Adequate Bending Angle of a Lightwand

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Jung-Man Lee，Seoul National University Hospital

Tracking Information

First Submitted Date ^ICMJE

September 30, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 4, 2018

Estimated Primary Completion Date

July 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

sore throat[ Time Frame: After surgery ]

After surgery, investigators evaluate VAS score for sore throat of the patients.

Intubation time[ Time Frame: Intraoperative ]

from initiation of tracheal intubation with a lightwand after bending it to completion of tracheal intubation

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Adequate Bending Angle of a Lightwand

Official Title ^ICMJE

Adequate Bending Angle of a Lightwand for Tracheal Intubation

Brief Summary

For tracheal intubation with a lightwand, adequate bending angle was not exactly investigated. The purpose of the study is compare three bending angles of lightwands for safe and efficient tracheal intubation.

Detailed Description

Lightwands are very useful device for difficult airway management due to small moth opening, weak teeth, and cervical spine instability. Experienced clinicians use a lightwand while bending it adequately. However, there has been not previous studies to investigate the adequate angle to bend it. This randomized controlled trial is to compare three angles (70, 80, and 90 degrees) as bending angle of lightwands for safe and efficient tracheal intubation in cases which require the use of lightwands.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: bending angle of a lightwand
For tracheal intubation, investigators will bend the tracheal tube combined a lightwand by assigned angles (70, 80, or 90 degrees) for each patient. Next a practitioner will perform tracheal intubation with the bent tube.

Study Arms

Experimental: 70 degrees
During tracheal intubation using a lightwand, the tracheal tube combined with a lightwand will be bent by 70 degrees.
Experimental: 80 degrees
During tracheal intubation using a lightwand, the tracheal tube combined with a lightwand will be bent by 80 degrees.
Experimental: 90 degrees
During tracheal intubation using a lightwand, the tracheal tube combined with a lightwand will be bent by 90 degrees.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 31, 2019

Estimated Primary Completion Date

July 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - patients who require use of a lightwand for tracheal tubes (i.e. small mouth opening, weak teeth, cervical spine instability) Exclusion Criteria: - patients who refuse to participate the study

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Jung-Man Lee，Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Jung-Man Lee, M.D., PhD. Seoul Metropolitan Government Seoul National University Boramae Medical Center

PRS Account

Seoul National University Hospital

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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