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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02073786
Other study ID # Optiscope_SNUH
Secondary ID
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. completion date
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


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
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