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Neurophysiological Monitoring and Videolaryngoscopy

1. maj 2022 opdateret af: Leonid Eidelman, Rabin Medical Center

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Petach Tikva, Israel, 49100
        • Rekruttering
        • Rabin Medical Center/Beilinson Campus
        • Underforsker:
          • Binyamin Yafa Zerbi, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Neurophysiological monitoring during induction
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Differences is somatosensory evoked potentials and motor evoked potentials signals during intubation
Tidsramme: During surgery
During surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Leonid O Eidelman, Rabin Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. oktober 2020

Primær færdiggørelse (Forventet)

21. december 2022

Studieafslutning (Forventet)

21. februar 2023

Datoer for studieregistrering

Først indsendt

22. september 2020

Først indsendt, der opfyldte QC-kriterier

29. september 2020

Først opslået (Faktiske)

6. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 0534-20-RMC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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