IntubationNCT02931019
The Effect of Head Position on the Intubating Condition Using Fiberoptic Bronchoscopy
A study testing Intubation in people with Intubation and Posture, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
For better view of fiberoptic intubation, the posture of neck is compared between neck flexion and extension. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Intubation, Posture
- What is being tested?
- Intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Oct 2016to 2 Jan 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class 1 or 2
- scheduled for general anesthesia with endotracheal intubation
- decided to join this clinical study voluntarily
Who cannot join
- history of difficult intubation
- anticipated the difficult intubation: Total airway score > 6, upper lip bite test grade III, with cervical spine disease, history of head or neck surgery
- risk of aspiration
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
About this study
For better view of fiberoptic intubation, the posture of neck is compared between neck flexion and extension.
- Conditions
- Intubation, Posture
- Being tested
- Intubation
- Keywords
- fiberoptic, intubation, posture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntubationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| neck flexion first | Experimental | With specific head posture, intubation is done under flexible fiberoscopy guide.
In this arm, at the position with neck flexion, fiberoscopy is pulled into the mouth and get the photo of laryngeal view. After then, neck position is changed to neck extension, And the laryngeal view is gotten in the same way. Receives: Procedure: Intubation |
| neck extension first | Experimental | In this arm, at the position with neck extension, fiberoscopy is pulled into the mouth and get the photo of laryngeal view. After then, neck position is changed to neck flexion, And the laryngeal view is gotten in the same way. Receives: Procedure: Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
POGO score
The percentage of glottic opening
Measured: a week (after get the picture)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study start13 Oct 2016
- Primary completion2 Jan 2017
- Study completion2 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanghee Park, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931019
- Sponsor's protocol ID
- CNUHH-2016-120
- Other IDs
- Institutional Review Board
- Status last verified
- May 2017
- First submitted
- 10 Oct 2016
- Last updated
- 15 May 2017
- Results posted
- No
Publications
Park S, Lee HG, Choi JI, Lee S, Jang EA, Bae HB, Rhee J, Yang HC, Jeong S. Comparison of vocal cord view between neutral and sniffing position during orotracheal intubation using fiberoptic bronchoscope: a prospective, randomized cross over study. BMC Anesthesiol. 2019 Jan 5;19(1):3. doi: 10.1186/s12871-018-0671-9.
PubMed 30611215
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Head Position on the Intubating Condition Using Fiberoptic Bronchoscopy
- ClinicalTrials.gov ID
- NCT02931019
- Acronym / sponsor ID
- CNUHH-2016-120
- Conditions
- Intubation, Posture
- Keywords
- fiberoptic, intubation, posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 2 Jan 2017 (actual)
- Study completion
- 2 Jan 2017 (actual)
- First posted
- 12 Oct 2016 (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.
For better view of fiberoptic intubation, the posture of neck is compared between neck flexion and extension.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neck flexion first | Experimental | Procedure: IntubationWith specific head posture, intubation is done under flexible fiberoscopy guide. In this arm, at the position with neck flexion, fiberoscopy is pulled into the mouth and get the photo of laryngeal view. After then, neck position is changed to neck extension, And the laryngeal view is gotten in the same way. |
| neck extension first | Experimental | Procedure: IntubationIn this arm, at the position with neck extension, fiberoscopy is pulled into the mouth and get the photo of laryngeal view. After then, neck position is changed to neck flexion, And the laryngeal view is gotten in the same way. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class 1 or 2
- scheduled for general anesthesia with endotracheal intubation
- decided to join this clinical study voluntarily
Key exclusion criteria (3 listed)
- history of difficult intubation
- anticipated the difficult intubation: Total airway score > 6, upper lip bite test grade III, with cervical spine disease, history of head or neck surgery
- risk of aspiration
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 |
|---|---|---|
| Intubation | Procedure or surgery | neck extension first, neck flexion first |
Primary outcome
POGO score
Time frame: a week (after get the picture)
The percentage of glottic opening
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 15 May 2017.
- Derived from this study: PubMed 30611215Park S, Lee HG, Choi JI, Lee S, Jang EA, Bae HB, Rhee J, Yang HC, Jeong S. Comparison of vocal cord view between neutral and sniffing position during orotracheal intubation using fiberoptic bronchoscope: a prospective, randomized cross over study. BMC Anesthesiol. 2019 Jan 5;19(1):3. doi: 10.1186/s12871-018-0671-9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation in people with Intubation and Posture, run by Chonnam 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 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 15 May 2017. 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?
POGO score (time frame: a week (after get the picture)). 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 NCT02931019, 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 15 May 2017.