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C-MAC Videolaryngoscope Intubation and Cervical Spine Motion

A Randomized Trial on Comparison of Cervical Spine Motion During Tracheal Intubation Using Direct Laryngoscope Versus C-MAC Videolaryngoscope in Simulated Immobilized Cervical Spine

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03567902
Enrollment
20
Registered
2018-06-26
Start date
2018-06-30
Completion date
2019-05-31
Last updated
2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spinal Cord Injury, Intubation;Difficult

Keywords

C-MAC

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.

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.

Interventions

DEVICEC-MAC videolaryngoscope intubation

C-MAC videolaryngoscope intubation

DEVICEDirect laryngoscope intubation

Direct laryngoscope intubation

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Maximum cervical spine motion (degree)During tracheal intubation time, an expected average of 90 secondsMaximum angles measured at the occiput-C1, C1-C2, C2-C5 segments

Secondary

MeasureTime frameDescription
Intubation timeWithin 90 seconds from insertion of deviceCheck the intubation time (seconds) defines 'from insertion of device to oral cavity of patients to confirm successful intubation'
Number of intubation trialDuring tracheal intubation time, an expected average of 1 minutesCheck the number of intubation trial
Postoperative complicationsDuring PACU stay time expected up to 1 hrCheck the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score

Contacts

Primary ContactHee Pyung Park, MD PhD
hppark@snu.ac.kr82-2-2072-2466
Backup ContactHyesun Paik, MD
molf0917@gmail.com82-2- 2072-2469

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026