C-MAC Videolaryngoscope Intubation and Cervical Spine Motion

NCT ID: NCT03567902

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-30
• Study Completion Date: 2019-05-31

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.

Conditions

Intubation;Difficult; Cervical Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Group A

C-MAC videolaryngoscope intubation -\> Direct laryngoscope intubation

Group Type: EXPERIMENTAL

C-MAC videolaryngoscope intubation

Intervention Type: DEVICE

C-MAC videolaryngoscope intubation

Direct laryngoscope intubation

Intervention Type: DEVICE

Direct laryngoscope intubation

Group B

Direct laryngoscope intubation -\> C-MAC videolaryngoscope intubation

Group Type: EXPERIMENTAL

C-MAC videolaryngoscope intubation

Intervention Type: DEVICE

C-MAC videolaryngoscope intubation

Direct laryngoscope intubation

Intervention Type: DEVICE

Direct laryngoscope intubation

Interventions

C-MAC videolaryngoscope intubation

C-MAC videolaryngoscope intubation

Intervention Type: DEVICE

Direct laryngoscope intubation

Direct laryngoscope intubation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hee-Pyoung Park

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

82-2- 2072-2469 Park, Park

Role: PRINCIPAL_INVESTIGATOR

Seoul National University of Hospital

Central Contacts

Hee Pyung Park, MD PhD

Role: CONTACT

hppark@snu.ac.kr

82-2-2072-2466

Hyesun Paik, MD

Role: CONTACT

molf0917@gmail.com

82-2- 2072-2469

References

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.

Reference Type: BACKGROUND

PMID: 16116013 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18292443 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28244946 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32799791 (View on PubMed)

Other Identifiers

1804-123-940

Identifier Type: -

Identifier Source: org_study_id