Orotracheal IntubationPhase 4NCT02642367
Stylet Use for McGrath Videolaryngoscope
A Phase 4 study testing McGrath videolaryngoscope, McGrath videolaryngoscope with Intubating stylet (Mallinckrodt) and rocuronium in people with Orotracheal Intubation, run by Ajou University School of Medicine at 2 sites in South Korea.
Trial summary
The routine use of a styletted endotracheal tube during videolaryngoscopy is advocated by some manufacturers, but styletted endotracheal tube can elicit rare but potentially serious complications. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Orotracheal Intubation
- What is being tested?
- McGrath videolaryngoscope, McGrath videolaryngoscope with Intubating stylet (Mallinckrodt) and rocuronium
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2016to May 2016
- Phase
- Phase 4
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I or II undergoing orotracheal intubation for elective surgery
Who cannot join
- cervical spine injury
- rapid sequence induction
- body mass index> 35 kg/m2
- airway pathology
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Ajou University Hospital
Suwon, Gyeongki-do, 443-721
Ajou University Hospital
Suwon, 443-721
About this study
Official title: Comparison of With or Without Use of Stylet for Endotracheal Intubation With McGrath Videolaryngoscope
The routine use of a styletted endotracheal tube during videolaryngoscopy is advocated by some manufacturers, but styletted endotracheal tube can elicit rare but potentially serious complications. We compared the intubation time and success rate whether or not use of stylet for endotracheal intubation with McGrath videolaryngoscope.
- Conditions
- Orotracheal Intubation
- Being tested
- McGrath videolaryngoscope, McGrath videolaryngoscope with Intubating stylet (Mallinckrodt), rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath videolaryngoscopeDevice
without use of stylet
McGrath videolaryngoscope with Intubating stylet (Mallinckrodt)Device
use of stylet
rocuroniumDrug
Also called rocumeron
tracehal intubation was performed 2 min after rocuronium injection with McGrath videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| no use of stylet | Experimental | Endotracheal intubation was performed 2 min after rocuronium injection without use of stylet with McGrath videolaryngoscope after endotracheal tube was rolled up circularly for 3 min Receives: Device: McGrath videolaryngoscope; Drug: rocuronium |
| use of stylet | Active comparator | Endotracheal intubation was performed 2 min after rocuronium injection using a styletted endotracheal tube with McGrath videolaryngoscope Receives: Device: McGrath videolaryngoscope with Intubating stylet (Mallinckrodt); Drug: rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
time the blade passed the lips until endtidal CO2 was detected
Measured: 2 min after rocuronium injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orotracheal 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
- Investigators
- Jong Yeop Kim, Study director, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642367
- Sponsor's protocol ID
- AJIRB-MED-DE4-15-345
- Status last verified
- Nov 2016
- First submitted
- 22 Dec 2015
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of With or Without Use of Stylet for Endotracheal Intubation With McGrath Videolaryngoscope
- ClinicalTrials.gov ID
- NCT02642367
- Acronym / sponsor ID
- AJIRB-MED-DE4-15-345
- Conditions
- Orotracheal Intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Dec 2015 (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 routine use of a styletted endotracheal tube during videolaryngoscopy is advocated by some manufacturers, but styletted endotracheal tube can elicit rare but potentially serious complications. We compared the intubation time and success rate whether or not use of stylet for endotracheal intubation with McGrath videolaryngoscope.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no use of stylet | Experimental | Device: McGrath videolaryngoscope, Drug: rocuroniumEndotracheal intubation was performed 2 min after rocuronium injection without use of stylet with McGrath videolaryngoscope after endotracheal tube was rolled up circularly for 3 min |
| use of stylet | Active comparator | Device: McGrath videolaryngoscope with Intubating stylet (Mallinckrodt), Drug: rocuroniumEndotracheal intubation was performed 2 min after rocuronium injection using a styletted endotracheal tube with McGrath videolaryngoscope |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status I or II undergoing orotracheal intubation for elective surgery
Key exclusion criteria (4 listed)
- cervical spine injury
- rapid sequence induction
- body mass index> 35 kg/m2
- airway pathology
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 |
|---|---|---|
| McGrath videolaryngoscopewithout use of stylet | Device | no use of stylet |
| McGrath videolaryngoscope with Intubating stylet (Mallinckrodt)use of stylet | Device | use of stylet |
| rocuroniumAlso: rocumerontracehal intubation was performed 2 min after rocuronium injection with McGrath videolaryngoscope | Drug | no use of stylet, use of stylet |
Primary outcome
intubation time
Time frame: 2 min after rocuronium injection
time the blade passed the lips until endtidal CO2 was detected
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 23 Nov 2016.
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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.
Jong Yeop Kim study director
Ajou University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing McGrath videolaryngoscope, McGrath videolaryngoscope with Intubating stylet (Mallinckrodt) and rocuronium in people with Orotracheal Intubation, run by Ajou University School of Medicine at 2 sites 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 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
intubation time (time frame: 2 min after rocuronium injection). 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 23 Nov 2016.