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

NCT03169556 | Completed DMC

• 1 other identifier: 1-2016-0069
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

General Anesthesia

Keywords

Intubation; light wand; video laryngoscopy; cervical spine immobilization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• number of intubation trial and scooping movements

  during intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time

• Blood pressure change

  from start of intubation to 5minute after intubation

• Injuries of oral cavity

  at immediate after intubation and extubation

• Postoperative hoarseness

  at 1hr after PACU arrival and 24hr after operation

• Postoperative sore throat

  at 1hr after PACU arrival and 24hr after operation

Study Arms (2)

video-laryngoscope guided lightwand

EXPERIMENTAL

Device: Video-laryngoscope guided lightwand

lightwand

ACTIVE COMPARATOR

Device: lightwand alone

Interventions

Video-laryngoscope guided lightwand DEVICE

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.

Also known as: Video laryngoscope (VL310, Zhejiang UE Medical, Zhejiang, China)

video-laryngoscope guided lightwand

lightwand alone DEVICE

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).

Also known as: LightWand (3960, GE Healthcare, Englewood, USA)

lightwand

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 20- 80 yrs
• Patients scheduled surgery under the general anesthesia

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 30, 2017
• Study Start: December 19, 2016
• Primary Completion: October 13, 2017
• Study Completion: October 13, 2017
• Last Updated: October 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)