Intubation Success Rate_Rigid Video Stylet Vs Video Laryngoscope

Intubation, Intratracheal Clinical Trial

Official title:

Comparison of the Initial Intubation Success Rate Between Video Laryngoscope and Rigid Video Stylet in Patients Undergoing Cervical Spine Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02769221
• Other study ID #: Rigid video stylet intubation
• Status: Not yet recruiting
• Phase: N/A
• First received: May 10, 2016
• Last updated: May 11, 2016
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: May 2016
• Source: Seoul National University Hospital
• Contact: Hee-Pyoung Park, MD, PhD
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 370
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation, Intratracheal

Intervention

Device:
• Rigid video stylet

• Video laryngoscope

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

References & Publications (10)

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):740-50. doi: 10.1213/ANE.0000000000001084. — View Citation

Choi JW, Kim JA, Jung HJ, Kim WH. Tracheal Intubation with a McGrath® 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. — View 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. — View Citation

Kasuya Y, Takahashi E, Nagai M, Ozaki M. [Comparison of Tracheal Intubation Performance between Macintosh Direct Laryngoscope and McGRATH® MAC Video Laryngoscope among Anesthesia Trainees]. Masui. 2015 Dec;64(12):1291-6. Japanese. — View 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. — View 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. Erratum in: Anaesthesia. 2009 Nov;64(11):1272. — View 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. — 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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of success rate between two groups		immediately	Yes
Secondary	Survey of blood tinged endotracheal tube, bleeding in oral cavity, hoarseness, sore throat		Within 24 hours after endotracheal intubation	Yes