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C-MAC Videolaryngoscope Intubation and Cervical Spine Motion

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Seoul National University

Status

Unknown

Conditions

Intubation;Difficult
Cervical Spinal Cord Injury

Treatments

Device: C-MAC videolaryngoscope intubation
Device: Direct laryngoscope intubation

Study type

Interventional

Funder types

Other

Identifiers

NCT03567902
1804-123-940

Details and patient eligibility

About

The aim of the study is to compare the effect of the C-MAC videolaryngoscope intubation technique vs. the conventional direct laryngoscope intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization.

Full description

When the intubation is required in patients with an injured cervical spine, securing the airway while minimizing C-spine motion to prevent neurological damage can be very difficult. The awake intubation using a flexible bronchoscope is preferred as it minimizes C-spine motion. However, in the emergent clinical practice, direct laryngoscopy with manual in-line stabilization is most commonly used, because it is quicker and does not require patient collaboration. Numerous alternatives to direct laryngoscopy and fiberoptic bronchoscopy have been studied. But, none of these methods combines the convenience of direct laryngoscopy and the C-spine immobility afforded by intubation using a fiberoptic bronchoscope patient with an injured C-spine.

The videolaryngoscopy has recently developed extensively and become more widely available. It has the potential of combining the advantages of both direct laryngoscopy and intubation using a fiberoptic bronchoscope. Indeed, it provides an indirect view of the glottis, which could diminish C-spine movement, but its handling shares many similarities with direct laryngoscopy, which could make it more convenient than the flexible bronchoscope.

In the previous study examining C-spine movement during direct laryngoscopy and GlideScope® videolaryngoscopy, found no difference in movement at the rostral level but showed significantly less movement of the inferior C-spine with GlideScope® videolaryngoscopy. We postulate that C-MAC videolaryngoscope will induce less movement than direct laryngoscopy. The effect of C-MAC videolaryngoscope intubation technique on cervical spine motion is not investigated yet.

In this study, C-spine stabilization will be provided by Philadelphia neck collar. We will investigate a prospective cinefluoroscopic study comparing C-spine motion during direct laryngoscopy and C-MAC videolaryngoscope in patients with an intact C-spine stabilized by Philadelphia collar.

The duration and maximum change for C-MAC videolaryngoscope intubation technique was compared to those with direct laryngoscopy at each motion segment using a Student's paired t-test.

Enrollment

20 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with American Society of Anesthesiologists physical status of 1-2 and age of 20-80 years undergoing elective endovascular coiling to secure cerebral aneurysm under general anesthesia in neuroangiographic rooms.

Exclusion criteria

  • Patients with C-spine injury, C-spine disease
  • Patients with past medical history of C-spine surgery or intervention
  • Patients with the upper airway abnormalities, such as inflammation, abscesses, tumours, polyps, or trauma.
  • Patients with past medical history of gastro-oesophageal reflux disease and previous airway surgery, a high risk of aspiration, coagulation disorders, or Hunt Hess grade of 3-5.
  • Body mass index > 30

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 2 patient groups

Group A
Experimental group
Description:
C-MAC videolaryngoscope intubation -\> Direct laryngoscope intubation
Treatment:
Device: Direct laryngoscope intubation
Device: C-MAC videolaryngoscope intubation
Group B
Experimental group
Description:
Direct laryngoscope intubation -\> C-MAC videolaryngoscope intubation
Treatment:
Device: Direct laryngoscope intubation
Device: C-MAC videolaryngoscope intubation

Trial contacts and locations

0

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Central trial contact

Hee Pyung Park, MD PhD; Hyesun Paik, MD

Data sourced from clinicaltrials.gov

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