Airway ManagementNCT07704723
First Attempt Success in Tracheal Intubation Through Supraglottic Airway Devices Without Fiberoptic Guidance
A study testing Video-assisted supraglottic airway device and Conventional intubating supraglottic airway device in people with Airway Management, run by Seoul National University Hospital.
Trial summary
This randomized controlled trial aims to compare the first-attempt success rate of tracheal intubation through supraglottic airway devices using a conventional intubating supraglottic airway device versus a video-assisted supraglottic airway device without fiberoptic guidance in adult patients undergoing elective… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Airway Management
- What is being tested?
- Video-assisted supraglottic airway device and Conventional intubating supraglottic airway device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Aug 2029
- 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 elective surgery under general anesthesia requiring tracheal intubation.
Who cannot join
- Refusal or inability to provide informed consent.
- Emergency surgery.
- History of gastroesophageal reflux disease.
- Previous surgery or radiotherapy involving the upper airway.
- Severely loose teeth.
- Any condition considered by the investigator to make study participation inappropriate.
About this study
Official title: First Attempt Success in Tracheal Intubation Through Supraglottic Airway Devices Without Fiberoptic Guidance: Conventional vs. Video-assisted Supraglottic Airway Devices, a Randomized Controlled Trial
This randomized controlled trial aims to compare the first-attempt success rate of tracheal intubation through supraglottic airway devices using a conventional intubating supraglottic airway device versus a video-assisted supraglottic airway device without fiberoptic guidance in adult patients undergoing elective surgery under general anesthesia. A total of 204 participants will be randomly assigned to one of the two groups. The primary outcome is the first-attempt success rate of tracheal intubation through the supraglottic airway device. Secondary outcomes include intubation time, number of intubation attempts, overall intubation success, hemodynamic changes, airway-related complications, postoperative sore throat and hoarseness, and adverse events. The results of this study may help identify a safe and effective airway management strategy when fiberoptic bronchoscopy is unavailable.
- Conditions
- Airway Management
- Being tested
- Video-assisted supraglottic airway device, Conventional intubating supraglottic airway device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-assisted supraglottic airway deviceDevice
Also called SaCo VLM
A video-assisted supraglottic airway device is inserted after induction of general anesthesia, and tracheal intubation is performed through the device without fiberoptic guidance.
Conventional intubating supraglottic airway deviceDevice
Also called AirQ
A conventional intubating supraglottic airway device is inserted after induction of general anesthesia, and tracheal intubation is performed through the device without fiberoptic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Video-assisted Supraglottic Airway Device | Experimental | Participants undergo tracheal intubation through a video-assisted supraglottic airway device without fiberoptic guidance during general anesthesia. Receives: Device: Video-assisted supraglottic airway device |
| Conventional Supraglottic Airway Device | Active comparator | Participants undergo tracheal intubation through a conventional intubating supraglottic airway device without fiberoptic guidance during general anesthesia. Receives: Device: Conventional intubating supraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-attempt success rate of tracheal intubation through the supraglottic airway device
The proportion of participants in whom tracheal intubation through the assigned supraglottic airway device is successfully achieved on the first attempt without fiberoptic guidance.
Measured: At the time of tracheal intubation during induction of general anesthesia
Secondary outcomes (5)
Intubation time
Time required for tracheal intubation through the assigned supraglottic airway device.
Measured: During induction of general anesthesia
Number of intubation attempts
Number of attempts required to achieve successful tracheal intubation through the assigned supraglottic airway device.
Measured: During induction of general anesthesia
Overall intubation success rate
Proportion of participants with successful tracheal intubation through the assigned supraglottic airway device regardless of the number of attempts.
Measured: During induction of general anesthesia
Postoperative sore throat
Incidence and severity of postoperative sore throat.
Measured: 1 hour and 24 hours after surgery
Postoperative hoarseness
Incidence of postoperative hoarseness.
Measured: 1 hour and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shin Kyung Won, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704723
- Sponsor's protocol ID
- 2605-119-1747
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Attempt Success in Tracheal Intubation Through Supraglottic Airway Devices Without Fiberoptic Guidance: Conventional vs. Video-assisted Supraglottic Airway Devices, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07704723
- Acronym / sponsor ID
- 2605-119-1747
- Conditions
- Airway Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 15 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.
This randomized controlled trial aims to compare the first-attempt success rate of tracheal intubation through supraglottic airway devices using a conventional intubating supraglottic airway device versus a video-assisted supraglottic airway device without fiberoptic guidance in adult patients undergoing elective surgery under general anesthesia. A total of 204 participants will be randomly assigned to one of the two groups. The primary outcome is the first-attempt success rate of tracheal intubation through the supraglottic airway device. Secondary outcomes include intubation time, number of intubation attempts, overall intubation success, hemodynamic changes, airway-related complications, postoperative sore throat and hoarseness, and adverse events. The results of this study may help identify a safe and effective airway management strategy when fiberoptic bronchoscopy is unavailable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-assisted Supraglottic Airway Device | Experimental | Device: Video-assisted supraglottic airway deviceParticipants undergo tracheal intubation through a video-assisted supraglottic airway device without fiberoptic guidance during general anesthesia. |
| Conventional Supraglottic Airway Device | Active comparator | Device: Conventional intubating supraglottic airway deviceParticipants undergo tracheal intubation through a conventional intubating supraglottic airway device without fiberoptic guidance during general anesthesia. |
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 elective surgery under general anesthesia requiring tracheal intubation.
Key exclusion criteria (6 listed)
- Refusal or inability to provide informed consent.
- Emergency surgery.
- History of gastroesophageal reflux disease.
- Previous surgery or radiotherapy involving the upper airway.
- 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 |
|---|---|---|
| Video-assisted supraglottic airway deviceAlso: SaCo VLMA video-assisted supraglottic airway device is inserted after induction of general anesthesia, and tracheal intubation is performed through the device without fiberoptic guidance. | Device | Video-assisted Supraglottic Airway Device |
| Conventional intubating supraglottic airway deviceAlso: AirQA conventional intubating supraglottic airway device is inserted after induction of general anesthesia, and tracheal intubation is performed through the device without fiberoptic guidance. | Device | Conventional Supraglottic Airway Device |
Primary outcome
First-attempt success rate of tracheal intubation through the supraglottic airway device
Time frame: At the time of tracheal intubation during induction of general anesthesia
The proportion of participants in whom tracheal intubation through the assigned supraglottic airway device is successfully achieved on the first attempt without fiberoptic guidance.
5 secondary outcomes
Intubation time
Time frame: During induction of general anesthesia
Number of intubation attempts
Time frame: During induction of general anesthesia
Overall intubation success rate
Time frame: During induction of general anesthesia
Postoperative sore throat
Time frame: 1 hour and 24 hours after surgery
Postoperative hoarseness
Time frame: 1 hour and 24 hours after surgery
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 15 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Video-assisted supraglottic airway device and Conventional intubating supraglottic airway device in people with Airway Management, 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 6 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 15 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?
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 tracheal intubation through the supraglottic airway device (time frame: At the time of tracheal intubation during induction of general 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 15 Jul 2026.