AnesthesiaNCT03524547
Endotracheal Tube Shapes for Intubation With Videolaryngoscope
A study testing J shaped stylet used for endotracheal intubation and 60-degrees stylet used for endotracheal intubation in people with Anesthesia, run by Eunah Cho, MD at 1 site in South Korea.
Trial summary
In this study, investigators will compare the efficacy of two shapes of endotracheal tube molded by stylet in endotracheal intubation using videolaryngoscope (McGrath MAC®). The participants will randomly be divided into two groups; J-shaped tube and 60-degrees-curved tube. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- J shaped stylet used for endotracheal intubation and 60-degrees stylet used for endotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 May 2018to 4 Jul 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for the surgery under general anesthesia
- Adult patients from 18 years to 65 years
- American society of Anesthesiologist physical status 1,2,3
Who cannot join
- Previously diagnosed for the difficult intubation
- Pregnancy
- Obesity (Body mass index over 40 g/m^2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Endotracheal Tube Shapes for Intubation With Videolaryngoscope in Normal Airways
In this study, investigators will compare the efficacy of two shapes of endotracheal tube molded by stylet in endotracheal intubation using videolaryngoscope (McGrath MAC®). The participants will randomly be divided into two groups; J-shaped tube and 60-degrees-curved tube.
Read the detailed description
Since the intubation using videolaryngoscope does not need straightened oral-pharyngeal-laryngeal axis, certain curvature of endotracheal tube is needed for the successful intubation using the videolaryngoscope.
Participants in both groups will be intubated with videolaryngoscope (McGrath MAC®). Stylet will be inserted in the endotracheal tubes and will be bent to a specific shape by the assigned group. In the J-shaped tube group, endotracheal tube will be molded to a shape similar to the blade of the videolaryngoscope (McGrath MAC®). In the 60-degrees-curved tube group, endotracheal tube will be bent 60 degrees. Time to intubation, intubation attempts and ease of intubation wil be assessed.
- Conditions
- Anesthesia
- Being tested
- J shaped stylet used for endotracheal intubation, 60-degrees stylet used for endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J shaped stylet used for endotracheal intubationDevice
After inserting a stylet into the endotracheal tube, the tube will be molded into a J-shape.
60-degrees stylet used for endotracheal intubationDevice
After inserting a stylet into the endotracheal tube, the tube will be bent 60-degrees.
| Study group | Role | What they receive |
|---|---|---|
| J-shaped | Experimental | Endotracheal tube will be molded into a J-shape that is similar to that of Macintosh type blade of a McGrath MAC® videolaryngoscope. Receives: Device: J shaped stylet used for endotracheal intubation |
| 60-degrees | Active comparator | Endotracheal tube will be bent 60 degrees. Receives: Device: 60-degrees stylet used for endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubate
the time took from the blade passing through the incisor teeth of the patient to the first end tidal CO2 appears on the anesthesia monitor screen.
Measured: 20 minutes after induction started.
Secondary outcomes (2)
Numbers of intubation attempts
numbers of attempts for the successful endotracheal intubation
Measured: 20 minutes after induction started.
Level of difficulty in intubation
easy, moderate, difficult
Measured: 20 minutes after induction started.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start28 May 2018
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunah Cho, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
- Investigators
- Eunah Cho, M.D., Principal investigator, Kangbuk Samsung HospitalHyunyoung Lim, M.D., Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524547
- Sponsor's protocol ID
- 2018-01-033-001
- Other IDs
- 2018-01-016-003
- Status last verified
- Jul 2018
- First submitted
- 2 May 2018
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endotracheal Tube Shapes for Intubation With Videolaryngoscope in Normal Airways
- ClinicalTrials.gov ID
- NCT03524547
- Acronym / sponsor ID
- 2018-01-033-001
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Eunah Cho, MDUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 15 May 2018 (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 will compare the efficacy of two shapes of endotracheal tube molded by stylet in endotracheal intubation using videolaryngoscope (McGrath MAC®). The participants will randomly be divided into two groups; J-shaped tube and 60-degrees-curved tube.
Detailed description
Since the intubation using videolaryngoscope does not need straightened oral-pharyngeal-laryngeal axis, certain curvature of endotracheal tube is needed for the successful intubation using the videolaryngoscope.
Participants in both groups will be intubated with videolaryngoscope (McGrath MAC®). Stylet will be inserted in the endotracheal tubes and will be bent to a specific shape by the assigned group. In the J-shaped tube group, endotracheal tube will be molded to a shape similar to the blade of the videolaryngoscope (McGrath MAC®). In the 60-degrees-curved tube group, endotracheal tube will be bent 60 degrees. Time to intubation, intubation attempts and ease of intubation wil be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| J-shaped | Experimental | Device: J shaped stylet used for endotracheal intubationEndotracheal tube will be molded into a J-shape that is similar to that of Macintosh type blade of a McGrath MAC® videolaryngoscope. |
| 60-degrees | Active comparator | Device: 60-degrees stylet used for endotracheal intubationEndotracheal tube will be bent 60 degrees. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for the surgery under general anesthesia
- Adult patients from 18 years to 65 years
- American society of Anesthesiologist physical status 1,2,3
Key exclusion criteria (3 listed)
- Previously diagnosed for the difficult intubation
- Pregnancy
- Obesity (Body mass index over 40 g/m^2)
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 |
|---|---|---|
| J shaped stylet used for endotracheal intubationAfter inserting a stylet into the endotracheal tube, the tube will be molded into a J-shape. | Device | J-shaped |
| 60-degrees stylet used for endotracheal intubationAfter inserting a stylet into the endotracheal tube, the tube will be bent 60-degrees. | Device | 60-degrees |
Primary outcome
Time to intubate
Time frame: 20 minutes after induction started.
the time took from the blade passing through the incisor teeth of the patient to the first end tidal CO2 appears on the anesthesia monitor screen.
2 secondary outcomes
Numbers of intubation attempts
Time frame: 20 minutes after induction started.
Level of difficulty in intubation
Time frame: 20 minutes after induction started.
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 9 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Eunah Cho, M.D. principal investigator
Kangbuk Samsung Hospital
Hyunyoung Lim, M.D. principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing J shaped stylet used for endotracheal intubation and 60-degrees stylet used for endotracheal intubation in people with Anesthesia, run by Eunah Cho, MD 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 3 inclusion and 3 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 Jul 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?
Time to intubate (time frame: 20 minutes after induction started.). 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 9 Jul 2018.