Intubation ComplicationNCT06964295
Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope
A study testing Macintosh videolaryngoscope and Flexible bronchoscope in people with Intubation Complication, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Participants are randomly assigned to two groups: one group undergoes nasotracheal intubation using a videolaryngoscope, while the other group undergoes nasotracheal intubation using a flexible bronchoscope. The primary outcome is the first-attempt success rate, assessed at the time of tracheal tube placement. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Macintosh videolaryngoscope and Flexible bronchoscope
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2025to 7 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adults aged 19 years or older
- Undergoing ear, nose, and throat (ENT) surgery requiring nasotracheal intubation
Who cannot join
- Refusal to participate in the study
- History of gastroesophageal reflux disease
- History of surgery or radiation therapy involving the upper airway
- Presence of severely loose teeth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope: a Randomized Controlled Trial
Participants are randomly assigned to two groups: one group undergoes nasotracheal intubation using a videolaryngoscope, while the other group undergoes nasotracheal intubation using a flexible bronchoscope. The primary outcome is the first-attempt success rate, assessed at the time of tracheal tube placement. Additional outcomes include the degree of subglottic injury upon extubation, and the incidence and severity of sore throat and hoarseness at 1 hour and 24 hours postoperatively, as well as overall intubation success rates.
- Conditions
- Intubation Complication
- Being tested
- Macintosh videolaryngoscope, Flexible bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh videolaryngoscopeDevice
Used to perform nasotracheal intubation under general anesthesia. The Macintosh videolaryngoscope is introduced orally to visualize the glottis, and a preformed nasotracheal tube is inserted through the nostril.
Flexible bronchoscopeDevice
Used to perform nasotracheal intubation under general anesthesia. The bronchoscope is inserted through a lubricated nasotracheal tube and advanced into the trachea.
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope Group | Experimental | Not described Receives: Device: Macintosh videolaryngoscope |
| Flexible Bronchoscope Group | Active comparator | Not described Receives: Device: Flexible bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-attempt success rate of nasotracheal intubation
The proportion of patients in whom nasotracheal intubation is successfully completed on the first attempt, comparing the videolaryngoscope group with the flexible bronchoscope group.
Measured: At the time of tracheal intubation
Secondary outcomes (9)
Degree of subglottic injury
Graded from 0 to 3 using a flexible bronchoscope. Higher scores mean a worse outcome (more severe subglottic injury).
Measured: At the time of extubation
Postoperative sore throat severity
Assessed using the Numeric Rating Scale (0-10) at 1 and 24 hours after surgery.
Measured: 1 hour and 24 hours postoperatively
Incidence of postoperative hoarseness
Presence or absence of hoarseness evaluated at 1 hour and 24 hours postoperatively.
Measured: 1 hour and 24 hours postoperatively
Cormack-Lehane grade
Grading recorded during intubation to evaluate glottic exposure.
Measured: At the time of tracheal intubation
Changes in blood pressure
Changes in blood pressure recorded before and after tracheal intubation.
Measured: Within 5 minutes before and after intubation
POGO score
Visualization scores recorded during intubation to evaluate glottic exposure. The score ranges from 0% (no glottic visualization) to 100% (full view of the glottis). Higher scores indicate a better outcome (better visualization).
Measured: At the time of tracheal intubation
Changes in heart rate
Changes in heart rate recorded before and after tracheal intubation.
Measured: Within 5 minutes before and after intubation
Changes in saturation
Changes in SpO₂ recorded before and after tracheal intubation.
Measured: Within 5 minutes before and after intubation
Changes in bispectral value
Changes in BIS values recorded before and after tracheal intubation.
Measured: Within 5 minutes before and after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start9 May 2025
- Primary completion7 May 2026 (estimated)
- Study completion7 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964295
- Sponsor's protocol ID
- 2503-041-1621
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06964295
- Acronym / sponsor ID
- 2503-041-1621
- Conditions
- Intubation Complication
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- 7 May 2026 (estimated)
- Study completion
- 7 May 2026 (estimated)
- First posted
- 9 May 2025 (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.
Participants are randomly assigned to two groups: one group undergoes nasotracheal intubation using a videolaryngoscope, while the other group undergoes nasotracheal intubation using a flexible bronchoscope. The primary outcome is the first-attempt success rate, assessed at the time of tracheal tube placement. Additional outcomes include the degree of subglottic injury upon extubation, and the incidence and severity of sore throat and hoarseness at 1 hour and 24 hours postoperatively, as well as overall intubation success rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope Group | Experimental | Device: Macintosh videolaryngoscope |
| Flexible Bronchoscope Group | Active comparator | Device: Flexible bronchoscope |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 19 years or older
- Undergoing ear, nose, and throat (ENT) surgery requiring nasotracheal intubation
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- History of gastroesophageal reflux disease
- History of surgery or radiation therapy involving the upper airway
- Presence of severely loose 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 |
|---|---|---|
| Macintosh videolaryngoscopeUsed to perform nasotracheal intubation under general anesthesia. The Macintosh videolaryngoscope is introduced orally to visualize the glottis, and a preformed nasotracheal tube is inserted through the nostril. | Device | Videolaryngoscope Group |
| Flexible bronchoscopeUsed to perform nasotracheal intubation under general anesthesia. The bronchoscope is inserted through a lubricated nasotracheal tube and advanced into the trachea. | Device | Flexible Bronchoscope Group |
Primary outcome
First-attempt success rate of nasotracheal intubation
Time frame: At the time of tracheal intubation
The proportion of patients in whom nasotracheal intubation is successfully completed on the first attempt, comparing the videolaryngoscope group with the flexible bronchoscope group.
9 secondary outcomes
Degree of subglottic injury
Time frame: At the time of extubation
Postoperative sore throat severity
Time frame: 1 hour and 24 hours postoperatively
Incidence of postoperative hoarseness
Time frame: 1 hour and 24 hours postoperatively
Cormack-Lehane grade
Time frame: At the time of tracheal intubation
Changes in blood pressure
Time frame: Within 5 minutes before and after intubation
POGO score
Time frame: At the time of tracheal intubation
Changes in heart rate
Time frame: Within 5 minutes before and after intubation
Changes in saturation
Time frame: Within 5 minutes before and after intubation
Changes in bispectral value
Time frame: Within 5 minutes before and after intubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
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Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
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Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
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?
A study testing Macintosh videolaryngoscope and Flexible bronchoscope in people with Intubation Complication, 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 2 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: enrolling by invitation, as of the sponsor's last update on 28 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
First-attempt success rate of nasotracheal intubation (time frame: At the time of 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 28 Jan 2026.