Primary Completion Date October 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Leonid Eidelman 97239376850 leidelman@clalit.org.il
Contact: Atara Davis 972533321329 ataratdavis@gmail.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04576637
Other Study ID Numbers  ICMJE 0534-20-RMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Leonid Eidelman, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonid O Eidelman Rabin Medical Center
PRS Account Rabin Medical Center
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP