Comparison of Conventional Lightwand Intubation Versus Video-laryngoscope Guided Lightwand Intubation in Simulated Cervical Spine-immobilized Patients

Among advanced intubation equipment for difficult intubation, a lighted stylet (lightwand) is a widely used equipment in cervical immobilized patients. However, a lightwand, which is used blind, is difficult to make midline positioning and can increase airway complications and hemodynamic changes. In contrast, videolaryngoscope can view vocal cord indirectly through camera, however, it requires cervical movement. Therefore, investigator hypothesized that the combined use of video-laryngoscope and lightwand for intubation can improve the efficacy of intubation compared to the use of lightwand alone in cervical immobilized patients.

Study Overview

• Status: Completed
• Conditions: General Anesthesia
• Intervention / Treatment: Device: Video-laryngoscope guided lightwand; Device: lightwand alone

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged between 20- 80 yrs
2. Patients scheduled surgery under the general anesthesia

Exclusion Criteria:

1. Patient who has history of gastro-esophageal reflux disease, previous airway surgery, anatomical abnormality in the upper airway, or coagulopathy
2. Patients with body mass index >35kg/m2, hemodynamic instability or loosening teeth
3. Patient who disagrees to participate this study or lacks decision-making ability, illiteracy, or foreigner
4. American Society of Anesthesiologists physical status ≥ 3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: video-laryngoscope guided lightwand	Device: Video-laryngoscope guided lightwand; After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. For intubation, video-laryngoscope is inserted into the oral cavity ntil the epiglottis tip was visible without lifting the epiglottic vallecula. Then, the endotracheal tube with lightwand is inserted toward the midline under the epiglottis and the intubation is performed looking the transilluminated light of lightwand.; Other Names: Video laryngoscope (VL310, Zhejiang UE Medical, Zhejiang, China)
Active Comparator: lightwand	Device: lightwand alone; After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. Then, the endotracheal tube with lightwand is inserted and the intubation is performed with conventional method (blind technique by confirming transillumination).; Other Names: LightWand (3960, GE Healthcare, Englewood, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate of intubation	Confirm the success intubation through end-tidal carbon dioxide on a capnography	Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.
The duration of intubation	Define as the duration between insertion of lightwand or video-laryngoscope to oral cavity and removal all intubating devices from oral cavity.	Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of intubation trial and scooping movements	The number of intubation tiral and scooping movements during intubation	during intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Blood pressure change	The difference between maximum mean blood pressure and minimum blood pressure	from start of intubation to 5minute after intubation
Injuries of oral cavity	Check any blood in lips, teeth, endotracheal cuff, and oral cavity	at immediate after intubation and extubation
Postoperative hoarseness	Check "Yes or No" through questioning the patient	at 1hr after PACU arrival and 24hr after operation
Postoperative sore throat	Check using visual analog scale (0-100 points)	at 1hr after PACU arrival and 24hr after operation
Heart rate change	The difference between maximum heart rate and minimum minimum heart rate	from start of intubation to 5minute after intubation

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2016
• Primary Completion (Actual): October 13, 2017
• Study Completion (Actual): October 13, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Intubation; video laryngoscopy; light wand; cervical spine immobilization
• Other Study ID Numbers: 1-2016-0069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No