Intubation ComplicationNCT07682480
Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet
A study testing endotracheal tube in people with Intubation Complication, run by Seoul National University Hospital.
Trial summary
Patients are randomly assigned to either the oral RAE tube group (Group O) or the reinforced tube group (Group R). In both groups, tracheal intubation is performed using a videolaryngoscope without a stylet, and the first-attempt success rate is compared. 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?
- endotracheal tube
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 17 Apr 2028
- 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
- Scheduled to undergo surgery under general anesthesia
Who cannot join
- Refusal to participate in the study
- History of gastroesophageal reflux disease
- Inadequate preoperative fasting
- Congenital or acquired upper airway abnormalities (e.g., tumors, polyps, trauma, abscesses, inflammation, foreign bodies)
- History of upper airway surgery
- High risk of aspiration or bleeding tendency
- Presence of severely loose teeth
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet: Prospective Non-inferiority Comparison
Patients are randomly assigned to either the oral RAE tube group (Group O) or the reinforced tube group (Group R). In both groups, tracheal intubation is performed using a videolaryngoscope without a stylet, and the first-attempt success rate is compared. Upon emergence from anesthesia and removal of the endotracheal tube, the degree of subglottic injury is assessed and compared between the groups. In addition, postoperative sore throat and hoarseness are evaluated and compared at 1 hour and 24 hours after surgery.
- Conditions
- Intubation Complication
- Being tested
- endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal tubeDevice
Tracheal intubation is performed using a videolaryngoscope without a stylet. In Group O, an oral RAE tube is used, while in Group R, a reinforced endotracheal tube is used. Intubation is conducted after induction of general anesthesia. Upon completion of surgery, the endotracheal tube is removed, and the degree of subglottic injury is assessed. Postoperative sore throat and hoarseness are evaluated at 1 hour and 24 hours after extubation.
| Study group | Role | What they receive |
|---|---|---|
| oral RAE tube group | Experimental | Not described Receives: Device: endotracheal tube |
| reinforced tube group | Active comparator | Not described Receives: Device: endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-attempt success rate of tracheal intubation
The proportion of patients in whom tracheal intubation is successfully completed on the first attempt using a videolaryngoscope without a stylet, comparing the oral RAE tube group with the reinforced tube group.
Measured: Immediately after induction of anesthesia
Secondary outcomes (8)
Incidence and grade of subglottic airway injury
Assessed using flexible bronchoscopy at the time of extubation; graded on a 0-3 scale
Measured: Immediately after completion of surgery (at extubation)
Postoperative sore throat score
Sore throat severity assessed using the Numeric Rating Scale (NRS, 0-10) at 1 and 24 hours after surgery.
Measured: 1 hour and 24 hours postoperatively
Incidence of postoperative hoarseness
Binary evaluation (presence or absence) of hoarseness at 1 and 24 hours after surgery.
Measured: 1 hour and 24 hours postoperatively
Cormack-Lehane grade and POGO score
Airway visualisation was assessed during tracheal intubation using the Cormack-Lehane grading system (Grade I-IV, where Grade I indicates full view of the glottis and Grade IV indicates no visible glottic structures; lower grades indicate better glottic visualisation) and the Percentage of Glottic Opening (POGO) score (0-100%, where higher scores indicate better glottic visualisation).
Measured: Periprocedural (during tracheal intubation)
Mean blood pressure
Measured: Periprocedural (immediately before and immediately after tracheal intubation)
Heart rate
Measured: Periprocedural (immediately before and immediately after tracheal intubation)
Oxygen saturation
Measured: Periprocedural (immediately before and immediately after tracheal intubation)
Bispectral index
Measured: Periprocedural (immediately before and immediately after tracheal intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion17 Apr 2027 (estimated)
- Study completion17 Apr 2028 (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
- 246 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
- NCT07682480
- Sponsor's protocol ID
- 2503-040-1621
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 6 Jul 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet: Prospective Non-inferiority Comparison
- ClinicalTrials.gov ID
- NCT07682480
- Acronym / sponsor ID
- 2503-040-1621
- Conditions
- Intubation Complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 17 Apr 2027 (estimated)
- Study completion
- 17 Apr 2028 (estimated)
- First posted
- 6 Jul 2026 (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.
Patients are randomly assigned to either the oral RAE tube group (Group O) or the reinforced tube group (Group R). In both groups, tracheal intubation is performed using a videolaryngoscope without a stylet, and the first-attempt success rate is compared. Upon emergence from anesthesia and removal of the endotracheal tube, the degree of subglottic injury is assessed and compared between the groups. In addition, postoperative sore throat and hoarseness are evaluated and compared at 1 hour and 24 hours after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral RAE tube group | Experimental | Device: endotracheal tube |
| reinforced tube group | Active comparator | Device: endotracheal tube |
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
- Scheduled to undergo surgery under general anesthesia
Key exclusion criteria (7 listed)
- Refusal to participate in the study
- History of gastroesophageal reflux disease
- Inadequate preoperative fasting
- Congenital or acquired upper airway abnormalities (e.g., tumors, polyps, trauma, abscesses, inflammation, foreign bodies)
- History of upper airway surgery
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 |
|---|---|---|
| endotracheal tubeTracheal intubation is performed using a videolaryngoscope without a stylet. In Group O, an oral RAE tube is used, while in Group R, a reinforced endotracheal tube is used. Intubation is conducted after induction of general anesthesia. Upon completion of surgery, the endotracheal tube is removed, and the degree of subglottic injury is assessed. Postoperative sore throat and hoarseness are evaluated at 1 hour and 24 hours after extubation. | Device | oral RAE tube group, reinforced tube group |
Primary outcome
First-attempt success rate of tracheal intubation
Time frame: Immediately after induction of anesthesia
The proportion of patients in whom tracheal intubation is successfully completed on the first attempt using a videolaryngoscope without a stylet, comparing the oral RAE tube group with the reinforced tube group.
8 secondary outcomes
Incidence and grade of subglottic airway injury
Time frame: Immediately after completion of surgery (at extubation)
Postoperative sore throat score
Time frame: 1 hour and 24 hours postoperatively
Incidence of postoperative hoarseness
Time frame: 1 hour and 24 hours postoperatively
Cormack-Lehane grade and POGO score
Time frame: Periprocedural (during tracheal intubation)
Mean blood pressure
Time frame: Periprocedural (immediately before and immediately after tracheal intubation)
Heart rate
Time frame: Periprocedural (immediately before and immediately after tracheal intubation)
Oxygen saturation
Time frame: Periprocedural (immediately before and immediately after tracheal intubation)
Bispectral index
Time frame: Periprocedural (immediately before and immediately after tracheal 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 6 Jul 2026.
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The ED-AWARENESS-2 Trial
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RecruitingObservational study
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.
Questions about this trial
What is this clinical trial studying?
A study testing endotracheal tube in people with Intubation Complication, run by Seoul National University Hospital.
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 7 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: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact KYUNG WON SHIN (02-2072-2469, skwskw126@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-attempt success rate of tracheal intubation (time frame: Immediately after induction of anesthesia). 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 6 Jul 2026.