Neck DiseaseNCT03480035
Ideal Point of Transluminal Light in Tracheal Intubation With a Light Wand
An observational study of Neck Disease and Trismus, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Disease, Trismus, Tooth Abnormalities
- What is being tested?
- lightwand intubation
- Type of treatment
- Surgery or procedure
- How many people
- 107 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Mar 2018to 27 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- impossibility of neck extension
- trismus
- weak teeth
Who cannot join
- previous history of larynx or neck surgery
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Studies have been reported on the proper position to bend the lightwand and the appropriate angle to bend when performing endotracheal intubation with lightwand. For ease of procedure, the assistant has to lift the patient's lower jaw or perform a neck extension.
However, there is no report on the position of the lightbulb when the light passes through the front of the airway and neck and appears bright in the midpoint.
The prodcedure is as follows.
- FOB examination and check position of light below 1cm from vocal cord
- lightwand intubation aimed at checkpoint
- measurement of distance from thyroid cartilage/cricoid cartilage to light point
- Conditions
- Neck Disease, Trismus, Tooth Abnormalities
- Being tested
- lightwand intubation
- Medical subject headings
- Trismus, Tooth Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lightwand intubationProcedure or surgery
intubation using lightwand
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: before intubation
Secondary outcomes (1)
distance from lightbeam of the FOB to sternal notch
we will measure straight distance from lightbeam of the FOB to sternal notch on the surface of patient's neck
Measured: before intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start6 Mar 2018
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiwon Lee, Keimyung University Dongsan Medical Center
- Investigators
- Jiwon Lee, Dr., Principal investigator, Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480035
- Sponsor's protocol ID
- lightwand intubation
- Status last verified
- Dec 2018
- First submitted
- 21 Mar 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33284717
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ideal Point of Transluminal Light in Tracheal Intubation With a Light Wand
- ClinicalTrials.gov ID
- NCT03480035
- Acronym / sponsor ID
- lightwand intubation
- Conditions
- Neck Disease, Trismus, Tooth Abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Studies have been reported on the proper position to bend the lightwand and the appropriate angle to bend when performing endotracheal intubation with lightwand. For ease of procedure, the assistant has to lift the patient's lower jaw or perform a neck extension.
However, there is no report on the position of the lightbulb when the light passes through the front of the airway and neck and appears bright in the midpoint.
The prodcedure is as follows.
- FOB examination and check position of light below 1cm from vocal cord
- lightwand intubation aimed at checkpoint
- measurement of distance from thyroid cartilage/cricoid cartilage to light point
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- impossibility of neck extension
- trismus
- weak teeth
Key exclusion criteria (2 listed)
- previous history of larynx or neck surgery
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lightwand intubationintubation using lightwand | Procedure or surgery | – |
Primary outcome
distance from lightbeam of the FOB to thyroid cartilage
Time frame: before intubation
we will measure straight distance from lightbeam of the FOB to thyroid cartilage on the surface of patient's neck
distance from lightbeam of the FOB to cricoid cartilage
Time frame: before intubation
we will measure straight distance from lightbeam of the FOB to cricoid cartilage on the surface of patient's neck
1 secondary outcome
distance from lightbeam of the FOB to sternal notch
Time frame: before intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Derived from this study: PubMed 33284717Cho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiwon Lee, Dr. principal investigator
Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Disease and Trismus, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
distance from lightbeam of the FOB to thyroid cartilage (time frame: before intubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.