IntubationNCT03000088
Stylet Angle for McGrath Videolaryngoscopy
An observational study of Intubation, run by Ajou University School of Medicine.
Trial summary
The McGrath videolaryngoscope (VL) provides excellent laryngoscopic views, but directing an endotracheal tube is not easy, so routine using of stylet is recommended. The goal of this study is to determine the appropriate angle of stylet by comparing time to intubation (TTI). Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Intubation
- What is being tested?
- intubate with 60° angled stylet
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Aug 2016
- Phase
- Observational
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for elective surgery requiring orotracheal intubation in our hospital
Who may be able to join
- an American Society of Anesthesiologists physical status (ASA) 1 or 2
Who cannot join
- a suspected difficult airway (Mallampati score Ⅳ)
- known cervical spine injury
- required rapid sequence induction
- emergency operation
About this study
The McGrath videolaryngoscope (VL) provides excellent laryngoscopic views, but directing an endotracheal tube is not easy, so routine using of stylet is recommended. The goal of this study is to determine the appropriate angle of stylet by comparing time to intubation (TTI).
- Conditions
- Intubation
- Being tested
- intubate with 60° angled stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubate with 60° angled styletDevice
intubate with 60° angled styletDevice
| Study group | Role | What they receive |
|---|---|---|
| 60° angle group | intubate using McGrath Videolaryngoscope with 60° angled stylet Receives: Device: intubate with 60° angled stylet | |
| 90°angle group | intubate using McGrath Videolaryngoscope with 90° angled stylet Receives: Device: intubate with 60° angled stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubation
Measured: 10 minutes around intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 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.
- Other trials for IntubationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyoung Lee, Ajou University School of Medicine
- Investigators
- Jiyoung Lee, MD, Principal investigator, Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000088
- Sponsor's protocol ID
- AJIRB-MED-DE4-15-414
- Status last verified
- Mar 2017
- First submitted
- 19 Dec 2016
- Last updated
- 13 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stylet Angle for McGrath Videolaryngoscopy
- ClinicalTrials.gov ID
- NCT03000088
- Acronym / sponsor ID
- AJIRB-MED-DE4-15-414
- Conditions
- Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Posted 13 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The McGrath videolaryngoscope (VL) provides excellent laryngoscopic views, but directing an endotracheal tube is not easy, so routine using of stylet is recommended. The goal of this study is to determine the appropriate angle of stylet by comparing time to intubation (TTI).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60° angle group | – | Device: intubate with 60° angled styletintubate using McGrath Videolaryngoscope with 60° angled stylet |
| 90°angle group | – | Device: intubate with 60° angled styletintubate using McGrath Videolaryngoscope with 90° angled stylet |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for elective surgery requiring orotracheal intubation in our hospital
Key inclusion criteria (1 listed)
- an American Society of Anesthesiologists physical status (ASA) 1 or 2
Key exclusion criteria (4 listed)
- a suspected difficult airway (Mallampati score Ⅳ)
- known cervical spine injury
- required rapid sequence induction
- emergency operation
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 |
|---|---|---|
| intubate with 60° angled stylet | Device | 60° angle group |
| intubate with 60° angled stylet | Device | 90°angle group |
Primary outcome
Time to Intubation
Time frame: 10 minutes around intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- 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.
Jiyoung Lee, MD principal investigator
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation, run by Ajou University School of Medicine.
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 4 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 13 Apr 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 13 Apr 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: 10 minutes around intubation). 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 13 Apr 2017.