C-MAC Videolaryngoscope Intubation and Cervical Spine Motion

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03567902
Collaborator
(none)
20
2
11

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: C-MAC videolaryngoscope intubation
  • Device: Direct laryngoscope intubation
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
A Randomized Trial on Comparison of Cervical Spine Motion During Tracheal Intubation Using Direct Laryngoscope Versus C-MAC Videolaryngoscope in Simulated Immobilized Cervical Spine
Anticipated Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

C-MAC videolaryngoscope intubation -> Direct laryngoscope intubation

Device: C-MAC videolaryngoscope intubation
C-MAC videolaryngoscope intubation

Device: Direct laryngoscope intubation
Direct laryngoscope intubation

Experimental: Group B

Direct laryngoscope intubation -> C-MAC videolaryngoscope intubation

Device: C-MAC videolaryngoscope intubation
C-MAC videolaryngoscope intubation

Device: Direct laryngoscope intubation
Direct laryngoscope intubation

Outcome Measures

Primary Outcome Measures

  1. Maximum cervical spine motion (degree) [During tracheal intubation time, an expected average of 90 seconds]

    Maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments

Secondary Outcome Measures

  1. Intubation time [Within 90 seconds from insertion of device]

    Check the intubation time (seconds) defines 'from insertion of device to oral cavity of patients to confirm successful intubation'

  2. Number of intubation trial [During tracheal intubation time, an expected average of 1 minutes]

    Check the number of intubation trial

  3. Postoperative complications [During PACU stay time expected up to 1 hr]

    Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score

  4. Postoperative complications [24 hr after operation]

    Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score

  5. Postoperative complications [After extubation, immediate postoperative period]

    Blood tinged endotracheal tube ( yes or no)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: 82-2- 2072-2469 Park, Park, Seoul National University of Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hee-Pyoung Park, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT03567902
Other Study ID Numbers:
  • 1804-123-940
First Posted:
Jun 26, 2018
Last Update Posted:
Jun 26, 2018
Last Verified:
Jun 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hee-Pyoung Park, professor, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2018