CholecystitisGlideMStyletNCT02547064
Effect of Modified Stylet Angulation on the Intubation With GlideScope®
A study testing Glidescope guided intubation and GlideScope® in people with Cholecystitis and Stomach Cancer, run by Keimyung University Dongsan Medical Center.
Trial summary
The GlideScope® videolaryngoscope usually visualize glottis better than the conventional laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of endotracheal tube, however, is challenging. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholecystitis, Stomach Cancer
- What is being tested?
- Glidescope guided intubation and GlideScope®
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jan 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring endotracheal intubation for general anesthesia
Who cannot join
- Difficult airway
- Rapid sequence induction
- Recent sore throat
- Fragile teeth
- Contraindication for videolaryngoscope
- Head and neck surgery
About this study
Official title: Stylet Angulation of Seventy Degrees Reduced Time to Intubation With the GlideScope®: A Prospective Randomized Trial
The GlideScope® videolaryngoscope usually visualize glottis better than the conventional laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of endotracheal tube, however, is challenging.
The goal of this study was to determine which of two stylet (70° vs 90°) was better, as determined by time to intubation.
- Conditions
- Cholecystitis, Stomach Cancer
- Being tested
- Glidescope guided intubation, GlideScope®
- Keywords
- intubation, stylet, videolaryngoscope
- Medical subject headings
- Cholecystitis, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glidescope guided intubationProcedure or surgery
GlideScope®Device
| Study group | Role | What they receive |
|---|---|---|
| 90 degree | Active comparator | The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. Receives: Procedure: Glidescope guided intubation; Device: GlideScope® |
| 70 degree | Experimental | The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. Receives: Procedure: Glidescope guided intubation; Device: GlideScope® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubation
Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (>30 mmHg)
Measured: Intraoperative intubation
Secondary outcomes (10)
Success Rate of Intubation
The number of patients in which the intubation was successful at the first time.
Measured: Intraoperative intubation
Difficulty of Intubation Measured Using Visual Analogue Scale
Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult).
Measured: Intraoperative intubation
Number of Participants for Whom External Laryngeal Manipulation Was Necessary
External laryngeal manipulation is defined as the compression of neck for the facilitation of laryngeal view. Number of participants for whom external laryngeal manipulation was necessary will be measured.
Measured: Intraoperative intubation
Cormack-Lehan Grade
The grade of Cormack-Lehan was assessed as I/II/III/IV (I: Full view of glottis, II: Partial view of glottis, III: Only epiglottis seen, none of glottis seen, IV: Neither glottis nor epiglottis seen). Grade I was considered better outcomes.
Measured: Intraoperative intubation
Mallampati Grade
The Mallapati grade was assessed as I/II/III/IV (I: Soft palate, uvula, fauces, pillars visible, II: Soft palate, uvula, fauces visible, III: Soft palate, base of uvula visible, IV: Only hard palate visible). Grade I was considered better outcomes.
Measured: Intraoperative anesthetic induction
Thyromental Distance
The thyromental distance was measured.
Measured: Intraoperative anesthetic induction
Postoperative Sore Throat Measured Using Visual Analogue Scale
Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable)
Measured: at 1, 24 hr postoperatively
Mean Blood Pressure
Mean blood pressure is measured before and 2 min after intubation.
Measured: Intraoperative intubation
Heart Rate
Heart rates are measured before and 2 min after intubation.
Measured: Intraoperative intubation
Airway Injury
Larynx injury is assessed.
Measured: Intraoperative intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2016
- Study completionJan 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Chang Kim, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547064
- Sponsor's protocol ID
- GlideMStylet
- Acronym
- GlideMStylet
- Status last verified
- Jun 2017
- First submitted
- 1 Sep 2015
- Last updated
- 9 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lee YC, Lee J, Son JD, Lee JY, Kim HC. Stylet angulation of 70 degrees reduces the time to intubation with the GlideScope(R): A prospective randomised trial. J Int Med Res. 2018 Apr;46(4):1428-1438. doi: 10.1177/0300060517741065. Epub 2018 Jan 14.
PubMed 29332445
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stylet Angulation of Seventy Degrees Reduced Time to Intubation With the GlideScope®: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02547064
- Acronym / sponsor ID
- GlideMStylet / GlideMStylet
- Conditions
- Cholecystitis, Stomach Cancer
- Keywords
- intubation, stylet, videolaryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Posted 9 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The GlideScope® videolaryngoscope usually visualize glottis better than the conventional laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of endotracheal tube, however, is challenging.
The goal of this study was to determine which of two stylet (70° vs 90°) was better, as determined by time to intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 90 degree | Active comparator | Procedure: Glidescope guided intubation, Device: GlideScope®The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end. |
| 70 degree | Experimental | Procedure: Glidescope guided intubation, Device: GlideScope®The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring endotracheal intubation for general anesthesia
Key exclusion criteria (6 listed)
- Difficult airway
- Rapid sequence induction
- Recent sore throat
- Fragile teeth
- Contraindication for videolaryngoscope
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 guided intubation | Procedure or surgery | 70 degree, 90 degree |
| GlideScope® | Device | 70 degree, 90 degree |
Primary outcome
Time to Intubation
Time frame: Intraoperative intubation
Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (>30 mmHg)
10 secondary outcomes
Success Rate of Intubation
Time frame: Intraoperative intubation
Difficulty of Intubation Measured Using Visual Analogue Scale
Time frame: Intraoperative intubation
Number of Participants for Whom External Laryngeal Manipulation Was Necessary
Time frame: Intraoperative intubation
Cormack-Lehan Grade
Time frame: Intraoperative intubation
Mallampati Grade
Time frame: Intraoperative anesthetic induction
Thyromental Distance
Time frame: Intraoperative anesthetic induction
Postoperative Sore Throat Measured Using Visual Analogue Scale
Time frame: at 1, 24 hr postoperatively
Mean Blood Pressure
Time frame: Intraoperative intubation
Heart Rate
Time frame: Intraoperative intubation
Airway Injury
Time frame: Intraoperative intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29332445Lee YC, Lee J, Son JD, Lee JY, Kim HC. Stylet angulation of 70 degrees reduces the time to intubation with the GlideScope(R): A prospective randomised trial. J Int Med Res. 2018 Apr;46(4):1428-1438. doi: 10.1177/0300060517741065. Epub 2018 Jan 14.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Glidescope guided intubation and GlideScope® in people with Cholecystitis and Stomach Cancer, run by Keimyung University Dongsan Medical Center.
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 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: finished, as of the sponsor's last update on 9 Jun 2017. 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 9 Jun 2017). 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?
Time to Intubation (time frame: Intraoperative intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02547064, which also lists 1 linked publication.
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 9 Jun 2017.