NCT03480035

Brief Summary

If the patients's teeth are weak or the mouth dose not open well, the lightwand is a useful device when endotracheal intubation is necessary. Therefore, if the appropriate position of the light beam is determined and the distance of the light source suitable for intubation using the lightwand is obtained from anatomical structures such as thyroid cartilage and cricoid cartilage, it is clinically useful. Because it can prevent unnecessary deep insertion or shallow insertion that can cause damage to anatomical structures during intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2018

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

March 21, 2018

Last Update Submit

December 20, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • distance from lightbeam of the FOB to thyroid cartilage

    we will measure straight distance from lightbeam of the FOB to thyroid cartilage on the surface of patient's neck

    before intubation

  • distance from lightbeam of the FOB to cricoid cartilage

    we will measure straight distance from lightbeam of the FOB to cricoid cartilage on the surface of patient's neck

    before intubation

Secondary Outcomes (1)

  • distance from lightbeam of the FOB to sternal notch

    before intubation

Interventions

intubation using lightwand

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This is an adult patient who is 18 years of age or older who undergoes general anesthesia requiring intubation. Among them, patients who are unable to extend their necks, have trismus or have weak teeth are selected.

You may qualify if:

  • impossibility of neck extension
  • trismus
  • weak teeth

You may not qualify if:

  • previous history of larynx or neck surgery
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongsan medical center

Daegu, South Korea

Location

Related Publications (1)

  • Cho E, Kim HC, Lee JM, Park JH, Ha N, Hong JH, Lee J. Evaluation of transmitted glow point at a priori chosen depth (1 cm below vocal cords) for lightwand intubation: a prospective observational study. J Int Med Res. 2020 Dec;48(12):300060520974249. doi: 10.1177/0300060520974249.

MeSH Terms

Conditions

TrismusTooth Abnormalities

Condition Hierarchy (Ancestors)

SpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jiwon Lee, Dr.

    Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 21, 2018

First Posted

March 27, 2018

Study Start

March 6, 2018

Primary Completion

July 27, 2018

Study Completion

July 27, 2018

Last Updated

December 21, 2018

Record last verified: 2018-12

Locations