Intubation; DifficultNCT01616771
GlideScope®Video Laryngoscope for Difficult Intubation: Implication of the Size of Blade
A study testing Macintosh laryngoscope, GVL selected by weight and smaller sized GVL in people with Intubation; Difficult, run by Seoul National University Hospital.
Trial summary
The investigators evaluated the usefulness of the Glidescope(GVL) compared with direct laryngoscopy in patients whose airway management are anticipated difficult (C\&L grade ≥3) by comparing the laryngoscopic view. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- Macintosh laryngoscope, GVL selected by weight and smaller sized GVL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients whose C\&L grade were over 3 in previous anesthetic records.
Who cannot join
- Patients with pulmonary aspiration, increased intracranial pressure, and severe cardiovascular disease
About this study
The investigators evaluated the usefulness of the Glidescope(GVL) compared with direct laryngoscopy in patients whose airway management are anticipated difficult (C\&L grade ≥3) by comparing the laryngoscopic view. Also, the investigators compared the effectiveness of smaller-size blade of GVL (GVLs) with standard blade of GVL selected by patient's weight (GVLw) in the same patients.
Read the detailed description
We assumed that smaller sized GVL can slide more angulated along the tongue, so the tip of a blade can be placed more anterior and cephalad. The angle of camera would be optimized by inserting the blade further with the blade tip directed toward the larynx. This optimization may be more remarkable with smaller blade because it can be inserted with rotation. Furthermore, the location and the angle of camera are different according to GVL blade size. Considering that patient with difficult airway has hypognathia and more cephalad larynx, it may be helpful with smaller sized GVL (GVLs) rather than GVL selected by weight (GVLw) for improvement of laryngoscopic view in patients with difficult airways. We hypothesized that GVLs can provide better laryngoscopic view than GVLw and DL in patient with difficult airway.
- Conditions
- Intubation; Difficult
- Being tested
- Macintosh laryngoscope, GVL selected by weight, smaller sized GVL
- Keywords
- laryngoscopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopeDevice
Glottis view assessment by direct visualization using Macintosh laryngoscope
GVL selected by weightDevice
Also called GlideScope® videolaryngoscopy selected by weight
Glottis view assessment by GVL selected by weight which is usually selected first
smaller sized GVLDevice
Also called smaller sized GlideScope® videolaryngoscopy
Glottis view assessment by GVL which is smaller in one size than GVL selected by age
| Study group | Role | What they receive |
|---|---|---|
| glottis view assessment | Other | Glottis view assessment using Macintosh laryngoscope \& GVL selected by weight \& smaller sized GVL in single patient Receives: Device: Macintosh laryngoscope; Device: GVL selected by weight; Device: smaller sized GVL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Differences in the Glottis View (C&L Grade) of Macintosh Laryngoscope and GVL Selected by Weight.
Glottis view was scored using C\&L grade by Macintosh laryngoscope and GVL selected by weight, and compared each other.
We used modified C\&L grade: grade 1, all or most of the glottic aperture was visible; grade 2a, posterior cords and cartilage visible; grade 2b, only posterior cartilage visible; grade 3a, epiglottis visible and can be lifted; grade 3b, epiglottis adherent to the posterior pharynx; and grade 4, the epiglottis could not be visualized.
For the statistical analysis, the modified C\&L grade was converted to an ordinal scale; grade 1 to 1, grade 2a to 2, grade 2b to 3, grade 3a to 4, grade 3b to 5, and grade 4 to 6. Therefore, score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view.
Measured: up to 1 day of surgery
Secondary outcomes (1)
The Differences in the Glottis View (C&L Grade) of GVL Selected by Weight and Smaller Sized GVL
Glottis view was scored using C\&L grade by GVL selected by weight and smaller sized GVL, and compared each other.
Score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view.
Measured: up to 1day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intubation; DifficultStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, professor, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616771
- Sponsor's protocol ID
- H-1111-037-385
- Status last verified
- Nov 2014
- First submitted
- 30 Apr 2012
- Last updated
- 4 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlideScope®Video Laryngoscope for Difficult Intubation: Implication of the Size of Blade
- ClinicalTrials.gov ID
- NCT01616771
- Acronym / sponsor ID
- H-1111-037-385
- Conditions
- Intubation; Difficult
- Keywords
- laryngoscopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Posted 3 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators evaluated the usefulness of the Glidescope(GVL) compared with direct laryngoscopy in patients whose airway management are anticipated difficult (C\&L grade ≥3) by comparing the laryngoscopic view. Also, the investigators compared the effectiveness of smaller-size blade of GVL (GVLs) with standard blade of GVL selected by patient's weight (GVLw) in the same patients.
Detailed description
We assumed that smaller sized GVL can slide more angulated along the tongue, so the tip of a blade can be placed more anterior and cephalad. The angle of camera would be optimized by inserting the blade further with the blade tip directed toward the larynx. This optimization may be more remarkable with smaller blade because it can be inserted with rotation. Furthermore, the location and the angle of camera are different according to GVL blade size. Considering that patient with difficult airway has hypognathia and more cephalad larynx, it may be helpful with smaller sized GVL (GVLs) rather than GVL selected by weight (GVLw) for improvement of laryngoscopic view in patients with difficult airways. We hypothesized that GVLs can provide better laryngoscopic view than GVLw and DL in patient with difficult airway.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| glottis view assessment | Other | Device: Macintosh laryngoscope, Device: GVL selected by weight, Device: smaller sized GVLGlottis view assessment using Macintosh laryngoscope \& GVL selected by weight \& smaller sized GVL in single patient |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients whose C\&L grade were over 3 in previous anesthetic records.
Key exclusion criteria (1 listed)
- Patients with pulmonary aspiration, increased intracranial pressure, and severe cardiovascular 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 |
|---|---|---|
| Macintosh laryngoscopeGlottis view assessment by direct visualization using Macintosh laryngoscope | Device | glottis view assessment |
| GVL selected by weightAlso: GlideScope® videolaryngoscopy selected by weightGlottis view assessment by GVL selected by weight which is usually selected first | Device | glottis view assessment |
| smaller sized GVLAlso: smaller sized GlideScope® videolaryngoscopyGlottis view assessment by GVL which is smaller in one size than GVL selected by age | Device | glottis view assessment |
Primary outcome
The Differences in the Glottis View (C&L Grade) of Macintosh Laryngoscope and GVL Selected by Weight.
Time frame: up to 1 day of surgery
Glottis view was scored using C\&L grade by Macintosh laryngoscope and GVL selected by weight, and compared each other. We used modified C\&L grade: grade 1, all or most of the glottic aperture was visible; grade 2a, posterior cords and cartilage visible; grade 2b, only posterior cartilage visible; grade 3a, epiglottis visible and can be lifted; grade 3b, epiglottis adherent to the posterior pharynx; and grade 4, the epiglottis could not be visualized. For the statistical analysis, the modified C\&L grade was converted to an ordinal scale; grade 1 to 1, grade 2a to 2, grade 2b to 3, grade 3a to 4, grade 3b to 5, and grade 4 to 6. Therefore, score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view.
1 secondary outcome
The Differences in the Glottis View (C&L Grade) of GVL Selected by Weight and Smaller Sized GVL
Time frame: up to 1day of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jin-Tae Kim, professor study director
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh laryngoscope, GVL selected by weight and smaller sized GVL in people with Intubation; Difficult, 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 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: finished, as of the sponsor's last update on 4 Nov 2014. 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?
Yes. Results are posted in the registry (first posted 3 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Differences in the Glottis View (C&L Grade) of Macintosh Laryngoscope and GVL Selected by Weight. (time frame: up to 1 day of surgery). 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 4 Nov 2014.