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Adequate Bending Angle of a Lightwand

Primary Purpose

Tracheal Intubation

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

bending angle of a lightwand

About this trial

This is an interventional treatment trial for Tracheal Intubation focused on measuring Tracheal Intubation, Lightwand

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

70 degrees

80 degrees

90 degrees

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

sore throat

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

Intubation time

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03693235

First Posted

September 30, 2018

Last Updated

October 1, 2020

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03693235

Brief Title

Adequate Bending Angle of a Lightwand

Official Title

Adequate Bending Angle of a Lightwand for Tracheal Intubation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

November 14, 2018 (Actual)

Primary Completion Date

September 5, 2019 (Actual)

Study Completion Date

September 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Tracheal Intubation

Keywords

Tracheal Intubation, Lightwand

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

70 degrees

Arm Type

Experimental

Arm Description

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

Arm Title

80 degrees

Arm Type

Experimental

Arm Description

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

Arm Title

90 degrees

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

bending angle of a lightwand

Intervention Description

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.

Primary Outcome Measure Information:

Title

sore throat

Description

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

Time Frame

After surgery

Title

Intubation time

Description

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

Time Frame

Intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jung-Man Lee, M.D., PhD.

Organizational Affiliation

SMG-SNU Boramae Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul Metropolitan Government Seoul National University Boramae Medical Center

City

Seoul

ZIP/Postal Code

07061

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

11444456

Citation

Agro F, Hung OR, Cataldo R, Carassiti M, Gherardi S. Lightwand intubation using the Trachlight: a brief review of current knowledge. Can J Anaesth. 2001 Jun;48(6):592-9. doi: 10.1007/BF03016838.

Results Reference

background

PubMed Identifier

22971505

Citation

Chen J, Luo W, Wang E, Lu K. Optimal bent length of lightwand for intubation in adults: a randomized, prospective, comparative study. J Int Med Res. 2012;40(4):1519-31. doi: 10.1177/147323001204000432.

Results Reference

background

PubMed Identifier

10702469

Citation

Davis L, Cook-Sather SD, Schreiner MS. Lighted stylet tracheal intubation: a review. Anesth Analg. 2000 Mar;90(3):745-56. doi: 10.1097/00000539-200003000-00044. No abstract available.

Results Reference

background

PubMed Identifier

26647074

Citation

Kim J, Im KS, Lee JM, Ro J, Yoo KY, Kim JB. Relevance of radiological and clinical measurements in predicting difficult intubation using light wand (Surch-lite) in adult patients. J Int Med Res. 2016 Feb;44(1):136-46. doi: 10.1177/0300060515594193. Epub 2015 Dec 7.

Results Reference

background

PubMed Identifier

8267162

Citation

Szigeti CL, Baeuerle JJ, Mongan PD. Arytenoid dislocation with lighted stylet intubation: case report and retrospective review. Anesth Analg. 1994 Jan;78(1):185-6. doi: 10.1213/00000539-199401000-00034. No abstract available.

Results Reference

background

PubMed Identifier

34000987

Citation

Won D, Lee JM, Lee J, Hwang JY, Kim TK, Chang JE, Kim H, Ma S, Min SW. A pilot study comparing three bend angles for lighted stylet intubation. BMC Anesthesiol. 2021 May 17;21(1):148. doi: 10.1186/s12871-021-01369-8.

Results Reference

derived

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Adequate Bending Angle of a Lightwand

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