Rigid Video Stylet Vs Conventional Lightwand Intubation

Intubation Clinical Trial

— Optiscope  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02073786
• Other study ID #: Optiscope_SNUH
• Status: Recruiting
• Phase: N/A
• First received: February 21, 2014
• Last updated: February 15, 2015
• Start date: October 2014

Study information

• Verified date: February 2014
• Source: Seoul National University Hospital
• Contact: Hee Pyung Park, MD PhD
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hoarseness
• Intubation
• Sorethroat

Intervention

Device:
• Conventional lightwand intubation
Conventional lightwand intubation technique will perform during intubation
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University of Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary success rate of intubation	compare primary success rate of intubation using Optiscope with lightwand intubation	within 90 sec from insertion of device	Yes
Secondary	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	No
Secondary	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	No
Secondary	postoperative complications	check the postoperative hoarseness, sorethroat and using numeric rating scale (0-10 point) we checked sorethroat score	24 hr after operation	No
Secondary	hemodynamic change	check the changes of mean blood pressure, heart rate, pulse oximetry before and after intubation	baseline and 1minute after intubation	No
Secondary	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	No