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NCT04576637
Neurophysiological Monitoring and Videolaryngoscopy
NA trial testing Neurophysiological monitoring during intubation in Postsynaptic Potential Summation in 20 participants. Status unknown.
21 December 2022
Quick facts
| Lead sponsor | Rabin Medical Center |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 20 |
| Start date | 21 October 2020 |
| Primary completion | 21 December 2022 |
| Estimated completion | 21 February 2023 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Neurophysiological monitoring during intubation
Conditions studied
- Postsynaptic Potential Summation — all drugs for Postsynaptic Potential Summation →
Sponsor
Rabin Medical Center
Who can join
18 and older, any sex, with Postsynaptic Potential Summation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04576637 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rabin Medical Center
- Last refreshed: 3 May 2022
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