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

Study Overview
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Brief Summary
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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.

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

Conditions
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General Anesthesia

Intervention / Treatment
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* Device: Video-laryngoscope guided lightwand
* Device: lightwand alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 20- 80 yrs Patients scheduled surgery under the general anesthesia Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: video-laryngoscope guided lightwand<br> | Device: Video-laryngoscope guided lightwand<br>* 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.<br>* Other names: Video laryngoscope (VL310, Zhejiang UE Medical, Zhejiang, China);|
| Active Comparator: lightwand<br> | Device: lightwand alone<br>* 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).<br>* Other names: LightWand (3960, GE Healthcare, Englewood, USA);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, light wand, video laryngoscopy, cervical spine immobilization