Intubation Success Rate_Rigid Video Stylet Vs Video Laryngoscope

NCT02769221 | Unknown DMC

• 1 other identifier: Rigid video stylet intubation
• Study Type: interventional
• Target: 370
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intubation, Intratracheal

Outcome Measures

Primary Outcomes (1)

• Comparison of success rate between two groups

  immediately

Secondary Outcomes (1)

• Survey of blood tinged endotracheal tube, bleeding in oral cavity, hoarseness, sore throat

  Within 24 hours after endotracheal intubation

Study Arms (2)

Optiscope

EXPERIMENTAL

Endotracheal intubation by rigid video stylet, manufactural named Optiscope.

Device: Rigid video stylet

McGrath

ACTIVE COMPARATOR

Endotracheal intubation by video laryngoscope, manufactural named McGrath.

Device: Video laryngoscope

Interventions

Rigid video stylet DEVICE

Also known as: Optiscope

Optiscope

Video laryngoscope DEVICE

Also known as: McGrath

McGrath

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Related Publications (10)

• 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.

  PMID: 25803435 BACKGROUND

• 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.

  PMID: 26579847 BACKGROUND

• 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.

  PMID: 25479112 BACKGROUND

• 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.

  PMID: 23712007 BACKGROUND

• 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.

  PMID: 26790337 BACKGROUND

• 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.

  PMID: 26432080 BACKGROUND

• 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.

  PMID: 19735417 BACKGROUND

• 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.

  PMID: 23975566 BACKGROUND

• 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.

  PMID: 21564045 BACKGROUND

• 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.

  PMID: 16116013 BACKGROUND

Study Officials

• Hee-Pyoung Park, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee-Pyoung Park, MD, PhD

CONTACT

82-2-2072-2466; hppark@snu.ac.kr

Je Do Son, MD

CONTACT

82-2-2072-2469; handsystem@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 11, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share