Endotracheal Intubation Using Videolaryngoscope for General AnesthesiaNCT03215823
Predictive Factors of the Difficult Intubation When Using the Videolaryngoscope
An observational study of Endotracheal Intubation Using Videolaryngoscope for General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
The usefulness of videolaryngoscope has been verified by several studies, and the frequency of videolaryngoscopy is increasing in clinical practice. Data on the use of videolaryngoscopes, however, were not sufficiently accumulated when compared with data on the use of previously used macintosh laryngoscopes. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Endotracheal Intubation Using Videolaryngoscope for General Anesthesia
- How many people
- 808 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jul 2017to 14 Nov 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled for endotracheal intubation using videolaryngoscope for general anesthesia
Who may be able to join
- 1. Patients who are scheduled for endotracheal intubation using a videolaryngoscope for general anesthesia
Who cannot join
- Patients who are planned to receive awake intubation
- Patients who have a tracheostomy tube
- Patients who do not cooperate in evaluating the head and neck due to mental retardation
- Trauma patient wearing a neck collar due to cervical fracture
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine
Seoul, 03722
About this study
The usefulness of videolaryngoscope has been verified by several studies, and the frequency of videolaryngoscopy is increasing in clinical practice. Data on the use of videolaryngoscopes, however, were not sufficiently accumulated when compared with data on the use of previously used macintosh laryngoscopes. In addition, videolaryngoscopy increases the success rate of endotracheal intubation compared to conventional macintosh laryngoscopy, but endotracheal intubation with videolaryngoscope is not successful in all cases with one intubation attempt. Therefore, if the difficult endotracheal intubation with the videolaryngoscope can be predicted in advance, it may be possible to improve the success rate of intubation by reducing unnecessary use of the videolaryngoscope and preparing other equipment. There are many studies on the preoperative examination that can predict the difficulty of intubation when using a macintosh laryngoscope. However, there are still attempts to find screening tests that predict precisely the difficult endotracheal intubation because the accuracy of screening tests is not high. In particular, there is a lack of research on factors that can predict difficult endotracheal intubation when using videolaryngoscope. Therefore, the investigators aimed to investigate the factors predictive of difficult endotracheal intubation when attempting intubation using videolaryngoscope.
- Keywords
- Intubation, videolaryngoscope
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 |
|---|---|---|
| 1. Easy endotracheal intubation | Easy endotracheal intubation | |
| 2. Difficult endotracheal intubation | Difficult endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of the difficult endotracheal intubation when using a videolaryngoscope.
logistic regression analysis will be used to find out the predictors of the difficult endotracheal intubation.
Measured: 10 minutes during the induction of general anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start17 Jul 2017
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endotracheal Intubation Using Videolaryngoscope for General AnesthesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 808 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
- NCT03215823
- Sponsor's protocol ID
- 1-2017-0035
- Status last verified
- Feb 2019
- First submitted
- 9 Jul 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stoneham MD. The nasopharyngeal airway. Assessment of position by fibreoptic laryngoscopy. Anaesthesia. 1993 Jul;48(7):575-80. doi: 10.1111/j.1365-2044.1993.tb07119.x.
PubMed 8346770Reed DB, Clinton JE. Proper depth of placement of nasotracheal tubes in adults prior to radiographic confirmation. Acad Emerg Med. 1997 Dec;4(12):1111-4. doi: 10.1111/j.1553-2712.1997.tb03691.x.
PubMed 9408424Han DW, Shim YH, Shin CS, Lee YW, Lee JS, Ahn SW. Estimation of the length of the nares-vocal cord. Anesth Analg. 2005 May;100(5):1533-1535. doi: 10.1213/01.ANE.0000149900.68354.33.
PubMed 15845720Kim HJ, Kim HR, Kim SY, Kim HY, Park WK, Lee MH, Kim HJ. Predictors of difficult intubation when using a videolaryngoscope with an intermediate-angled blade during the first attempt: a prospective observational study. J Clin Monit Comput. 2022 Aug;36(4):1121-1130. doi: 10.1007/s10877-021-00742-9. Epub 2021 Jul 12.
PubMed 34251587
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of the Difficult Intubation When Using the Videolaryngoscope
- ClinicalTrials.gov ID
- NCT03215823
- Acronym / sponsor ID
- 1-2017-0035
- Keywords
- Intubation, videolaryngoscope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 808 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 12 Jul 2017 (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.
The usefulness of videolaryngoscope has been verified by several studies, and the frequency of videolaryngoscopy is increasing in clinical practice. Data on the use of videolaryngoscopes, however, were not sufficiently accumulated when compared with data on the use of previously used macintosh laryngoscopes. In addition, videolaryngoscopy increases the success rate of endotracheal intubation compared to conventional macintosh laryngoscopy, but endotracheal intubation with videolaryngoscope is not successful in all cases with one intubation attempt. Therefore, if the difficult endotracheal intubation with the videolaryngoscope can be predicted in advance, it may be possible to improve the success rate of intubation by reducing unnecessary use of the videolaryngoscope and preparing other equipment. There are many studies on the preoperative examination that can predict the difficulty of intubation when using a macintosh laryngoscope. However, there are still attempts to find screening tests that predict precisely the difficult endotracheal intubation because the accuracy of screening tests is not high. In particular, there is a lack of research on factors that can predict difficult endotracheal intubation when using videolaryngoscope. Therefore, the investigators aimed to investigate the factors predictive of difficult endotracheal intubation when attempting intubation using videolaryngoscope.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Easy endotracheal intubation | – | –Easy endotracheal intubation |
| 2. Difficult endotracheal intubation | – | –Difficult endotracheal intubation |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for endotracheal intubation using videolaryngoscope for general anesthesia
Key inclusion criteria (1 listed)
- 1. Patients who are scheduled for endotracheal intubation using a videolaryngoscope for general anesthesia
Key exclusion criteria (5 listed)
- Patients who are planned to receive awake intubation
- Patients who have a tracheostomy tube
- Patients who do not cooperate in evaluating the head and neck due to mental retardation
- Trauma patient wearing a neck collar due to cervical fracture
- Pregnancy
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
the occurrence of the difficult endotracheal intubation when using a videolaryngoscope.
Time frame: 10 minutes during the induction of general anesthesia.
logistic regression analysis will be used to find out the predictors of the difficult endotracheal 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 12 Feb 2019.
- Results publication: PubMed 8346770Stoneham MD. The nasopharyngeal airway. Assessment of position by fibreoptic laryngoscopy. Anaesthesia. 1993 Jul;48(7):575-80. doi: 10.1111/j.1365-2044.1993.tb07119.x.
- Results publication: PubMed 9408424Reed DB, Clinton JE. Proper depth of placement of nasotracheal tubes in adults prior to radiographic confirmation. Acad Emerg Med. 1997 Dec;4(12):1111-4. doi: 10.1111/j.1553-2712.1997.tb03691.x.
- Results publication: PubMed 15845720Han DW, Shim YH, Shin CS, Lee YW, Lee JS, Ahn SW. Estimation of the length of the nares-vocal cord. Anesth Analg. 2005 May;100(5):1533-1535. doi: 10.1213/01.ANE.0000149900.68354.33.
- Derived from this study: PubMed 34251587Kim HJ, Kim HR, Kim SY, Kim HY, Park WK, Lee MH, Kim HJ. Predictors of difficult intubation when using a videolaryngoscope with an intermediate-angled blade during the first attempt: a prospective observational study. J Clin Monit Comput. 2022 Aug;36(4):1121-1130. doi: 10.1007/s10877-021-00742-9. Epub 2021 Jul 12.
- Individual participant dataSharing planned: No
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 Endotracheal Intubation Using Videolaryngoscope for General Anesthesia, 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 5 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 12 Feb 2019. 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?
the occurrence of the difficult endotracheal intubation when using a videolaryngoscope. (time frame: 10 minutes during the induction of general anesthesia.). 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 NCT03215823, which also lists 4 linked publications.
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 12 Feb 2019.