IntubationNCT04745936
Comparison of Different Stylet Angles for Orotracheal Intubation Using C-MAC® Video Laryngoscopes in Infants
A study testing Style curve similar to natural curvature of endotracheal tube and Style curve similar to hockey stick shape in people with Intubation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate whether the difference in stylet curvature affects the ease of tracheal intubation using C-MAC videolaryngoscope in infants under 1 year of age. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Intubation
- What is being tested?
- Style curve similar to natural curvature of endotracheal tube and Style curve similar to hockey stick shape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Mar 2021to 20 May 2022
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ① Infants under 1 year old scheduled for elective surgery under general anesthesia
- ② American Society of Anesthesiology physical status I, II
Who cannot join
- Any pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate whether the difference in stylet curvature affects the ease of tracheal intubation using C-MAC videolaryngoscope in infants under 1 year of age.
- Conditions
- Intubation
- Being tested
- Style curve similar to natural curvature of endotracheal tube, Style curve similar to hockey stick shape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Style curve similar to natural curvature of endotracheal tubeOther
Stylet curvature is made similar to the natural curvature of endotracheal tube for intubation using C-MAC videolaryngoscope.
Style curve similar to hockey stick shapeOther
Stylet curvature is made similar to hockey stick shape for intubation using C-MAC videolaryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| C-curve group (group C) | Experimental | In group C, stylet curvature is made similar to the natural curvature of endotracheal tube. Receives: Other: Style curve similar to natural curvature of endotracheal tube |
| Hockey stick curve group (group H) | Active comparator | In group H, stylet curvature is made similar to hockey stick shape. Receives: Other: Style curve similar to hockey stick shape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tube handling time
From glottis visualization to completion of tracheal intubation
Measured: during procedure
Secondary outcomes (7)
Total intubation time
From insertion of C-MAC blade to completion of tracheal intubation
Measured: during procedure
Time to reaching glottis
From visualization of glottis to reaching the glottis of tube tip
Measured: during procedure
The location of the initial tube tip
The location of the initial tube tip on the screen of C-MAC
Measured: during procedure
Successful tracheal intubation
Incidence of successful intubation within 30 sec
Measured: during procedure, within 30 sec
Additional manipulation of stylet angle
Measured: during procedure
Number of external laryngeal manipulation
Measured: during procedure
Easiness of tracheal intubation
Visual analogue scale (0-10, 0: extremely easy, 10: extremely difficult)
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start3 Mar 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hyun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745936
- Sponsor's protocol ID
- H2011-196-1178
- Status last verified
- May 2022
- First submitted
- 4 Feb 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Stylet Angles for Orotracheal Intubation Using C-MAC® Video Laryngoscopes in Infants
- ClinicalTrials.gov ID
- NCT04745936
- Acronym / sponsor ID
- H2011-196-1178
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 9 Feb 2021 (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.
The purpose of this study is to investigate whether the difference in stylet curvature affects the ease of tracheal intubation using C-MAC videolaryngoscope in infants under 1 year of age.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-curve group (group C) | Experimental | Other: Style curve similar to natural curvature of endotracheal tubeIn group C, stylet curvature is made similar to the natural curvature of endotracheal tube. |
| Hockey stick curve group (group H) | Active comparator | Other: Style curve similar to hockey stick shapeIn group H, stylet curvature is made similar to hockey stick shape. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ① Infants under 1 year old scheduled for elective surgery under general anesthesia
- ② American Society of Anesthesiology physical status I, II
Key exclusion criteria (1 listed)
- Any pulmonary disease
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 |
|---|---|---|
| Style curve similar to natural curvature of endotracheal tubeStylet curvature is made similar to the natural curvature of endotracheal tube for intubation using C-MAC videolaryngoscope. | Other | C-curve group (group C) |
| Style curve similar to hockey stick shapeStylet curvature is made similar to hockey stick shape for intubation using C-MAC videolaryngoscope. | Other | Hockey stick curve group (group H) |
Primary outcome
Tube handling time
Time frame: during procedure
From glottis visualization to completion of tracheal intubation
7 secondary outcomes
Total intubation time
Time frame: during procedure
Time to reaching glottis
Time frame: during procedure
The location of the initial tube tip
Time frame: during procedure
Successful tracheal intubation
Time frame: during procedure, within 30 sec
Additional manipulation of stylet angle
Time frame: during procedure
Number of external laryngeal manipulation
Time frame: during procedure
Easiness of tracheal intubation
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
Related trials for Intubation
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Active, not recruiting
OR Video-Laryngoscope Evaluations
Video Laryngoscopy, Quality Improvement
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.
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 Style curve similar to natural curvature of endotracheal tube and Style curve similar to hockey stick shape in people with 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 2 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: finished, as of the sponsor's last update on 1 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tube handling time (time frame: during procedure). 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 1 Jun 2022.