Rigid Video Stylet Vs Conventional Lightwand Intubation (Optiscope)

: Rigid Video Stylet Can Provide More Successful Intubation Than Conventional Lightwand Intubation in Patients With Cervical Spine Operation : A Prospective Randomized Study

Lightwand is a useful alternative device for intubation but scooping movement can induce damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. Optiscope is rigid video stylet which has camera on distal tip of device. In many previous studies, rigid video stylet has proven advantages compared with other intubating devices.

Study Overview

• Status: Unknown
• Conditions: Intubation; Hoarseness; Sorethroat
• Intervention / Treatment: Device: Conventional lightwand intubation; Device: Rigid video stylet

• Study Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hee Pyung Park, MD PhD; Phone Number: 82-2-2072-2466; Email: hppark@snu.ac.kr
• Study Contact Backup: Name: Eugene Kim, MD; Phone Number: 82-2-2072-2469; Email: tomomie@hanmail.net

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-799
    • Recruiting
    • Seoul National University of Hospital
    • Contact: Hee Pyung Park, MD PhD; Phone Number: 82-2-2072-2466; Email: hppark@snu.ac.kr
    • Contact: Eugene Kim, MD; Phone Number: 82-2-2072-2469; Email: tomomie@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for cervical spine surgery under general anesthesia
• aged between 20- 80 yrs

Exclusion Criteria:

• Patient who disagrees to participate this study
• Patient who has history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
• Patient who has congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation or foreign bodies in the upper airway

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lightwand; Conventional lightwand intubation will performe for intubation	Device: Conventional lightwand intubation; Conventional lightwand intubation technique will perform during intubation
Experimental: Optiscope; Rigid video stylet, manufactural named Optiscope, will perform for intubation	Device: Rigid video stylet; Rigid video stylet will inserted through endotracheal tube before induction. After induction with propofol and remifentanil using TIVA infusion pump, rocuronium 0.6mg/kg were used to facilitate intubation. After 2minutes, board-certificated anesthesiologist perform intubation using Optiscope.; Other Names: Optiscope® (Pacific Medical, Seoul, Republic of Korea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary success rate of intubation	compare primary success rate of intubation using Optiscope with lightwand intubation	within 90 sec from insertion of device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time	Check the intubation time (sec) Intubation time defines "from insertion of device to oral cavity of patients to confirm successful intubation"	within 90 seconds from insertion of device
postoperative complications	check the postoperative hoarseness, sorethroat and using numeric rating scale (0-10 point) we checked sorethroat score	During PACU stay time expected up to 1hr
postoperative complications	check the postoperative hoarseness, sorethroat and using numeric rating scale (0-10 point) we checked sorethroat score	24 hr after operation
hemodynamic change	check the changes of mean blood pressure, heart rate, pulse oximetry before and after intubation	baseline and 1minute after intubation
number of intubation trial and scooping movements	Check the number of intubation tiral and scooping movements during intubation	during intubation time, an expected average of 1minute

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Hee Pyung Park, MD PhD, Professor; Principal Investigator: Eugene Kim, MD, Fellow

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: February 21, 2014
• First Submitted That Met QC Criteria: February 25, 2014
• First Posted (Estimate): February 27, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 15, 2015
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Laryngeal Diseases; Voice Disorders; Pharyngitis; Hoarseness
• Other Study ID Numbers: Optiscope_SNUH