Orotracheal IntubationNCT01908218
The Reliability and Validity of the Upper Lip Bite Test to Predict Difficult Laryngoscopy in Korean
An observational study of Orotracheal Intubation, run by Yonsei University at 1 site in South Korea.
Trial summary
Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper management. Several methods to evaluate the anatomical structures has been used during preoperative period for airway assessment. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Orotracheal Intubation
- How many people
- 344 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2009to Feb 2009
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients undergoing general anesthesia with orotracheal intubation
Who may be able to join
- adult patients undergoing general anesthesia with orotracheal intubation
Who cannot join
- patient who have facial anomaly , 2. patients who required a rapid sequence induction
Trial locations and contacts
1 site in 1 country.
About this study
Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper management.
Several methods to evaluate the anatomical structures has been used during preoperative period for airway assessment.
Evaluation methods are such as the Mallampati classification, mouth opening, thyromental distance and sternocostal distance.
the Upper Lip Bite test, evaluates the possibility of a patient cover the mucosa of the upper lip by the lower incisor.
The aim of this study was to assess the clinical usefulness of the Upper Lip Bite test(ULBT) in Korean compared to Modified Mallampati classification(MMT).
- Conditions
- Orotracheal Intubation
- Keywords
- ULBT, diffficult laryngoscopy, Predictive Value of Tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ULBT group | 344 adult patients undergoing general anesthesia with orotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack and Lehane grade
When the patients undergoing general anesthesia with orotracheal intubation, after obtained glottis view with direct laryngoscopy, the performer assessed Cormack and Lehane grade. (It takes about 1 minutes). A grade 1 and 2 were rated as an easy laryngoscopy. Difficult laryngoscopy was defined as the inability to visualize the vocal cords, each includes Grades 3 and 4.
Measured: glottis view with direct laryngoscopy for 1 minute during anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startFeb 2009
- Primary completionFeb 2009
- Study completionFeb 2009
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 Orotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908218
- Sponsor's protocol ID
- 4-2008-0583
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim JC, Ki Y, Kim J, Ahn SW. Ethnic considerations in the upper lip bite test: the reliability and validity of the upper lip bite test in predicting difficult laryngoscopy in Koreans. BMC Anesthesiol. 2019 Jan 10;19(1):9. doi: 10.1186/s12871-018-0675-5.
PubMed 30630419
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of the Upper Lip Bite Test to Predict Difficult Laryngoscopy in Korean
- ClinicalTrials.gov ID
- NCT01908218
- Acronym / sponsor ID
- 4-2008-0583
- Conditions
- Orotracheal Intubation
- Keywords
- ULBT, diffficult laryngoscopy, Predictive Value of Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 25 Jul 2013 (estimated)
- 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.
Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper management.
Several methods to evaluate the anatomical structures has been used during preoperative period for airway assessment.
Evaluation methods are such as the Mallampati classification, mouth opening, thyromental distance and sternocostal distance.
the Upper Lip Bite test, evaluates the possibility of a patient cover the mucosa of the upper lip by the lower incisor.
The aim of this study was to assess the clinical usefulness of the Upper Lip Bite test(ULBT) in Korean compared to Modified Mallampati classification(MMT).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ULBT group | – | –344 adult patients undergoing general anesthesia with orotracheal intubation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients undergoing general anesthesia with orotracheal intubation
Key inclusion criteria (1 listed)
- adult patients undergoing general anesthesia with orotracheal intubation
Key exclusion criteria (1 listed)
- patient who have facial anomaly , 2. patients who required a rapid sequence induction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cormack and Lehane grade
Time frame: glottis view with direct laryngoscopy for 1 minute during anesthesia induction
When the patients undergoing general anesthesia with orotracheal intubation, after obtained glottis view with direct laryngoscopy, the performer assessed Cormack and Lehane grade. (It takes about 1 minutes). A grade 1 and 2 were rated as an easy laryngoscopy. Difficult laryngoscopy was defined as the inability to visualize the vocal cords, each includes Grades 3 and 4.
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 25 Jul 2013.
- Derived from this study: PubMed 30630419Kim JC, Ki Y, Kim J, Ahn SW. Ethnic considerations in the upper lip bite test: the reliability and validity of the upper lip bite test in predicting difficult laryngoscopy in Koreans. BMC Anesthesiol. 2019 Jan 10;19(1):9. doi: 10.1186/s12871-018-0675-5.
Related trials for Orotracheal Intubation
Recruiting
Pilot Study on the Use of Video Laryngoscopy in Pre-hospital Settings
Emergency, Orotracheal Intubation
Not yet recruiting
AI-Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients
Orotracheal Intubation
Not yet recruitingObservational study
Risk of Pneumonia in Intubated Patients in Emergency Situations
Pneumonia, Orotracheal Intubation
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Orotracheal Intubation, run by Yonsei University 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 1 inclusion and 1 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 25 Jul 2013. 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?
Cormack and Lehane grade (time frame: glottis view with direct laryngoscopy for 1 minute during anesthesia induction). 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 NCT01908218, 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 25 Jul 2013; AzTrials last refreshed its copy on 29 Oct 2026.