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Rigid Video Stylet Vs Conventional Lightwand Intubation (Optiscope)

Primary Purpose

Hoarseness, Intubation, Sorethroat

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Conventional lightwand intubation

Rigid video stylet

About this trial

This is an interventional treatment trial for Hoarseness

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University of HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lightwand

Optiscope

Arm Description

Conventional lightwand intubation will performe for intubation

Rigid video stylet, manufactural named Optiscope, will perform for intubation

Outcomes

Primary Outcome Measures

Primary success rate of intubation

compare primary success rate of intubation using Optiscope with lightwand intubation

Secondary Outcome Measures

Intubation time

Check the intubation time (sec) Intubation time defines "from insertion of device to oral cavity of patients to confirm successful intubation"

postoperative complications

check the postoperative hoarseness, sorethroat and using numeric rating scale (0-10 point) we checked sorethroat score

postoperative complications

check the postoperative hoarseness, sorethroat and using numeric rating scale (0-10 point) we checked sorethroat score

hemodynamic change

check the changes of mean blood pressure, heart rate, pulse oximetry before and after intubation

number of intubation trial and scooping movements

Check the number of intubation tiral and scooping movements during intubation

Full Information

NCT ID

NCT02073786

First Posted

February 21, 2014

Last Updated

February 15, 2015

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02073786

Brief Title

Rigid Video Stylet Vs Conventional Lightwand Intubation

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

March 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hoarseness, Intubation, Sorethroat

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lightwand

Arm Type

Active Comparator

Arm Description

Conventional lightwand intubation will performe for intubation

Arm Title

Optiscope

Arm Type

Experimental

Arm Description

Rigid video stylet, manufactural named Optiscope, will perform for intubation

Intervention Type

Device

Intervention Name(s)

Conventional lightwand intubation

Intervention Description

Conventional lightwand intubation technique will perform during intubation

Intervention Type

Device

Intervention Name(s)

Rigid video stylet

Other Intervention Name(s)

Optiscope® (Pacific Medical, Seoul, Republic of Korea)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Primary success rate of intubation

Description

compare primary success rate of intubation using Optiscope with lightwand intubation

Time Frame

within 90 sec from insertion of device

Secondary Outcome Measure Information:

Title

Intubation time

Description

Check the intubation time (sec) Intubation time defines "from insertion of device to oral cavity of patients to confirm successful intubation"

Time Frame

within 90 seconds from insertion of device

Title

postoperative complications

Description

check the postoperative hoarseness, sorethroat and using numeric rating scale (0-10 point) we checked sorethroat score

Time Frame

During PACU stay time expected up to 1hr

Title

postoperative complications

Description

check the postoperative hoarseness, sorethroat and using numeric rating scale (0-10 point) we checked sorethroat score

Time Frame

24 hr after operation

Title

hemodynamic change

Description

check the changes of mean blood pressure, heart rate, pulse oximetry before and after intubation

Time Frame

baseline and 1minute after intubation

Title

number of intubation trial and scooping movements

Description

Check the number of intubation tiral and scooping movements during intubation

Time Frame

during intubation time, an expected average of 1minute

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hee Pyung Park, MD PhD

Phone

82-2-2072-2466

hppark@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Eugene Kim, MD

Phone

82-2-2072-2469

tomomie@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hee Pyung Park, MD PhD

Organizational Affiliation

Professor

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Eugene Kim, MD

Organizational Affiliation

fellow

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University of Hospital

City

Seoul

ZIP/Postal Code

110-799

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hee Pyung Park, MD PhD

Phone

82-2-2072-2466

hppark@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

Eugene Kim, MD

Phone

82-2-2072-2469

tomomie@hanmail.net

12. IPD Sharing Statement

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Rigid Video Stylet Vs Conventional Lightwand Intubation

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