IntubationNCT03120546
Cervical Spine Motion During Tracheal Intubation: Video Laryngoscope vs Rigid Video Stylet
A study testing rigid video stylet intubation and video laryngoscope intubation in people with Intubation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In this study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation
- What is being tested?
- rigid video stylet intubation and video laryngoscope intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jul 2017to 31 Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years undergoing elective endovascular cerebral aneurysm coiling to general anesthesia in a neuroangiography suite
Who cannot join
- Patients with upper airway abnormalities such as inflammation, abscesses, tumors, polyps, and trauma
- Patients with a medical history of gastroesophageal reflux disease and previous airway surgery, at high risk for aspiration, coagulation disorders, or a Hunt Hess grade of 3-5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of Cervical Spine Motion During Tracheal Intubation Using Video Laryngoscope or Rigid Video Stylet in Patients With Simulated Cervical Immobilization
In this study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization.
Read the detailed description
In patients with an unstable cervical spine, neck extension during tracheal intubation may result in harmful events such as spinal cord injury. Thus, it is important to minimize cervical spine motion in these patients. In this randomized crossover study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization.
- Conditions
- Intubation
- Being tested
- rigid video stylet intubation, video laryngoscope intubation
- Keywords
- cervical spine motion, video laryngoscope, rigid video stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rigid video stylet intubationDevice
intubation using rigid video stylet
video laryngoscope intubationDevice
intubation using video laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | rigid video stylet intubation - video laryngoscope intubation Receives: Device: rigid video stylet intubation; Device: video laryngoscope intubation |
| Group B | Experimental | video laryngoscope intubation - rigid video stylet intubation Receives: Device: rigid video stylet intubation; Device: video laryngoscope intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum cervical spine motion
maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments
Measured: during tracheal intubation
Secondary outcomes (2)
intubation time
time interval between insertion of the device into the oral cavity and its removal
Measured: during tracheal intubation
number of intubation trial
number of intubation trial
Measured: during tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start25 Jul 2017
- Primary completion31 Oct 2017
- Study completion31 Oct 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Kyong Kim, Seoul National University Hospital
- Investigators
- Tae Kyong Kim, M.D., Ph. D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120546
- Sponsor's protocol ID
- McGrath vs Optiscope
- Status last verified
- Feb 2018
- First submitted
- 14 Apr 2017
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Cervical Spine Motion During Tracheal Intubation Using Video Laryngoscope or Rigid Video Stylet in Patients With Simulated Cervical Immobilization
- ClinicalTrials.gov ID
- NCT03120546
- Acronym / sponsor ID
- McGrath vs Optiscope
- Conditions
- Intubation
- Keywords
- cervical spine motion, video laryngoscope, rigid video stylet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 19 Apr 2017 (actual)
- 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.
In this study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization.
Detailed description
In patients with an unstable cervical spine, neck extension during tracheal intubation may result in harmful events such as spinal cord injury. Thus, it is important to minimize cervical spine motion in these patients. In this randomized crossover study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: rigid video stylet intubation, Device: video laryngoscope intubationrigid video stylet intubation - video laryngoscope intubation |
| Group B | Experimental | Device: rigid video stylet intubation, Device: video laryngoscope intubationvideo laryngoscope intubation - rigid video stylet intubation |
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 aged 18-80 years undergoing elective endovascular cerebral aneurysm coiling to general anesthesia in a neuroangiography suite
Key exclusion criteria (2 listed)
- Patients with upper airway abnormalities such as inflammation, abscesses, tumors, polyps, and trauma
- Patients with a medical history of gastroesophageal reflux disease and previous airway surgery, at high risk for aspiration, coagulation disorders, or a Hunt Hess grade of 3-5
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 |
|---|---|---|
| rigid video stylet intubationintubation using rigid video stylet | Device | Group A, Group B |
| video laryngoscope intubationintubation using video laryngoscope | Device | Group A, Group B |
Primary outcome
maximum cervical spine motion
Time frame: during tracheal intubation
maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments
2 secondary outcomes
intubation time
Time frame: during tracheal intubation
number of intubation trial
Time frame: during tracheal intubation
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 14 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Tae Kyong Kim, M.D., Ph. D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rigid video stylet intubation and video laryngoscope intubation 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 1 inclusion and 2 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 14 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?
maximum cervical spine motion (time frame: during tracheal 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 14 Feb 2018.