Intubation Success Rate_Rigid Video Stylet Vs Video Laryngoscope

NCT ID: NCT02769221

Last Updated: 2016-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Intubation, Intratracheal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Optiscope

Endotracheal intubation by rigid video stylet, manufactural named Optiscope.

Group Type EXPERIMENTAL

Rigid video stylet

Intervention Type DEVICE

McGrath

Endotracheal intubation by video laryngoscope, manufactural named McGrath.

Group Type ACTIVE_COMPARATOR

Video laryngoscope

Intervention Type DEVICE

Interventions

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Rigid video stylet

Intervention Type DEVICE

Video laryngoscope

Intervention Type DEVICE

Other Intervention Names

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Optiscope McGrath

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Pyoung Park

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee-Pyoung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Central Contacts

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Hee-Pyoung Park, MD, PhD

Role: CONTACT

82-2-2072-2466

Je Do Son, MD

Role: CONTACT

82-2-2072-2469

References

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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.

Reference Type BACKGROUND
PMID: 25803435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26579847 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25479112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23712007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26790337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26432080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19735417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23975566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21564045 (View on PubMed)

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)

Other Identifiers

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Rigid video stylet intubation

Identifier Type: -

Identifier Source: org_study_id

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