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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169556
• Other study ID #: 1-2016-0069
• Status: Completed
• Phase: N/A
• First received: May 17, 2017
• Last updated: October 26, 2017
• Start date: December 19, 2016
• Est. completion date: October 13, 2017

Study information

• Verified date: October 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: October 13, 2017
• Est. primary completion date: October 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia

Intervention

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.
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	Blood pressure change	The difference between maximum mean blood pressure and minimum blood pressure	from start of intubation to 5minute after intubation
Secondary	Injuries of oral cavity	Check any blood in lips, teeth, endotracheal cuff, and oral cavity	at immediate after intubation and extubation
Secondary	Postoperative hoarseness	Check "Yes or No" through questioning the patient	at 1hr after PACU arrival and 24hr after operation
Secondary	Postoperative sore throat	Check using visual analog scale (0-100 points)	at 1hr after PACU arrival and 24hr after operation
Secondary	Heart rate change	The difference between maximum heart rate and minimum minimum heart rate	from start of intubation to 5minute after intubation