IntubationNCT02952690
Different Stylet Angles for Orotracheal Intubation Using Glidescope® Video Laryngoscope in Children
A study testing Glidescope® with tip manipulated stylet and Glidescope® with standard-curved tip 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 evaluate the feasibility of endotracheal intubation via glidescope videolaryngoscope (GVL) using different curve of stylet in 120 children aged between 1 and 5 year old. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation
- What is being tested?
- Glidescope® with tip manipulated stylet and Glidescope® with standard-curved tip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Apr 2017
- 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 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged between 1 and 5 years who are scheduled for elective surgery
- American Society of Anesthesiologist physical status I, II
Who cannot join
- History of asthma
- Active upper respiratory infection
- Significant cardiopulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparison of Different Stylet Angles for Orotracheal Intubation Using Glidescope® Video Laryngoscope in Children
The purpose of this study is to evaluate the feasibility of endotracheal intubation via glidescope videolaryngoscope (GVL) using different curve of stylet in 120 children aged between 1 and 5 year old.
Read the detailed description
Pediatric patients aged 1-5 year old are randomly assigned to one of two groups; standard curve (S) and tip-manipulated curve (T) groups. After routine anesthetic induction, endotracheal intubation is performed with GVL. Size of GVL blade is selected according to weight; GVL 0: <1.5kg, GVL 1:1.5-3.6kg, GVL 2: 1.8-10kg, GVL 2.5: 10-28kg). Before intubation, stylet curve is differently manipulated according to group. The style is curved in accordance with the curve of GVL blade in S group, whereas the distal tip of style is additionally bended to the left (15-20 degree) in T group.
Time from visualization of glottis with GVL to approaching of endotracheal tube to glottis, and time to completion of intubation are measured. In addition, the easiness of intubation is assessed using Visual Analogue Scale (0: extremely easy, 10: extremely difficult) and will be compared in both groups.
- Conditions
- Intubation
- Being tested
- Glidescope® with tip manipulated stylet, Glidescope® with standard-curved tip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glidescope® with tip manipulated styletDevice
The intubating style is curved in accordance with the curve of GVL blade and the distal tip of style is additionally bended to the left (15-20 degree)
Glidescope® with standard-curved tipDevice
The style is curved in accordance with the curve of GVL blade
| Study group | Role | What they receive |
|---|---|---|
| standard curve group | Active comparator | The style is curved in accordance with the curve of GVL blade in this group. Receives: Device: Glidescope® with standard-curved tip |
| tip-manipulated curve group | Experimental | The style is curved in accordance with the curve of GVL blade and the distal tip of style is additionally bended to the left (15-20 degree) in this group. Receives: Device: Glidescope® with tip manipulated stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tracheal intubation
From the insertion of GVL to completion of endotracheal intubation
Measured: up to 3 min after insertion of GVL
Secondary outcomes (5)
Time to approaching of endotracheal tube tip to glottis
From the insertion of GVL to approaching of endotracheal tube tip to glottis
Measured: up to 3 min after insertion of GVL
Number of attempt for glottis passage of endotracheal tube
Measured: up to 3 min after insertion of GVL
The change in stylet angle
The number of additional manipulation of stylet for success of endotracheal intubation
Measured: up to 3 min after insertion of GVL
Visual analogue scale for the easiness of endotracheal intubation
Measurement of the easiness of endotracheal intubation
Measured: up to 3 min after insertion of GVL
Successful endotracheal intubation in 30 seconds
Success or failure in completion of endotracheal intubation in 30 seconds
Measured: up to 3 min after insertion of GVL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionApr 2017
- Study completionApr 2017
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952690
- Sponsor's protocol ID
- H1608-156-787
- Status last verified
- Feb 2018
- First submitted
- 19 Oct 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Different Stylet Angles for Orotracheal Intubation Using Glidescope® Video Laryngoscope in Children
- ClinicalTrials.gov ID
- NCT02952690
- Acronym / sponsor ID
- H1608-156-787
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 2 Nov 2016 (estimated)
- 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 evaluate the feasibility of endotracheal intubation via glidescope videolaryngoscope (GVL) using different curve of stylet in 120 children aged between 1 and 5 year old.
Detailed description
Pediatric patients aged 1-5 year old are randomly assigned to one of two groups; standard curve (S) and tip-manipulated curve (T) groups. After routine anesthetic induction, endotracheal intubation is performed with GVL. Size of GVL blade is selected according to weight; GVL 0: <1.5kg, GVL 1:1.5-3.6kg, GVL 2: 1.8-10kg, GVL 2.5: 10-28kg). Before intubation, stylet curve is differently manipulated according to group. The style is curved in accordance with the curve of GVL blade in S group, whereas the distal tip of style is additionally bended to the left (15-20 degree) in T group.
Time from visualization of glottis with GVL to approaching of endotracheal tube to glottis, and time to completion of intubation are measured. In addition, the easiness of intubation is assessed using Visual Analogue Scale (0: extremely easy, 10: extremely difficult) and will be compared in both groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard curve group | Active comparator | Device: Glidescope® with standard-curved tipThe style is curved in accordance with the curve of GVL blade in this group. |
| tip-manipulated curve group | Experimental | Device: Glidescope® with tip manipulated styletThe style is curved in accordance with the curve of GVL blade and the distal tip of style is additionally bended to the left (15-20 degree) in this group. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged between 1 and 5 years who are scheduled for elective surgery
- American Society of Anesthesiologist physical status I, II
Key exclusion criteria (3 listed)
- History of asthma
- Active upper respiratory infection
- Significant cardiopulmonary 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 |
|---|---|---|
| Glidescope® with tip manipulated styletThe intubating style is curved in accordance with the curve of GVL blade and the distal tip of style is additionally bended to the left (15-20 degree) | Device | tip-manipulated curve group |
| Glidescope® with standard-curved tipThe style is curved in accordance with the curve of GVL blade | Device | standard curve group |
Primary outcome
Time to tracheal intubation
Time frame: up to 3 min after insertion of GVL
From the insertion of GVL to completion of endotracheal intubation
5 secondary outcomes
Time to approaching of endotracheal tube tip to glottis
Time frame: up to 3 min after insertion of GVL
Number of attempt for glottis passage of endotracheal tube
Time frame: up to 3 min after insertion of GVL
The change in stylet angle
Time frame: up to 3 min after insertion of GVL
Visual analogue scale for the easiness of endotracheal intubation
Time frame: up to 3 min after insertion of GVL
Successful endotracheal intubation in 30 seconds
Time frame: up to 3 min after insertion of GVL
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 19 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Glidescope® with tip manipulated stylet and Glidescope® with standard-curved tip 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 3 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 19 Feb 2018. 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?
Time to tracheal intubation (time frame: up to 3 min after insertion of GVL). 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 19 Feb 2018.