Clinical trial NCT02769221: Intubation Success Rate_Rigid Video Stylet Vs Video Laryngoscope
Official title: Comparison of the Initial Intubation Success Rate Between Video Laryngoscope and Rigid Video Stylet in Patients Undergoing Cervical Spine Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation, Intratracheal
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 370
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compare the intubation success rate between video laryngoscope and rigid video stylet in cervical spine surgery patients. Half of patients will receive endotracheal intubation by video laryngscope, other half of patients will receive endotracheal intubation by rigid video laryngoscope.

Detailed description: Video laryngoscope and lightwand are widely used at endotracheal intubation in cervical spine patients.

Video laryngoscope is useful because of identification of anatomic structure around the oral cavity and vocal cord.

Rigid video stylet resemble lightwand, but it has a video at the end of stylet. So rigid video stylet is useful at confirmation of vocal cord.

Eligibility criteria: Inclusion Criteria:

* 20\~80 years old adult patients, ASA class I-III
* Cervical spine surgery in general anesthesia

Exclusion Criteria:

* Patients who did not agree with the study
* History of GERD
* Congenital or acquired lesion like tumor, polyp, trauma, abcess, inflammation, foreign body
* Surgery of trachea or airway
* History of radiation around neck area
* Increased possibility of aspiration
* Coagulation abnormality

Primary outcomes:
measure: Comparison of success rate between two groups
timeFrame: immediately
Secondary outcomes:
measure: Survey of blood tinged endotracheal tube, bleeding in oral cavity, hoarseness, sore throat
timeFrame: Within 24 hours after endotracheal intubation
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Pyoung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu CN, Ma WH, Wei JQ, Wei HF, Cen QY, Cai QX, Cao Y. Laryngoscope and a new tracheal tube assist lightwand intubation in difficult airways due to unstable cervical spine. PLoS One. 2015 Mar 24;10(3):e0120231. doi: 10.1371/journal.pone.0120231. eCollection 2015.
citation: Aziz MF, Abrons RO, Cattano D, Bayman EO, Swanson DE, Hagberg CA, Todd MM, Brambrink AM. First-Attempt Intubation Success of Video Laryngoscopy in Patients with Anticipated Difficult Direct Laryngoscopy: A Multicenter Randomized Controlled Trial Comparing the C-MAC D-Blade Versus the GlideScope in a Mixed Provider and Diverse Patient Population. Anesth Analg. 2016 Mar;122(3):740-750. doi: 10.1213/ANE.0000000000001084.
citation: Silverberg MJ, Li N, Acquah SO, Kory PD. Comparison of video laryngoscopy versus direct laryngoscopy during urgent endotracheal intubation: a randomized controlled trial. Crit Care Med. 2015 Mar;43(3):636-41. doi: 10.1097/CCM.0000000000000751.
citation: Dong Y, Li G, Wu W, Su R, Shao Y. Lightwand-guided nasotracheal intubation in oromaxillofacial surgery patients with anticipated difficult airways: a comparison with blind nasal intubation. Int J Oral Maxillofac Surg. 2013 Sep;42(9):1049-53. doi: 10.1016/j.ijom.2013.01.027. Epub 2013 May 25.
citation: Kasuya Y, Takahashi E, Nagai M, Ozaki M. [Comparison of Tracheal Intubation Performance between Macintosh Direct Laryngoscope and McGRATH(R) MAC Video Laryngoscope among Anesthesia Trainees]. Masui. 2015 Dec;64(12):1291-6. Japanese.
citation: Choi JW, Kim JA, Jung HJ, Kim WH. Tracheal Intubation with a McGrath(R) Series 5 Video Laryngoscope by Novice Personnel in a Cervical-immobilized Manikin. J Emerg Med. 2016 Jan;50(1):61-6. doi: 10.1016/j.jemermed.2015.06.079. Epub 2015 Oct 1.
citation: Ong J, Lee CL, Lai HY, Lee Y, Chen TY, Shyr MH. A new video intubating device: trachway intubating stylet. Anaesthesia. 2009 Oct;64(10):1145. doi: 10.1111/j.1365-2044.2009.06092.x. No abstract available.
citation: Yang M, Kim JA, Ahn HJ, Choi JW, Kim DK, Cho EA. Double-lumen tube tracheal intubation using a rigid video-stylet: a randomized controlled comparison with the Macintosh laryngoscope. Br J Anaesth. 2013 Dec;111(6):990-5. doi: 10.1093/bja/aet281. Epub 2013 Aug 23.
citation: Kim JK, Kim JA, Kim CS, Ahn HJ, Yang MK, Choi SJ. Comparison of tracheal intubation with the Airway Scope or Clarus Video System in patients with cervical collars. Anaesthesia. 2011 Aug;66(8):694-8. doi: 10.1111/j.1365-2044.2011.06762.x. Epub 2011 May 13.
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):910-915. doi: 10.1213/01.ane.0000166975.38649.27.