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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Spinal Cord Injury; Intubation;Difficult
• Intervention / Treatment: Device: C-MAC videolaryngoscope intubation; Device: Direct laryngoscope intubation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of intubation trial	Check the number of intubation trial	During tracheal intubation time, an expected average of 1 minutes
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
Postoperative complications	Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score	24 hr after operation
Postoperative complications	Blood tinged endotracheal tube ( yes or no)	After extubation, immediate postoperative period

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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):910-915. doi: 10.1213/01.ane.0000166975.38649.27. Erratum In: Anesth Analg. 2005 Oct;101(4):1011.
• Robitaille A, Williams SR, Tremblay MH, Guilbert F, Theriault 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.
• 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.
• Paik H, Park HP. Randomized crossover trial comparing cervical spine motion during tracheal intubation with a Macintosh laryngoscope versus a C-MAC D-blade videolaryngoscope in a simulated immobilized cervical spine. BMC Anesthesiol. 2020 Aug 15;20(1):201. doi: 10.1186/s12871-020-01118-3.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: June 22, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 22, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: C-MAC
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 1804-123-940

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No