NCT03693235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 14, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2019

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

September 30, 2018

Last Update Submit

October 1, 2020

Conditions

Tracheal Intubation

Keywords

Tracheal IntubationLightwand

Outcome Measures

Primary Outcomes (2)

  • sore throat

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

    After surgery

  • Intubation time

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

    Intraoperative

Study Arms (3)

70 degrees

EXPERIMENTAL

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

Procedure: bending angle of a lightwand

80 degrees

EXPERIMENTAL

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

Procedure: bending angle of a lightwand

90 degrees

EXPERIMENTAL

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

Procedure: bending angle of a lightwand

Interventions

bending angle of a lightwandPROCEDURE

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.

70 degrees80 degrees90 degrees

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who require use of a lightwand for tracheal tubes (i.e. small mouth opening, weak teeth, cervical spine instability)

You may not qualify if:

  • patients who refuse to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Related Publications (6)

  • 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.

    PMID: 11444456BACKGROUND

  • 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.

    PMID: 22971505BACKGROUND

  • 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.

    PMID: 10702469BACKGROUND

  • 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.

    PMID: 26647074BACKGROUND

  • 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.

    PMID: 8267162BACKGROUND

  • 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.

    PMID: 34000987DERIVED

Study Officials

  • Jung-Man Lee, M.D., PhD.

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 30, 2018

First Posted

October 2, 2018

Study Start

November 14, 2018

Primary Completion

September 5, 2019

Study Completion

September 5, 2019

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations

KR(1)