Failed or Difficult IntubationNCT06058221
Hybrid Intubation Technique for Difficult Airway Children
A study testing simultaneous videolaryngoscopy and supraglottic airway in people with Failed or Difficult Intubation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To compare two hybrid techniques, flexible bronchoscopy-guided intubation with a video laryngoscope and flexible bronchoscopy-guided intubation with a laryngeal mask, that have recently shown promise as a way to increase first-attempt success rates and reduce complications in children with anticipated difficult… Read more about this study
- Who is it for?
- Ages 1 month to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Failed or Difficult Intubation
- What is being tested?
- simultaneous videolaryngoscopy and supraglottic airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Oct 2023to 31 Jul 2025
- Phase
- Interventional
- 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 1 month to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from 1 month of age to less than 12 years of age who are expected to have a difficult intubation when undergoing routine surgery under general anesthesia.
Who cannot join
- When there is limited mouth opening, making it difficult to insert supraglottic airway ② The patient or their parents do not agree to participate in the study. ③ Other cases deemed unsuitable by the researcher
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university hospital
Seoul, 03080
Eun-hee Kim, 820220723664 ext. 82, beloveun@snu.ac.kr
About this study
Official title: Fiberoptic Intubation With Simultaneous Video-laryngoscopy Versus Through a Supraglottic Airway in Children With a Difficult Airway: a Randomized Controlled Trial
To compare two hybrid techniques, flexible bronchoscopy-guided intubation with a video laryngoscope and flexible bronchoscopy-guided intubation with a laryngeal mask, that have recently shown promise as a way to increase first-attempt success rates and reduce complications in children with anticipated difficult intubation.
- Conditions
- Failed or Difficult Intubation
- Being tested
- simultaneous videolaryngoscopy, supraglottic airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous videolaryngoscopyDevice
Two specialists perform tracheal intubation, one using a video laryngoscope to expose the vocal cords and the other using a fiberoptic bronchoscope.
supraglottic airwayDevice
After inserting the supraglottic airway, the specialist performs intubation using a fiberoptic bronchoscope through the supraglottic airway.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid technique | Experimental | Not described Receives: Device: simultaneous videolaryngoscopy |
| Supraglottic airway | Active comparator | Not described Receives: Device: supraglottic airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
first attempt intubation success rate
The success rate of a healthcare provider's first attempt to insert a tube into a patient's airway. Intubation is defined as successful if the tube is inserted and capnography is first seen. If the fiberoptic bronchoscope comes out of the mouth, it is a failure.
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary outcomes (8)
total intubation time (seconds)
Time from when the performer ends mask ventilation to when capnography first appears.
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Number of intubation attempts
Total number of attempts to intubate, regardless of the method used (failures include bronchoscopy out of the mouth, videolaryngoscope or supraglottic airway out of the mouth, or retrying manual ventilation, even if the method is the same).
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
successful tracheal intubation with the allocated method
Whether successful in intubation according to the allocated method or not
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
successful tracheal intubation (Yes or No)
To define and confirm that "successful intubation" occurs when the endotracheal tube is successfully placed inside the trachea, capnography is visible, and surgery can proceed as a result of successful endotracheal intubation.
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Nadir oxygen saturation during intubation (SpO2 value, %)
the minimum oxygen saturation reported during intubation periods
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Oxygen reserve index during intubation (ORi™, Rainbow Signal Extraction Technology)
the trends of oxygen reserve index during intubation period per 5 seconds
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
intubation-related complication
Complications associated with intubation (airway injury, esophageal intubation, laryngospasm, bronchospasm, intraoral bleeding, arrhythmia, cardiac arrest).
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
The degree of vocal cord exposure assessed with a flexible bronchoscope. (Modified Cormack-Lehane grade, I/II/III/IV)
Degree of vocal cord exposure, as determined by the Modified Cormack-Lehane grade, when a flexible bronchoscope is inserted by the anesthesiologist.
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start6 Oct 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed or Difficult IntubationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058221
- Sponsor's protocol ID
- H-2308-024-1457
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 16 Oct 2023
- 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 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiberoptic Intubation With Simultaneous Video-laryngoscopy Versus Through a Supraglottic Airway in Children With a Difficult Airway: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06058221
- Acronym / sponsor ID
- H-2308-024-1457
- Conditions
- Failed or Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 28 Sep 2023 (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.
To compare two hybrid techniques, flexible bronchoscopy-guided intubation with a video laryngoscope and flexible bronchoscopy-guided intubation with a laryngeal mask, that have recently shown promise as a way to increase first-attempt success rates and reduce complications in children with anticipated difficult intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid technique | Experimental | Device: simultaneous videolaryngoscopy |
| Supraglottic airway | Active comparator | Device: supraglottic airway |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children from 1 month of age to less than 12 years of age who are expected to have a difficult intubation when undergoing routine surgery under general anesthesia.
Key exclusion criteria (1 listed)
- When there is limited mouth opening, making it difficult to insert supraglottic airway ② The patient or their parents do not agree to participate in the study. ③ Other cases deemed unsuitable by the researcher
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 |
|---|---|---|
| simultaneous videolaryngoscopyTwo specialists perform tracheal intubation, one using a video laryngoscope to expose the vocal cords and the other using a fiberoptic bronchoscope. | Device | Hybrid technique |
| supraglottic airwayAfter inserting the supraglottic airway, the specialist performs intubation using a fiberoptic bronchoscope through the supraglottic airway. | Device | Supraglottic airway |
Primary outcome
first attempt intubation success rate
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
The success rate of a healthcare provider's first attempt to insert a tube into a patient's airway. Intubation is defined as successful if the tube is inserted and capnography is first seen. If the fiberoptic bronchoscope comes out of the mouth, it is a failure.
8 secondary outcomes
total intubation time (seconds)
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Number of intubation attempts
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
successful tracheal intubation with the allocated method
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
successful tracheal intubation (Yes or No)
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Nadir oxygen saturation during intubation (SpO2 value, %)
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Oxygen reserve index during intubation (ORi™, Rainbow Signal Extraction Technology)
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
intubation-related complication
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
The degree of vocal cord exposure assessed with a flexible bronchoscope. (Modified Cormack-Lehane grade, I/II/III/IV)
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simultaneous videolaryngoscopy and supraglottic airway in people with Failed or Difficult Intubation, 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 1 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 16 Oct 2023. 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-Bin Park, MD (0220723664 ext. 82, jb4001@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first attempt intubation success rate (time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.). 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 16 Oct 2023.