C-MAC Videolaryngoscope Intubation and Cervical Spine Motion

Intubation;Difficult Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03567902
• Other study ID #: 1804-123-940
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2018
• Est. completion date: May 2019

Study information

• Verified date: June 2018
• Source: Seoul National University Hospital
• Contact: Hee Pyung Park, MD PhD
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Intubation;Difficult
• Spinal Cord Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

References & Publications (3)

Kim TK, Son JD, Seo H, Lee YS, Bae J, Park HP. A Randomized Crossover Study Comparing Cervical Spine Motion During Intubation Between Two Lightwand Intubation Techniques in Patients With Simulated Cervical Immobilization: Laryngoscope-Assisted Versus Conventional Lightwand Intubation. Anesth Analg. 2017 Aug;125(2):485-490. doi: 10.1213/ANE.0000000000001813. — View Citation

Robitaille A, Williams SR, Tremblay MH, Guilbert F, Thériault M, Drolet P. Cervical spine motion during tracheal intubation with manual in-line stabilization: direct laryngoscopy versus GlideScope videolaryngoscopy. Anesth Analg. 2008 Mar;106(3):935-41, table of contents. doi: 10.1213/ane.0b013e318161769e. — View Citation

Turkstra TP, Craen RA, Pelz DM, Gelb AW. Cervical spine motion: a fluoroscopic comparison during intubation with lighted stylet, GlideScope, and Macintosh laryngoscope. Anesth Analg. 2005 Sep;101(3):910-5, table of contents. Erratum in: Anesth Analg. 2005 Oct;101(4):1011. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum cervical spine motion (degree)	Maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments	During tracheal intubation time, an expected average of 90 seconds
Secondary	Intubation time	Check the intubation time (seconds) defines 'from insertion of device to oral cavity of patients to confirm successful intubation'	Within 90 seconds from insertion of device
Secondary	Number of intubation trial	Check the number of intubation trial	During tracheal intubation time, an expected average of 1 minutes
Secondary	Postoperative complications	Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score	During PACU stay time expected up to 1 hr
Secondary	Postoperative complications	Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score	24 hr after operation
Secondary	Postoperative complications	Blood tinged endotracheal tube ( yes or no)	After extubation, immediate postoperative period