General AnesthesiaNCT05277064
Optimal Insertion Depth of FOB for Oral FOB Intubation
An observational study of General Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
For oral fiberoptic intubation, the preliminary insertion depth of the fiberoptic bronchoscope should be important because the excessive insertion depth or too shallow depth might be the reason why the clinicians cannot perform oral fiberoptic intubation completely. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Oral FOB
- Type of treatment
- Pill or oral medicine
- How many people
- 211 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Mar 2022to 31 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients requiring tracheal intubation for general anesthesia without exclusion criteria of our study
Who may be able to join
- patients requiring tracheal intubation for general anesthesia
Who cannot join
- do not agree to participate in the study
- emergency surgery
- predicted difficult intubation
- very weak teeth (especially central teeth)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061
About this study
Official title: Optimal Preliminary Insertion Depth of Fiberoptic Bronchoscope for Visualization of Glottic Opening in Oral Fiberoptic Intubation
For oral fiberoptic intubation, the preliminary insertion depth of the fiberoptic bronchoscope should be important because the excessive insertion depth or too shallow depth might be the reason why the clinicians cannot perform oral fiberoptic intubation completely.
The purpose of the study is to find out the optimal preliminary insertion depth of the fiberoptic bronchoscope for visualization of glottic opening in oral fiberoptic intubation.
Read the detailed description
For oral fiberoptic intubation, the preliminary insertion depth of the fiberoptic bronchoscope should be important because the excessive insertion depth or too shallow depth might be the reason why the clinicians cannot perform oral fiberoptic intubation completely.
The purpose of the study is to find out the optimal preliminary insertion depth of the fiberoptic bronchoscope for visualization of glottic opening in oral fiberoptic intubation.
The investigators will enroll the subjects of the present study after obtaining the written consent.
After enrollment, the investigators will measure some anatomical distance, such as patient height.
After induction of anesthesia and muscle relaxation for tracheal intubation, An investigator who has experiences of numerous fiberoptic intubation will measure the optimal preliminary insertion depth of the fiberoptic bronchoscope from the philtrum, the upper lip, or the incisors for oral fiberoptic intubation, with the aid of assistants. Then, tracheal intubation with a laryngoscope as a routine manner of our institute.
The investigators will calculate the mean value of the optimal depth and find out an formula for that from our data.
- Conditions
- General Anesthesia
- Being tested
- Oral FOB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral FOBOther
After induction of anesthesia and muscle relaxation, An investigator who has experiences of numerous fiberoptic intubations will measure the optimal preliminary insertion depth of the fiberoptic bronchoscope for oral fiberoptic intubation.
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of optimal preliminary insertion depth of FOB (centimeters)
The length of optimal preliminary insertion depth of FOB means the insertion depth of it from the philtrum, the upper lip, or the incisors where the clinicians can see easily the glottic opening while they are flexing the FOB. And that will be recorded as centimeters.
Measured: during tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start7 Mar 2022 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 211 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jung-Man Lee, Seoul National University Hospital
- Investigators
- Jung-Man Lee, MD.PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277064
- Sponsor's protocol ID
- 10-2021-95
- Status last verified
- Mar 2022
- First submitted
- 26 Jan 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If there will be a reasonable request, we will provide the study data after approval of that from the IRB of our institute.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Preliminary Insertion Depth of Fiberoptic Bronchoscope for Visualization of Glottic Opening in Oral Fiberoptic Intubation
- ClinicalTrials.gov ID
- NCT05277064
- Acronym / sponsor ID
- 10-2021-95
- Conditions
- General Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 211 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 7 Mar 2022 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 14 Mar 2022 (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.
For oral fiberoptic intubation, the preliminary insertion depth of the fiberoptic bronchoscope should be important because the excessive insertion depth or too shallow depth might be the reason why the clinicians cannot perform oral fiberoptic intubation completely.
The purpose of the study is to find out the optimal preliminary insertion depth of the fiberoptic bronchoscope for visualization of glottic opening in oral fiberoptic intubation.
Detailed description
For oral fiberoptic intubation, the preliminary insertion depth of the fiberoptic bronchoscope should be important because the excessive insertion depth or too shallow depth might be the reason why the clinicians cannot perform oral fiberoptic intubation completely.
The purpose of the study is to find out the optimal preliminary insertion depth of the fiberoptic bronchoscope for visualization of glottic opening in oral fiberoptic intubation.
The investigators will enroll the subjects of the present study after obtaining the written consent.
After enrollment, the investigators will measure some anatomical distance, such as patient height.
After induction of anesthesia and muscle relaxation for tracheal intubation, An investigator who has experiences of numerous fiberoptic intubation will measure the optimal preliminary insertion depth of the fiberoptic bronchoscope from the philtrum, the upper lip, or the incisors for oral fiberoptic intubation, with the aid of assistants. Then, tracheal intubation with a laryngoscope as a routine manner of our institute.
The investigators will calculate the mean value of the optimal depth and find out an formula for that from our data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients requiring tracheal intubation for general anesthesia without exclusion criteria of our study
Key inclusion criteria (1 listed)
- patients requiring tracheal intubation for general anesthesia
Key exclusion criteria (4 listed)
- do not agree to participate in the study
- emergency surgery
- predicted difficult intubation
- very weak teeth (especially central teeth)
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 |
|---|---|---|
| Oral FOBAfter induction of anesthesia and muscle relaxation, An investigator who has experiences of numerous fiberoptic intubations will measure the optimal preliminary insertion depth of the fiberoptic bronchoscope for oral fiberoptic intubation. | Other | – |
Primary outcome
The length of optimal preliminary insertion depth of FOB (centimeters)
Time frame: during tracheal intubation
The length of optimal preliminary insertion depth of FOB means the insertion depth of it from the philtrum, the upper lip, or the incisors where the clinicians can see easily the glottic opening while they are flexing the FOB. And that will be recorded as centimeters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: Undecided. If there will be a reasonable request, we will provide the study data after approval of that from the IRB of our institute.
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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.
Jung-Man Lee, MD.PhD principal investigator
SMG-SNU Boramae 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 General Anesthesia, run by Seoul National University Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Man Lee, MD.PhD (+82-2-870-2513, jungman007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length of optimal preliminary insertion depth of FOB (centimeters) (time frame: during tracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2022.